We offer clear, authentic, easy-to-follow standard operating procedures for small and medium-sized pharmaceutical companies.

Our SOPs comply with international standards like Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Distribution Practices (GDP), and Good Automated Manufacturing Practices (GAMP).

Look no further if you are looking for ready-to-use standard operating procedures for your production operations, quality management, warehouses, analytical, and microbiology laboratories.

Each procedure is written in plain English by industry experts with examples and instructions to facilitate smooth implementation. Forms and templates are complemented where needed, making it easy to follow.

Our procedures are not just general guidelines but detailed instructions that can help you establish your systems from the ground up.

Please check out the list of SOPs, manuals, and sample pages below. Become a member to unlock all documents.

1.0 GMP Standard Operating Procedures (SOP)

1.1 Validation Procedures

1.1.1 Process/Cleaning/Method Validation Procedures

Validation – Concept and Procedure

This SOP describes general validation concepts and practices. It includes the philosophy of validation, validation approaches, design qualification, installation qualification, operational qualification, performance qualification, cleaning validation, method validation, and computer systems validation.

Revalidation Procedure

This procedure contains step-by-step instructions on initiating revalidation categories, changes that warrant revalidation programs, and the basic steps of the revalidation procedure.

Method Validation Procedure

This procedure provides a guideline for a validation Technician on the characteristics that must be considered during the validation of an analytical testing procedure.

Procedure for Cleaning Validation

This SOP describes the types of cleaning processes and cleaning agents of process equipment and their validation calculation of acceptance limits for swabs, analytical method validation and revalidation approaches.

Validation of Laboratory Instruments

This SOP describes the validation practices for laboratory instruments/equipment to be validated. This procedure has practical instructions on Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to be performed.

Equipment Specification and Qualification

This procedure describes the procedures for procuring equipment, incorporating standardized demand specifications and Installation Qualification documentation.

In-House Trial Procedure

This SOP defines standard procedures for organizing Trials/Evaluation Studies for process improvement, equipment capability, and validation studies.

Cleaning, Derouging and Passivation of the Stainless Steel Parts of the Purified Water System

This SOP defines the procedure for cleaning, passivating, and derouging the purified water system at a GMP site.

Cleaning Validation Analytical Methods

The scope of this procedure includes the validation of

1. Sampling methods are used to determine residues after cleaning the manufacturing and packaging equipment used to produce commercial products.

2. Analytical methods to detect residue after cleaning.

Validation Deviation Management

This Standard Operating Procedure aims to describe the actions required to handle deviations encountered during validation studies.

Validation Master Plan

The Validation Master Plan is designed to provide a planned and systematic framework for all validation activities. This document will also ensure that the manufacturing facilities comply with the local applicable GMP regulations and site requirements for validation.

Process Validation Guideline

This policy applies to all production processes used to manufacture commercial drug products or in-process materials for commercial drug products.

Equipment Validation Guideline

This SOP describes the approach and methods for equipment qualification at a GMP manufacturing site. This validation guideline aims to provide a clear statement of the scope, validation approach, and testing requirements for equipment validation.

Facility and Utility Validation Guideline

This SOP aims to provide a clear statement of the scope, validation approach, and testing required for validating the facilities and utilities that are involved, directly or indirectly, in the manufacturing processes at a GMP site.

Process Validation Sampling

This SOP applies to validation sampling and testing for all new product introductions and when changes to manufacturing procedures, manufacturing equipment, or raw materials warrant process validation.

Raw Material Evaluation Process

The purpose of this Standard Operating Procedure is to describe the evaluation process for a new, or a change of, source raw material used to manufacture Drug Products at the GMP manufacturing facility.

Process Validation for Liquid and Solid Dosage Manufacturing

This SOP outlines the requirements for preparing, reviewing, approving, and executing process validation protocols at a GMP Manufacturing Site.

Cleaning Validation Guideline

This SOP describes the approach and methods for validating, cleaning, and sanitation practices involved in GMP processes.

Guideline for the development of a Validation Project Plan

The Validation Project Plan SOP aims to:

1. Establish a plan for the overall validation effort and lifecycle that describes the extent of the validation required to meet the Site and regulatory requirements.

2. Define Validation Deliverables for the computer system.

3. Provide a standardized format for Validation Project Plans.

Development of a User and Functional Requirement Specification

This procedure is a guideline for developing a User Requirement Specification (URS) document and a Functional Requirement Specification (FRS) document for a computer system at a GMP manufacturing facility.

Handling of Material Used for Trials

This SOP provides guidelines to ensure that materials brought into the manufacturing plant for trial purposes are still accompanied by documentation so that their usage is recorded and reconciled, and the equipment that they contact is also recorded.

Periodic Review of Systems and Processes

This SOP covers the validated direct impact systems (including the facilities, utilities, equipment, process control systems, and computer/automation systems) and Processes at a GMP site.

Packaging Trials

This SOP defines common procedures for organizing packaging trials, including the allocation of responsibility for coordinating the trial and suggestions for what documentation to consider when preparing the trial documentation.

Validation of Autoclaves, Autoclave Loads and Cycle

This standard operating procedure outlines the validation approach for autoclaves, autoclave loads, and autoclave cycles at a GMP site.

Heat Penetration Heat Distribution study

Using a Heat Penetration Study, demonstrate that each of the proposed cycles will, with a high degree of assurance, sterilize a defined load configuration for the worst-case load.

Guidance for the use of Risk Assessment in Validation

This SOP details the standard methodology for performing GMP/Quality Risk Assessments during Validation activities.

Guideline for the Validation of Aseptic Processing

This SOP aims to provide suggestions and considerations for designing and preparing aseptic media fill validation protocols and reports.

Maximum Safe Carry-Over (MSCO) Determination

This procedure instructs the user on the operations required to conduct a Maximum Safe Carry-Over Determination (MSCO) for a piece of equipment or product equipment grouping.

Selection and Use of Biological Indicators during Validation Studies Processing

This SOP demonstrates the use of Biological Indicators (BIs) to validate and monitor the sterilization cycle process.

Management of Validation Protocols and Reports

This SOP demonstrates how to assign a project number to the validation project and how to prepare and execute validation protocols and reports.

Cleaning Validation Master Plan – Non Sterile Solid

This SOP aims to summarise the overall intentions and approach to validating the cleaning equipment and procedures involved in the manufacture of sterile veterinary biologic products.

Cleaning Validation Master Plan – Veterinary Biologicals

The objective of this procedure is to demonstrate how to prepare a validation master plan for biological product manufacturing,

Procedure for Performing Steam in Place (SIP) Validation

This Standard Operating Procedure aims to outline the validation approach for the Sterilization-in-place (SIP) process validation of all biological production area vessels, both in empty and full states, associated pipework, transfer lines, filters, and manifolds at a GMP site.

Procedure for Cleaning Validation Coverage Testing

This Standard Operating Procedure will define the procedure to test the spray coverage of Clean-in-Place (CIP) Systems or Cleaning systems procedures designed for stainless steel vessels.

Calibration Procedure (Ice Point) for Thermometers and Thermocouples

This SOP is to provide an established procedure for performing temperature calibration on equipment to control standards at the GMP site.

Method Validation Master Plan

The objective of the SOP is to ensure that validation principles are applied appropriately and to establish documented evidence that all test methods are performed consistently and reproducibly.

1.1.2 Computer System Validation Procedures

Computerized System Validation

This SOP’s objective is to provide an overview of the Qualification/Validation of computerized systems directly associated with or supporting regulatory compliance requirements for developing, testing, manufacturing, and distributing medicinal products.

Computer Validation Guideline

This SOP’s objective is to describe the approach and methods for validating computer systems involved in GXP processes employed in the GMP manufacturing facility.

Impact Assessment for Computerised Systems

This SOP aims to provide a method of assessing and determining the validation requirements for computerized systems and controllers.

Functional Testing Guide for Computerized System

This SOP guides functional testing during the development or change of computerized systems with a GxP impact at a GMP manufacturing site.

Design Qualification Guidelines

The purpose of this SOP is to provide guidelines on conducting Design Qualification (DQ) during the conceptual and detailed design phase for implementing a GMP facility.

Protecting the Reliability of Electronic GMP Documents

This SOP applies to records created, processed, used, or stored by (or for) the GMP Manufacturing site that are the output of a computerized system.

Guideline For The Development of A Computer Validation Project Plan

The VPP aims to establish a plan for the validation lifecycle and describe the extent of the validation effort required to meet Site and regulatory requirements.

Risk Assessment for Computer Validation Systems

A Risk Assessment may be applied to computerised systems to enable the validation effort to be targeted at the areas and functions that most require it.

Development of A Functional Requirement Specification for Computer Systems

This SOP is a guideline for developing a Functional Requirement Specification (FRS) document for a computer system at a GMP manufacturing facility.

Conducting an Electronic Record and Signature Assessment

This Standard Operating Procedure aims to provide instruction and practical guidelines for conducting an Electronic Record and Electronic Signature Assessment.

Guideline for the Validation of Excel Spreadsheets

This SOP provides guidelines for a suitable approach to validating Excel spreadsheets used in direct or indirect GxP-related activities at all GMP facilities.

Computer Validation Master Plan

This SOP provides an outline of the computer validation program’s principles and objectives for the GMP site.

240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Additional documents are included each month. All are written and updated by GMP experts. Check out sample previews. Access to exclusive content for an affordable fee.

1.1.3 Validation Templates

1.2 Quality Assurance and Compliance Procedures (SOPs)

How to Write Standard Operating Procedure

This SOP describes a standard procedure format you can create and use immediately for your quality procedures.

All Documents – Classification, Definition, and Approval Matrix

In this SOP, you will find all types of quality and Technical/Master file documents to build up a sound quality management system for your manufacturing sites.

GMP Quality Documentation Management and Change Control

This SOP describes how to generate new quality documents or change control of existing documents, review of quality documents, satellite file management, and the role of document author, approver, document control officer, and satellite file administrator.

Documentation Rule for GMP Documents

This SOP describes the principles to be followed in GMP documents, including the entry of data and information, signature requirements, and correction techniques for incorrectly entered data or information.

GMP Quality Documentation – Control, Tracking and Distribution

This SOP mainly describes the role of the document control officer during the initiation, creation, circulation, and approval of new quality-related documents.

Preparation, Maintenance, and Change Control of Master Documents

This SOP mainly focused on managing master file documents like specifications, control methods, raw materials, finished goods, packaging specifications, test reports, stability files, etc., which are required to be generated during product registration in the market.

Pharmaceutical Deviation Report System

This SOP categorizes deviations between production, audit, quality improvements, and EHS deviations. It describes the management responsibilities of initiating deviations, analyzing them, investigating them, determining assignable causes, and taking corrective and preventative actions.

Vendor Selection and Evaluation Procedure

This SOP describes the procedure for conducting the vendor assessment and purchasing raw materials, controlling packaging components, laboratory supplies, engineering supplies, and imported finished goods from the vendor.

Vendor Certification Procedure

This procedure describes how a vendor may be certified to supply materials or services.

Pharmaceutical Product Complaint Procedure

This procedure covers the receipt, logging, evaluation, investigation, and reporting of all customer complaints for the marketed products.

Procedure for Annual Product Quality Review

This SOP demonstrate how to prepare annual product review, evaluate data and trends and identify any preventative or corrective action that would lead to product quality improvements and report them to management.

Manufacturing Rework Procedure

This SOP contains the step-by-step instructions to be followed when reworking an in-process or completed finished good is required.

Procedure for Product Identification and Traceability

This SOP defines the method for identifying all contributing materials that could affect product quality and ensuring their full traceability.

GMP Audit Procedures

This SOP describes the process of planning, performing, reporting on, and following up on various audits of your systems, such as Internal Quality audits.

Example of Checklist for Batch Documentation

This SOP describes identifying all documentation relevant to a production process, namely “Batch Documentation Checklists,” and ensuring that authorized persons complete the checklists.

Evaluation of Batch Documentation and Release for Sale

This SOP describes collecting and evaluating batch-related GMP documents generated during production before an authorized person can release the batch for sale.

GMP Training Procedure

This SOP describes how to design and deliver GMP training for manufacturing employees, design training assessments, record assessments, and prepare training reports.

How to Write GMP Training Materials

This simple SOP contains instructions on how to write GMP training materials, identify training requirements and available resources, and prepare training aid checklists for your manufacturing employees.

House Keeping Audit Procedure

This SOP describes the requirements, checklists, and reporting procedures for housekeeping audits.

Management and Control of Contract Work

The procedure describes the management and control of contract work provided by the contractors for packaging and finished products for your company and control of contract works done by your company on behalf of others.

Criteria for Sourcing of Raw Materials, Packaging Components, and Imported Finished Goods

This SOP describes approving an external vendor/manufacturer supplying products to your company.

Quality Concern Investigation Process

This SOP contains instructions for conducting investigations after a deviation is raised. Apply Root Cause Investigation and implement corrective actions.

Change Management System

This standard operating procedure provides a standardized procedure and framework for initiating, authorizing, planning, and implementing any change to a GMP system.

Cross-Functional Investigation

This procedure describes the process for initiating, communicating, conducting, and documenting Cross-Functional Investigations (CFI) related to process, system, product, material, facility, and laboratory deviations.

Quality Risk Management Techniques

This SOP defines the approach to Quality Risk Management (QRM) of a GMP site and gives practical examples of tools that may be used to facilitate the process.

Root Cause Analysis Investigation Procedure

This SOP covers the use and management of the Root Cause Investigation Tool, which is designed on the principles of DMAIC (Define, Measure, Analyse, Implement, and Control).

Classification of Defects in Manufacturing Operation

This SOP covers the requirements for:

1. Identifying defects and their respective AQLs (Acceptable Quality Limits); and

2. Taking action when critical, major, or minor defects are encountered during the Production/ Packaging Process.

Classification of Defects for Incoming Packaging Components

This SOP explains the AQL levels and categories of defects for all incoming packaging components received and tested at a GMP site. It also determines the responsibility levels for the acceptance or rejection when an Out of Specification (OOS) occurs.

External Audit Procedure

This SOP covers the method for regular GMP audits of suppliers, distributors, service providers, and contract laboratories.

Personal Hygiene, Jewellery and Clothing Policy

This SOP aims to outline GMP requirements for personal hygiene, clothing, and jewelry for all colleagues (employees, visitors, and contractors) entering a GMP site.

Good Documentation Practice

Good documentation constitutes an essential part of any quality system. Written documentation prevents spoken communication errors and permits batch history tracing.

Product Quality Reviews for Contract-Manufactured Products

This procedure describes a process for preparing, reviewing, and appraising Product Quality Reviews (PQR) for products that are the responsibility of Contract Operations.

Corrective and Preventative Actions

To define the process for control of non-conformance, deficiencies, or quality problems that require corrective and preventive action (CAPA).

Quality Assurance Change Control Procedure

This standard Operating Procedure describes the process for implementing a change that will impact the product or any process within the quality management system.

1.2.3 Quality Assurance Templates

1.3 Quality Control Laboratory Procedures (SOP)

Retest Dating of Raw Materials

This procedure describes how to run the expired stock report and how to define the requirements for retesting and assignment of storage periods for active ingredients, excipients, and raw materials.

Calibration Policies for Laboratory Instruments

This SOP describes the calibration policies and labelling and security requirements for laboratory instruments and equipment.

Archiving Laboratory Documentation

This procedure describes the retention and disposal procedures of laboratory documentation. Generally, quality control laboratory documentation includes raw material and finished product test reports, specifications, certificate of analysis, sample register, GLP training, trend cards, procedures for long-term document retention, etc.

Management of Reference Substances

This SOP describes the ordering, referencing, storing, coding, use, and general register maintenance of primary and secondary reference standards.

Laboratory Workbook

This SOP describes the types of laboratory workbooks, the GMP requirements for using workbooks, analytical data entry in the workbook, and the formatting of laboratory workbooks for routine testing and trials.

Creation of Certificate of Analysis

This procedure defines the content and format of a Certificate of Analysis (C/A) and Certificate of Manufacture (C/C), provides guidance for issuing a C/A or C/C, and locates the appropriate data required for this task.

Managing Analytical Reagents

This SOP identifies the need for all analytical reagents and solutions prepared from the reagents to have an assigned expiration date and storage conditions recorded on the label.

Laboratory Waste Management

This simple procedure describes how to dispose of laboratory-generated wastes that are toxic, explosive, flammable, corrosive, oxidizing, and biologically damaging.

Retention Samples Management in Laboratory

This SOP describes the finished goods and raw material sample retention procedures, products manufactured and received onsite, and products chemically tested by the laboratory.

Laboratory Results Out of Specification Investigation

This procedure describes the actions an analyst will take if the result of a test does not conform to raw material/components or finished product specifications for physical and chemical tests. An out-of-specification (OOS) result does not necessarily mean the batch under investigation fails and shall be rejected.

Laboratory Testing and Documentation of Raw Materials

This SOP describes the procedure for sampling, location, pre-testing, testing, and documentation of all raw materials and components subject to testing, out-of-specification results, microbiological tests, and release procedures for passed raw materials and components.

Laboratory Testing and Documentation of Finished Products

This SOP describes the procedure for sampling, location, pre-testing, testing, and documentation of all finished products.

Preparation and Maintenance of Stability Protocols for pharmaceuticals Products

This procedure describes the preparation and management of Stability Protocols for marketed products.

Stability and Trial Testing Procedure for pharmaceuticals Products

This SOP describes the steps necessary to effectively control the stability program of new and existing pharmaceutical products and trial testing programs.

Preparation of Disinfectant Solution IPA

This procedure describes the preparation and use of disinfectant solutions (70% IPA) in the Sterile Area and also outlines the procedure for Integrity testing of the 70% IPA Filter.

Evaluation of Batch Documentation and Release for Sale

This procedure describes the process of collecting, evaluating, and recording batch-related documents generated during a batch’s production before an authorized person can release the batch for sale.

Laboratory Analytical Determinations

The purpose of this document is to describe the operational procedures to be followed when conducting analyses in the pharmaceutical quality control laboratory.

HPLC Reproducibility, Column Performance, and Testing Guidelines

The purpose of this document is to describe the reproducibility checks of the High-Performance Liquid Chromatograph, Column Performance, and guidelines for assay testing on the HPLC.

HPLC Method Development & Validation Procedure

The validation of an analytical method is the process by which it is established that the method’s performance characteristics, such as Precision, Accuracy, Specificity, Linearity, Limit of Detection (LOD), Limit of Quantitation (LOQ), and Robustness, meet the requirements for the intended applications.

Laboratory In Process and Finished Product Quality Control

This document outlines the procedure for receiving, scheduling, testing, reporting, reviewing, approving, and releasing in-process and finished Products in the pharmaceutical quality control Laboratory.

Laboratory Housekeeping and Glassware Cleaning

This document establishes laboratory housekeeping practices and glassware cleaning guidelines in the pharmaceutical Quality Control Laboratory.

Safety Procedure in Laboratory

This document outlines the procedure to provide a safe working environment in the Quality Control Laboratory.

Use and Control of Laboratory Chemical Materials

This document describes the requirements for receipt, labeling, handling, storage, standardization, and review of laboratory chemical materials in the Quality Control (QC) Laboratory.

Qualification of Laboratory Instruments

This SOP aims to outline the general system and documentation required to qualify laboratory instruments. This procedure also outlines post-service qualification requirements for HPLC systems.

Sampling of Raw Materials, In-process, and Bulk Finished Products

This SOP aims to outline the correct sampling technique for samples of raw materials, blends, end-of-run (EOR), coated, and bulk finished products and ensure that samples are representative of the batch of materials or products from which they are taken.

Stability Management Procedure

This document outlines the procedure to be followed to manage the stability program in the Quality Control Laboratory.

Validation of Analytical Test Procedure

This procedure defines the requirements for validating Non-Compendial Analytical and Biological Test Methods. The objective of the Validation / Verification is to demonstrate that the test methods are suitable for their intended purpose.

1.4 Microbiology (Sterile) Laboratory Procedures SOP

Entry Procedure for Sterile Filling Areas

This SOP outlines the gowning procedure that must be followed by every person who enters a Sterile Area.

Validation of Aseptic Gowning Procedures

This SOP outlines the sterile gowning validation procedure required for the final sign-off on the initial sterile training and the revalidation of currently trained Operators, Fitters, Electricians, cleaners, and all organization staff authorized to enter Sterile areas.

Microbiological Data Recording Procedure

This SOP describes the method for recording microbiological data using the in-house hard copy and computerized recording system.

Depyrogenation of Glassware in Microbiology Laboratory Oven

To outline the procedure for the depyrogenation of glassware using the Microbiology Laboratory Qualtex Oven.

Media Preparation in Microbiology Laboratory

This SOP describes the procedure for preparing microbiological media for the Microbiology Laboratory.

Aseptic Media Filling and Microbiology Integrity Leak (Soup) Testing Procedure

This SOP outlines the procedures for Media Fills and Microbiological Leak Tests. For validation purposes, a microbiological leak test (soup test) or a separate protocol to verify the entire process from the ‘bioburden reduction filter’ to the primary container may be required.

Aseptic Media Filling and Soup Test Guideline

Media fills are designed to verify the entire process, equipment, and staff. This process simulation should be performed as initial validation with three (3) consecutive satisfactory simulation tests per shift and repeated at defined six monthly intervals (twice per year per process per shift) and after any significant modification to the HVAC system, equipment, process, and number of shifts” for aseptically filled processes.

Environmental and Plant Hygiene Monitoring Procedure

Description for microbiological testing of areas of the environment that may influence or affect product performance and quality, including air, surfaces, personnel, clothing, and disinfectants.

Microbial Limit Testing Procedure Using Laminar Flow Cabinets

This SOP describes the procedure for conducting Microbial Limit Tests in the Microbiology Lab’s Laminated flow Cabinets.

Microbiological Monitoring of Plant Water Systems

In this SOP, you will find the sampling procedure for bioburden and endotoxin samples, bioburden test method and results, endotoxin testing of WFI (distilled water), alert and action levels, diagrammatic representations of a typical purified water system, bioburden waste tank water sampling, clean steam sampling & testing, OOL/OOS Result Actions, etc.

Micro Laboratory Procedure for Sterility Testing

This sop describes the procedure for sterility testing of aqueous, injectable, and terminally sterilized non-injectable products.

Determination of Heat Resistance of Spore Forming Organisms

This SOP describes the method for calculating spore-forming organisms’ Heat Resistance Factor (D-value). D-Value is defined as the time required for a population of a pure culture of microorganisms to be decreased by 90% when exposed to a fixed temperature, e.g., 121°C (+1°C).

Identification of Microorganisms to Genus and Species Level

This SOP describes the procedures for the preliminary identification of microorganisms isolated from plant water, environmental, personnel, product, and raw material sources.

Micro Evaluation on Bioburden, Non-sterile, and Raw Materials

This SOP describes the procedures for microbiological evaluation of bioburdens, non-sterile products & raw materials.

Bacterial Endotoxin Testing (LAL) – Gel Clot Method

This SOP describes the process for conducting a bacterial endotoxin test using the LAL Gel-Clot method.

Bacterial EndoToxin Testing kCA Method

This SOP aims to outline the theory of Bacterial Endotoxin testing using Kinetic Chromogenic Analysis (KCA).

Stock Suspensions of Microorganisms

This SOP describes the method for preparing and maintaining stock suspensions of vegetative microorganisms and spores used in the Microbiology Laboratory.

Sterile Sampling Procedure for Microbiology Laboratory

This SOP describes the process of taking microbiological samples for sterility testing, bacterial endotoxin testing, bioassay testing, microbial limit testing, and microorganism control in pharmaceutical production.

Gel Clot Validation Method

This SOP describes the gel clot validation method for bacterial endotoxin testing. Gel clot validation is required to determine the level of inhibition/enhancement of products on the Lal test for endotoxins within the allowable maximum valid dilution (MVD) for each product type.

Laboratory Investigation and Retest Procedure for Atypical and Out-of-Specification Results

This procedure provides guidance when investigating microbiology laboratory out-of-specification (OOS) results associated with raw material samples, in-process samples, and finished product samples. Retesting should be viewed as an investigational tool to aid in determining the Root Cause Analysis of the discrepant laboratory result.

Operation and Calibration of Sievers 820 TOC Analyser

To define the procedures to be followed and the responsibility for the operation, calibration, and maintenance of the Sievers 820 TOC Analyser with Autosampler.

IPA Contamination Testing Procedure

To describe the test sometimes used to check the purity of the IPA used in the factory as a disinfectant.

Control of Microbiology Test Methods

This SOP details the writing, control, and distribution of Microbiological Test Methods (MTM) for use in the GMP Microbiology Lab.

Handling of Test Samples in Microbiology Laboratory

This document details how to handle test samples (raw materials, bulk products, and stability samples) processed for microbial limits testing (MLT) in the microbiology laboratory.

Documentation Requirement For Micro Test Method Validation

The SOP describes the process of accessing and using protocol templates to document test method validation activities in microbiology laboratories.

Maintenance of Culture Collection

This SOP deals with the correct means of maintaining a culture collection, emphasizing aseptic practices in the laboratory.

Choice of Effective Sanitizing Agents for Microbiology Laboratory

This standard operating procedure outlines the criteria and rationale for selecting sanitizing agents, their quality control, and the documentation required.

Initial Investigation of Out of Specification (OOS) Results in Microbiological-Laboratory

This SOP aims to establish a procedure for investigating initial out-of-specification (OOS) or questionable results generated for the product or material being tested in the microbiology laboratory.

Good laboratory practices (GLP) for microbiology and chemistry laboratories

This standard operating procedure describes good laboratory practices employed in the QC microbiology and chemistry laboratories.

Handling of media diluents and reagents in the Microbiology Laboratory

This SOP describes the general procedure for the receiver, use, and storage of all media, diluents, and reagents in the Microbiology Laboratory at a GMP site.

1.5 Standard Operating Procedure for Packaging Operation

Clothing Requirements Inside the Factory Area

This SOP covers the clothing requirements for your manufacturing site in all factory areas.

Cleaning Responsibilities and Methods for Employees

This SOP describes the cleaning procedures to be followed by all manufacturing employees to prevent product contamination by foreign materials from another batch or by dirty parts that may contain bacteria.

Factory Cleaning Procedure

This SOP defines factory cleaning and record-keeping methods, frequency, and intensity.

Manufacturing Pest Control Procedure

This SOP describes the responsibilities of all employees and pest control services, the classification of pests, the frequency of the pest control service, and effective treatments against all types of pests.

Management of Production Logbook

This procedure outlines the generation, maintenance, and filing of Production logbooks.

Examples of Packaging Configuration for Production Line

This SOP provides an alphabetically indexed diagram of shipper packing and pallet packing configurations for any packaging process.

Checking of Components Before Use

This SOP sets out a procedure to ensure that only components of the correct code and batch number are issued for a batch and that only issued components will be used in a finished product batch.

Safety Tag Out Procedure

This SOP describes how to prevent the risk of personal injury or damage to equipment likely to be caused by operating or attempting to operate machinery or equipment diagnosed as unsafe, in need of repair or maintenance, or formally removed from service.

Procedures for Line Clearance, Line Opening, and Line Cleaning

This SOP describes the procedure and order for performing line clearance, opening, and cleaning in batch production.

Reconciliation Procedure of Component and Product

This simple SOP describes the concept of reconciliation, how to reconcile finished goods, and determine the allowable discrepancies between components and products when reconciled.

Example of Intermediate Bulk Containers Operation and Cleaning

This SOP describes the operation and cleaning procedures for using the Intermediate Bulk Containers (IBCs) to store bulk tablets on the process line.

Example of a Tablet Packing Machine -Construction, Operation and Cleaning

This SOP describes the procedure for sampling, location, pre-testing, testing, and documentation of all finished products subject to test, reagents, and standards to be used for analysis, management of out-of-specification results, microbiological tests, and release procedures for passed finished goods.

Example of Manufacturing and Packaging Instructions for Tablet Packing

This SOP describes creating complete manufacturing instructions for your process line to be followed by your manufacturing employees.

Scheduling of Production Lines

This procedure describes how to produce a monthly manufacturing schedule following an agreed 12-month plan to provide a sequence of work that will enable the scheduling of support groups, i.e., quality, technical, and warehousing.

Vacuum Leak Testing Procedure for Finished Goods

This SOP describes the set-up and operation of a standard vacuum leak tester for the popular vacuum leak testing used in a typical packing line.

Weighing Equipment – Checking and Calibration

This paper outlines the procedures required for checking/calibrating and repairing balances, scales, check-weighers, and load cells.

Example of Operation of Automatic Checkweigher for Finished Packs

This SOP describes the set-up and operating procedures for the Check weigher in the packing lines.

Example of Tablet Packing – Start-up and In-process Testing

This procedure contains instructions that enable the production operators working in a typical packing line to carry out start-up and in-process tests required to produce quality products and to ensure in-process controls.

Example-Packed Tablet Sampling by Production Personnel for Testing

This procedure describes the process of sampling manufactured finished goods required to be taken by production personnel for laboratory testing. A typical tablet packing process is used here as an example.

Component Return Procedure from Packaging Floor

This procedure describes the steps to follow when packaging components are to be returned to the warehouse after the packaging operation is completed.

240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Additional documents are included each month. All are written and updated by GMP experts. Checkout sample previews. Access to exclusive content for an affordable fee.

1.6 Warehouse Management Procedures SOP

Generation of Purchase Order for Inventory and Consumables

This procedure describes the steps to be followed by the planning and procurement department to create purchase orders for inventory items to be purchased from overseas and local suppliers.

Procedure for Receipt of Incoming Goods

This SOP contains step-by-step instructions on accepting incoming goods in the warehouse, the ‘booking In’ procedure for component and non-component goods, and how to complete movements of incoming goods into different storage locations within the warehouse, maintaining full traceability. You will also find the generation and filing of documents related to receiving incoming goods and material handling in the warehouse.

Incoming Raw Materials and Components-Handling by QC Sampler

This procedure describes quarantining, sampling, testing, and releasing incoming raw materials to Production.

Warehouse Processing Issues, Returns and Rejects

This SOP contains step-by-step instructions on the issue of tested and QC-released components for batch production and documentation needed to capture identification and traceability information during the picking, assembling, and transferring of those components from the warehouse to production.

Dispatch of Goods from Warehouse

This SOP contains instructions and documentation on the movement of finished goods to quarantine until release for sale, the dispatching procedure, and documentation needed for transferring finished goods from quarantine to the warehouse store and subsequently to outside the manufacturing site, maintaining complete traceability of finished goods.

Warehouse Inventory Management Procedure

This procedure provides a complete inventory management system with stock counting instructions, stock classification, and reconciliation programs.

Design of Warehouse Locations and Storage Area

This SOP is designed to understand and draw a schematic diagram of ideal warehouse and production areas, identifying in-coming goods storage unit types and storage bin types, quarantines, reject cages, cool rooms, flammable storage, dispensary booths, production areas, finished goods quarantine area and finished goods storage areas.

Finished Goods Transfer to Quarantine and Distribution Warehouse

This simple SOP contains instructions and documentation on the movement of finished goods from production to the warehouse finished goods quarantine location until the samples are tested and released by authorized persons.

Sampling Procedure of Raw Materials

This procedure is primarily concerned with the risk associated with sampling, precautions to be followed, general sampling procedures for raw materials, critical and non-critical components, chemicals, and secondary reference standards for the laboratory.

Sampling of Components and Printed Materials

This procedure is an elaboration of SOP WAR-045 and is mainly concerned with sampling plans and instructions for components and printed materials for quality testing before release for production use.

Safety Procedure of Warehouse Racking

This SOP outlines the measures to ensure the safety of all goods and personnel when using the storage racking system to avoid injury to staff or damage to property.

Forklift Operation in Warehouse

This SOP gives instructions on the operation requirements and maintenance of forklifts used in the warehouse and on safety precautions to be taken when operating forklifts under load.

Tablet Dispensary Procedure

This procedure mainly concerns dispensing plans and instructions for released raw materials for production use. An example of a tablet dispensary procedure is prepared to better explain and understand dispensing. You will be able to follow the instructions for dispensing any raw materials during the cleaning of the pharmaceutical factory.

Example of Raw Material Tablet Sampling by Dispensary

This SOP explains the raw material bulk tablet sampling procedure in the Dispensary.

Sampling and Inspection of Raw and Bulk Materials

This SOP describes the procedure for inspecting and sampling receipted raw materials (RM), bulk materials (BM), or Semi-Finished goods (e.g., tablets, pastes, capsules) and active pharmaceutical ingredients (API).

Sampling Inspection and Release of Packaging Materials

This procedure explains how to sample, inspect, and release packaging materials (except roll feed labels) into the Packaging Store Area. It is critical to GMP.

Status Labels

This standard operating procedure aims to define the meaning of the status labels used at GMP sites.

A sampling of Raw Materials in Sampling Booth

To outline acceptable sampling booth operating parameters and required actions before, during, and after completion of sampling of raw materials in the receiving area sampling booth at the GMP site.

Cleaning of Sampling Booths and Implements in the Raw Materials Quarantine Store

This procedure outlines cleaning the sampling booth in the receiving quarantine area at the GMP site.

Classification of Defects for Incoming Packaging Components

Defines the classification of defects found during the inspection of incoming packaging components.

Storage or Handling Rules for Inventory Items

To outline procedures for storage and handling inventory items in the Warehouse at a GMP site. Non-inventory items and consumables of importance are also covered.

1.7 Environmental Health and Safety Procedures SOP

Hazardous Chemical Substance Management

This SOP describes the requirements for managing approval for proposed new chemical substances.

Environmental, Health and Safety Risk Management

This SOP describes the risk management process of identifying EHS hazards, assessing risk, designing appropriate controls, and reviewing the controls.

Waste Removal Process

To standardize the types of containers used for handling all types of waste, recycling material, and waste from the Manufacturing facilities.

EHS Incident Management Procedure

This procedure defines the requirements for immediate action, investigation, reporting, corrective and preventive action, follow-up, and training associated with EHS incidents.

First Aid Procedure

This SOP formalizes the role of the nominated site first aiders, clarifies their responsibilities, and provides them with information about the delivery of first aid.

Blood and Body Fluid Spill Management

This SOP provides information and guidelines for managing blood and body fluid spills due to an accident.

Blood-Borne Pathogen Exposure

This SOP provides information and guidelines for managing exposure to blood-borne pathogens in the workplace.

Building Cleaning Procedure

This SOP provides an overview of the procedures used for the contract cleaning and sanitation of the GMP building, engineering shed, and demountable buildings.

Environmental Management System Plan

This SOP details the environmental management system (EMS) that ensures the GMP plant complies with the in-house environmental guidelines and local, state, and national government regulatory requirements and has an ongoing improvement plan for environmental performance.

Environmental Aspect Register

Fire Protection Impairment Handling

This SOP details the procedure for notifying the GMP site’s insurers of any intended impairment of the installed ‘Fire Equipment’ on site.

Hot Work Permit Procedure

This SOP covers all aspects of hot work activity at the GMP facility. Hot work refers to any work that produces or has the potential to produce a spark or open flame, including oxy and electric welding.

Hazard Identification and Incident Investigation Reports

This document defines the procedure for identifying, investigating, and reporting hazards, near misses, and accidents.

First Aid Procedure

This SOP aims to define the first-aid procedure for the GMP site. The first-aid procedure shall encompass the responsibilities and actions required for first-aid treatment.

Industrial Hygiene Sampling for Airborne Contaminants

Sampling must be performed with a calibrated sampling pump. Calibrations must be performed before and after sampling for each sampling pump, with the sampling media (filter cassette or sorbent tube) in line.

General Security Procedure for GMP Manufacturing Area

The site security team ensures a high level of awareness amongst all staff of security measures implemented for general site access and the manufacturing building. This is critical not only for our customers and our integrity as a supplier of prescription medicines but also for continued compliance with the conditions of our licenses to manufacture, import, and export Pharmaceutical products.

Occupational Medical Support Procedure for a GMP Site

This SOP aims to provide all existing and potential colleagues with the information they need to comply with the procedures for preventative occupational medical evaluation and control in compliance with local requirements and EHS guidelines.

Pharmaceuticals Pest Control Procedure

The pest control procedure is designed to act as a control and preventative maintenance program against insect and rodent infestation in buildings at the GMP site.

Personal Protective Equipment (PPE) Policy for a GMP Manufacturing Site

This SOP provides information and guidelines for the supply and purchase of personal protective equipment (PPE).

Environmental Health and Safety Training

The requirements outlined in this SOP are to be completed by all colleagues at the GMP site. Where explicitly stated, all personnel on-site will need to complete some of the requirements in this procedure.

Laboratory Spill Response

This SOP provides guidance and instruction on managing chemical spills in a laboratory environment.

Process Safety

This procedure ensures that hazards that can potentially cause acute catastrophic events, such as accidental chemical releases, fires, and explosions, are identified, assessed, and adequately controlled.

Industrial Hygiene Sampling

This SOP guides a uniform methodology for workplace sampling of personal exposures and engineering performance validation.

Selection of Personal Protective Equipment (PPE)

Risk assessment will be conducted in all work areas and for all tasks to identify the requirements for personal protective equipment.

Environmental Health and Safety Risk Assessment Methodology

In a GMP environment, a risk-based approach must be used to evaluate the hazards and controls used to mitigate them. Hence, risk assessments are essential to ensure that all hazards in a plant are identified and controlled if the risk associated with them is unacceptable.

2.0 GMP Audit Training Manuals

Auditing Principles for GMP Audit

This manual will help you understand the use of auditing components while performing a GMP Audit and how to use a range of information tools in support of one. Develop and communicate a complete audit agenda to audit team members and the audited area.

Understanding Worldwide Regulatory Requirements

Determine the appropriate international regulatory requirements of a GMP site or product being audited. Identify which regulatory agencies govern specific regions of the world. Use various information tools to support a manufactured product distributed and sold worldwide.

Personnel & Training System Audit

This module will help you audit a personnel and training system. It will help you understand which worldwide requirements apply to personnel and training and use a range of information tools, including this module, to support an audit.

Deviation Management System Audit

Perform an audit of a deviation management system. Use a range of tools and information, including the contents of this unit, to support the audit of a deviation management system.

Validation System Audit

Perform an audit of a validation of facility and utility (excluding computer systems). Use a range of tools and information, including the contents of this module, to support the audit of a validation system.

Change Management System Audit

Perform an audit of a change control management system. Use a range of tools and information, including the contents of this unit, to support the audit of a change management system.

Complaint System Audit

Perform an internal, supplier, or contractor audit of a complaint system. Familiarise yourself with which of the worldwide requirements apply to managing complaints.

Documentation System Audit

This module will help you conduct an audit on good documentation practice. Understand and apply appropriate GMP standards/regulations to audit a documentation system. Recognize compliance or non-compliance of documentation systems to applicable regulations.

Calibration, Preventative Maintenance & Housekeeping System Audit

Perform an audit of calibration, preventive maintenance, and GMP housekeeping practices. Understand and apply appropriate GMP regulations while auditing a calibration, preventive maintenance, and housekeeping system.

Computerized Systems Audit

This module will help you how to identify if a computer system validation is required. Use the technique to measure GMP implications of the computer systems. Include in the audit an assessment of the computerized systems used to support a GMP facility.

Utility Systems Audit

You will find the proper technique for auditing a site utilities system. Understand and apply GMP standards while auditing the utility system. Identify compliance or non-compliance of a utility system with applicable regulations.

Warehouse and Distribution System Audit

This module will guide you in conducting a warehouse audit. Understand warehousing and distribution requirements for GMP facility, including licensing requirements. Understand and apply applicable GMP standards while conducting an audit.

Environmental Monitoring System Audit

Understand how to conduct an environmental monitoring audit. Apply worldwide regulatory agency requirements to environmental monitoring. Identify noncompliance and apply corrective actions to strengthen your processing environment.

Microbiology and Sterility Testing Laboratory Audit

Understand what the GMP requirements are for microbiological and sterility testing laboratories. Use the information, tools, and techniques from this training module to recognize the noncompliance of microbiology and sterility testing laboratories.

Analytical Quality & Stability Testing Laboratory Audit

Understand the GMP requirements for the analytical quality laboratory and stability testing laboratory.

Material Handling System Audit

This module will help you audit the warehouse material handling system. Understand and apply appropriate GMP standards/regulations to an audit of a warehouse material handling system.

Active API Manufacturer Audit

Perform an audit of an active pharmaceutical ingredient (API) manufacturer. Understand and apply applicable GMP standards to an audit of an API manufacturer.

Packaging Material Supplier Audit

This module will help you understand packaging materials and how to perform a supplier audit. It will also help you understand which worldwide requirements apply to packaging component suppliers.

Packaging and Labeling Operation Audit

This module will help you conduct a packaging and labeling audit. It provides a range of information tools to support this process.

Aseptic Sterile Area Audit

Perform an audit of an aseptic filling room and processing area. Access and understand aseptic/sterile manufacturing requirements. Understand worldwide regulatory agency requirements for aseptic/sterile processing.

Excipient Supplier Audit

Perform an audit of an excipient vendor. Understand and apply applicable GMP and site standards to an audit of an excipient vendor.

Oral Solid Solution Area Audit

Apply the regulatory requirements related to oral dosage forms. Use the techniques provided in this module to perform an audit of oral dosage.

240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Additional documents are included each month. All are written and updated by GMP experts. Checkout sample previews. Access to exclusive content for an affordable fee.

3.0 Quality and Validation Manuals

3.1 Quality Manuals

Evaluation of Contaminant Options for Packing of Solid Dosage Forms. (same as QMS MANUAL- 003)

This guideline is designed to assist in making decisions on appropriately accommodating the packing of solid dosage forms, from bulk-packed tablet products to finished packs for shipping.

Retention and Disposal of GMP Documents and Retention Samples. (same as QMS MANUAL- 005)

This procedure describes the minimum requirements for retaining samples and documents under GMP and Medical Device regulations/legislation.

Certificate of Materials Supplied to Manufacturing Site (same as QMS MANUAL- 007)

This guideline defines the processes for certifying materials provided by suppliers, including the requirements for maintaining them in a “certified“ status.

Quality Assurance Agreements. (same as QMS MANUAL- 010)

The purpose of this Guideline is to define the general requirements and provide guidance for quality agreements for the development, manufacture, testing, storage, and distribution of intermediates, active pharmaceutical ingredients, and investigational products destined for use in pre-clinical, clinical, and other Research and Development studies.

Procedure for Quality Assurance Management of Contractors. (same as QMS MANUAL- 011)

The purpose of this procedure is to describe the requirements for the quality management of contractors, to describe the role of contract giver sites in this context, and to provide a model for the development of Quality Assurance Agreements with Contractors.

Guidelines for Regulatory Inspections. (same as QMS MANUAL- 017)

To provide the minimum mandatory requirements for notification, conduct, reporting, and follow-up action associated with inspections by regulatory authorities and outline recommendations for achieving compliance.

Quality and Compliance Auditing. (same as QMS MANUAL- 018)

This guideline defines the quality and compliance auditing concept within the quality management system and outlines the roles and responsibilities for planning, performing, reporting, and following audits.

Auditor Training. (same as QMS MANUAL- 014)

To provide minimum mandatory requirements and outline best practices for ensuring that company auditors have a common baseline of training and experience to carry out GMP quality and compliance audits of suppliers and internal audits.

GMP Compliance Improvements Plans. (same as QMS MANUAL- 029)

The purpose of this document is to provide some requirements and recommendations for the development, content, and management of compliance improvement plans (CIPs).

Archiving, Disposal, and Record Management. (same as QMS MANUAL- 030)

The purpose of this document is to provide management and technical personnel with requirements as well as guidance on the archiving, records keeping and management, and disposal of data and information.

Internal Quality Assurance Agreements. (same as QMS MANUAL- 044)

The purpose of this procedure is to describe the process for a Quality Assurance (QA) Agreement regarding the supply of active pharmaceutical ingredients, bulk-formulated products, part-finished packs, and finished packs to be followed by a pharmaceutical operation.

Audit of a Distribution Site. (same as QMS MANUAL- 045)

This procedure defines how to perform distribution site audits and includes selecting, preparing for, conducting, reporting, documenting, and archiving them.

Supplier Auditing of GMP Facility Guidelines. (same as QMS MANUAL- 046)

This manual guides assigning the lead audit team’s responsibilities, establishing an external supplier’s audit program, and the high-level principles involved in conducting supplier audits.

Management of Master GMP Document. (same as QMS MANUAL- 047)

The purpose of this guideline is to provide the regulatory requirements for the management of master GMP documents issued, controlled, and used to verify compliance with required GMP codes and other relevant quality and compliance standards. Recommendations on how to achieve compliance are also included.

Artwork Creation & Control of Printed Packaging Components. (same as QMS MANUAL- 048)

This guideline describes how artwork and printed package components should be created and controlled.

Release of API Bulk Formulated Products & Part Finished Packs. (same as QMS MANUAL- 049)

The purpose of this guideline is to define the requirements for the assessment of data and documentation before release.

Computerized Systems Risk Management. (same as QMS MANUAL- 050)

To define the requirements for applying risk management principles to computerized systems.

Batch Confirmation Certification & Release by a Qualified Person. (same as QMS MANUAL- 056)

This procedure describes the accountabilities and single process for batch confirmation, certification, and release by a Qualified Person (QP) within the European Union (EU).

Cross Contamination Risk Evaluation Process for Commercial Compounds. (same as QMS MANUAL- 057)

This guideline describes the process for ensuring that drug products and drug substances are manufactured in a manner that minimizes patient risk through adulteration from products manufactured in the same manufacturing equipment and facility cleaning.

Certificate of Analysis & Certificate of Manufacture. (same as QMS MANUAL- 062)

This guideline defines the content of Batch Specific Documentation (BSD), the process by which it is produced, and its use. In this context, BSD refers to the Certificate of Analysis (C of A) and the Certificate of Manufacture (C of M).

Annual Product Quality Reviews. (same as QMS MANUAL- 022)

The purpose of this guideline is to provide requirements for the content, scope, and procedures for developing annual product quality reviews and outline recommendations for achieving compliance.

Warehousing and Distribution of Commercial Products. (same as QMS MANUAL- 024)

The purpose of this guideline is to guide the warehousing and distribution of commercial products.

Utility Standards. (same as QMS MANUAL- 033)

This guideline provides guidance on the design and specification of utilities associated with the manufacture, quality control, and storage of API, intermediates, and investigational products within an R&D facility.

Conducting Investigations. (same as QMS MANUAL- 034)

To provide requirements in addition to recommendations for the performance of investigations in response to an incident, problem, or deviation that may affect the safety, identity, strength, purity, or quality of an active pharmaceutical ingredient (API) or drug product.

Management and Documentation of Training. (same as QMS MANUAL- 037)

To provide requirements for management and documentation of training and outline recommendations on how the requirements can be met.

Definition and Documentation of Raw Data. (same as QMS MANUAL- 038)

The purpose of this guideline is to provide requirements for the definition and documentation of raw data and outline recommendations for achieving compliance.

Risk Management in the Quality Assurance and Compliance Area. (same as QMS MANUAL- 041)

This document provides guidance on a process for risk identification, assessment, control, and review in the area of GxP-regulated quality and compliance.

Manufacturing Deviation Management. (same as QMS MANUAL- 052)

This guideline aims to outline the requirements for reporting, investigating, and handling individual deviations and to outline a systematic approach for trending deviations to enable ongoing improvement in deviation performance.

Study-Based GLP QA Audit for Critical Phases. (same as QMS MANUAL- 053)

To define the process for the frequency and audit of critical phases within a non-clinical safety study. This procedure may apply to all R&D GLP QA staff. It will be used in compiling a program to identify audits for non-clinical safety studies and study parts for which compliance with GLP is claimed.

Guideline for Development and Contents of Specifications. (same as QMS MANUAL- 060)

This guideline describes the process for generating, approving, and managing specifications within R&D for the release of materials used in clinical trials during drug development.

Manufacture, Packing, and Shipping of Materials Ahead of Full QA Clearance. (same as QMS MANUAL- 064)

This International Procedure aims to describe the manufacturing, packing, and shipping of material ahead of clearance.

Determination of Storage Periods for APIs, Excipients, Intermediates, and Raw Materials. (same as QMS MANUAL- 065)

This Procedure aims to define the requirements for retesting and assigning storage periods for APIs, excipients, intermediates, and raw materials.

Guidelines for Generating Manufacturing Documentations. (same as MFG MANUAL – 003)

This document provides guidelines for documenting the commercial manufacture and packaging of Active Pharmaceutical Ingredients (APIs) and formulated drug products.

Electronic Records and Electronic Signatures. (same as QMS MANUAL- 067)

The purpose of this document is to provide an interpretation of FDA 21 CFR Part 11, Electronic Records; Electronic Signatures (ER/ES), and to provide guidance for acceptable practices in the use of electronic records and electronic signatures by any site.

3.2 Validation Manuals

The Preparation of Process Validation Master Plan. (same as VAL MANUAL- 001)

This procedure covers the planning of validation activities related to the manufacturing and control of the registered stages of the Drug Product or active pharmaceutical ingredient (API) for clinical use, validation, or sale.

Process Validation of Bulk Drug (API and Intermediate). (same as VAL MANUAL- 005)

This document guides validating processes for manufacturing bulk drugs, i.e., those synthetic stages from the introduction of the defined API Starting Materials into the process, including the physical processing of the API.

Process Validation for Formulated Products. (same as VAL MANUAL- 009)

The purpose of this document is to provide minimum mandatory requirements in the validation of processes for the commercial manufacture of formulated products to demonstrate the effectiveness and reproducibility of a process and its suitability for the intended purpose.

Cleaning and Cleaning Validation of API Plant and Equipment. (same as VAL MANUAL- 013)

This guideline defines the requirements for cleaning plants and equipment manufacturing active pharmaceutical ingredients (APIs) or their intermediates.

Sterilization Process Validation. (same as VAL MANUAL- 016)

To provide guidelines for the validation of sterilization processes used in the manufacturing activities for drug products or active pharmaceutical ingredients (API) and outline recommendations on how to achieve compliance.

Cleaning and Cleaning Validation for Formulated Products. (same as VAL MANUAL- 019)

This guideline defines the minimum requirements for cleaning and validation of cleaning processes for formulated products.

General Outline of Analytical Procedure Validation. (same as VAL MANUAL- 024)

This guideline aims to outline the content and approval process for analytical procedures and describe those activities that should be carried out to demonstrate that analytical procedures used in laboratories within R&D and manufacturing operations are suitable for their intended purpose.

The Validation of Facilities and Systems. (same as VAL MANUAL- 028)

The purpose of this guideline is to provide requirements for the Validation of Facilities and Systems and to outline recommendations on how to achieve compliance.

Information Technology Infrastructure Qualification. (same as VAL MANUAL- 036)

This manual guides the qualification requirements for the Information Technology infrastructure.

Management of Change in Computerized System. (same as VAL MANUAL- 040)

The purpose of this guideline is to define and provide guidance on the requirements for managing and documenting changes that take place during the development, implementation, or operation of a computerized system, including its supporting operating environment.

Access by Regulatory Authorities and Auditors to Electronic Records. (same as VAL MANUAL- 045)

This guideline advises you on the practices to be adopted when you wish or request to display or provide copies of electronic records to regulatory authorities, auditors, and other similar third parties.

Technology Transfer of Established Medicine from One. (same as VAL MANUAL- 031)

To describe a process for the transfer of manufacturing of an established drug product from one established commercial manufacturing site to additional/alternative sites. This includes the associated quality control processes, health safety, and environmental information.

240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Additional documents are included each month. All are written and updated by GMP experts. Checkout sample previews. Access to exclusive content for an affordable fee.

3.3 - Laboratory Operations Manuals

Water Quality Standard. (same as LAB MANUAL – 003)

This procedure describes the quality standards required for producing, distributing, using, and testing water used to manufacture manufactured materials.

Sterility Testing Procedure. (same as LAB MANUAL – 005)

This guideline aims to provide a general guideline for sterility testing. This guideline should ensure that the products manufactured meet the appropriate regulatory and company requirements.

Endotoxin Testing Procedure. (same as LAB MANUAL – 006)

This guideline aims to ensure that the products manufactured meet the appropriate regulatory and company requirements for endotoxin testing.

Guideline for Stability Testing for R&D. (same as LAB MANUAL – 007)

The purpose of this document is to provide recommendations for performing and documenting stability studies within R&D.

Storage and Expiry Dating of Analytical Reagents in Laboratory. (same as LAB MANUAL – 009)

This guideline outlines the requirements for the expiration dating of all analytical reagents and solutions prepared from these reagents. Recommendations on how to achieve compliance are also included.

Preparation & Maintenance of Stability Protocols and Stability Master Plans. (same as LAB MANUAL – 010)

This guideline defines the minimum requirements for cleaning and validation of cleaning processes for formulated products. It also covers post-validation monitoring of cleaning process effectiveness.

Commercial Stability Testing of API (Pure Bulk Drug). (same as LAB MANUAL – 012)

This procedure intends to teach the principles of a stability program to the active pharmaceutical ingredient (API) manufacturing sites.

Commercial Stability Studies at Contractors. (same as LAB MANUAL – 013)

This procedure aims to describe how stability studies carried out by contractors shall be managed.

Microbiological Testing for Non-Sterile Drug Product. (same as LAB MANUAL – 016)

The purpose of this guideline is to guide the microbiological testing of non-sterile products.

Reference & Retention Samples. (same as LAB MANUAL – 017)

The purpose of this guideline is to describe the requirements for the sampling and storing reference and retention of samples under GMP regulations/legislation.

Laboratory Equipment Qualification. (same as LAB MANUAL – 018)

The purpose of this guideline is to demonstrate the qualification of laboratory equipment within R&D.

Manufacture and Microbiological Testing of Sterile API & Drug products within R&D. (same as LAB MANUAL – 020)

This manual guides the manufacture and microbiological testing of sterile Investigational Medicinal Products (IMP) and Active Pharmaceutical Ingredients (API).

Commercial Stability Testing For Formulated Products. (same as LAB MANUAL – 022)

This procedure aims to teach manufacturing and primary packaging sites the principles of a stability program.

Environmental Monitoring. (same as LAB MANUAL – 001)

The purpose of this guideline is to provide requirements for environmental monitoring. This guideline provides recommendations on how to achieve compliance with the requirements.

The purpose of this international guideline is to outline minimum mandatory requirements and recommendations for identifying and reacting to trends found in stability data.

Laboratory Out of Specifications Results Investigation Procedure. (same as LAB MANUAL – 026)

This manual guides the investigation and response to Out of Specification (OOS) laboratory test results.

Analytical Laboratory Procedures and Validation. (same as LAB MANUAL- 027)

This guideline aims to outline the content and approval process for analytical procedures and describe those activities that should be carried out to demonstrate that the analytical procedures used in GMP laboratories suit their intended purpose.

3.4 - Manufacturing Operations Manuals

Manufacturing Documentation. (same as MFG MANUAL – 003)

This document provides guidelines for how the commercial manufacture and packaging of active pharmaceutical ingredients (API) and formulated drug products should be documented.

Maintenance and Calibration of GMP Critical Items in Manufacturing Operations. (same as MFG MANUAL – 007)

This guideline defines the general requirements and provides guidance for the calibration and maintenance of instruments, equipment, facilities, utilities/services, and systems.

Re-treatment and Blending of API & Formulated Product. (same as MFG MANUAL – 014)

This guideline guides the reworking, reprocessing, or recovery (salvaging) of formulated products, APIs, and intermediates.

In-process testing, Checks, and Sampling. (same as MFG MANUAL – 018)

The purpose of this international guideline is to describe the requirements for in-process testing and sampling during manufacture and packing.

Management of Returned Goods. (same as MFG MANUAL – 022)

The purpose of this international guideline is to describe the principle of handling the quality assessment and recovery of returned goods.

Receipt Handling and Storage of Starting & Packaging Materials. (same as MFG MANUAL – 024)

The purpose of this guideline is to describe the receipt, handling, and storage of starting and packaging materials. The handling also includes sampling.

Control of Packaging Operation. (same as MFG MANUAL – 026)

The purpose of this guideline is to describe how packaging operations should be conducted.

Requirements of Facilities for Sterile and Non-Sterile Drug Manufacturing. (same as MFG MANUAL – 028)

This guideline describes the requirements for meeting current Good Manufacturing Practice (cGMP) compliance for new and upgraded facilities used to manufacture any sterile or non-sterile product.

Labelling and Packaging of Investigational Medicinal Products and APIs. (same as MFG MANUAL – 031)

This guideline’s purpose is to guide the GMP requirements for the labeling and packaging of investigational materials at all stages of manufacturing and packaging.

Principles and Responsibilities for The Management of Change in Manufacturing Operations. (same as MFG MANUAL – 034)

This procedure aims to define the principles for managing change within Operations. This document may apply to the change control management process, regulatory affairs, CMC, and all cGMP activities performed at operation sites.

4.0 Good Manufacturing Practice

240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Additional documents are included each month. All are written and updated by GMP experts. Checkout sample previews. Access to exclusive content for an affordable fee.

5.0 GMP Quality and Validation Guidance

5.1 GMP Validation Guidance

5.1.1 - Method Validation

Analytical Test Method Validation – General Guidance. (same as VAL MANUAL- 021)

Analytical Test Method Validation – Risk Assessment and Prioritization. (same as VAL MANUAL- 021)

Analytical Test Method Validation – System Suitability. (same as VAL MANUAL- 021)

Analytical Test Method Validation – Precision and Accuracy. (same as VAL MANUAL- 021)

Analytical Test Method Validation – Quantitation and Detection Limit. (same as VAL MANUAL- 021)

Analytical Test Method Validation – Linearity, Range and Specificity. (same as VAL MANUAL- 021)

Analytical Test Method Validation – Robustness. (same as VAL MANUAL- 021)

These guidelines, in combination, provide guidance for the validation of analytical test methods. These analytical test methods include those tests that evaluate API, Raw Materials, Process samples (e.g. reaction monitoring) and early intermediate materials (before introducing the first critical intermediate).

5.1.2 - Cleaning Validation

Cleaning validation – calculations of residue limits for drug products for equipment cleaning. (same as VAL MANUAL- 053)

The maximum allowable residue for therapeutics (MART) and residue acceptability limit for therapeutic dose (RALT) should be calculated based on each product processed in a specific equipment train and determined by specific formulas and equations A.

Guidance for Swab Sampling and Visual Inspection Locations for API Equipment. (same as VAL MANUAL- 054)

This document guides the selection of the type of routine verification sampling during cleaning validation for particular types of API equipment and recommends locations where to perform swabs and visual inspections conducted during cleaning validation and subsequent routine verification.

Cleaning Validation – Product and Equipment Grouping and Worst-Case Product Selection. (same as VAL MANUAL- 055)

The ability to group products or equipment to reduce the amount of sampling and testing during cleaning validation depends on scientific, documented rationale.

Cleaning Validation – Rinsate and Swab Sample, Test Method Development and Validation. (same as VAL MANUAL- 056)

The area to be swabbed must be defined, and typical areas range from 5cm x 5cm to 4” x 4”. It shall include special requirements and calculations for specific areas or equipment.

Cleaning Validation – Visual Inspection and Quantitation. (same as VAL MANUAL- 057)

Visual inspection only verifies a changeover cleaning process on minor equipment. In that case, the limit of detection using visual inspection techniques should be quantified in the laboratory or referenced from recognized literature.

Cleaning Verification – Investigating Unknown Peaks in Chromatography. (same as VAL MANUAL- 037)

A comparison of an unknown peak to the RAL determines whether an investigation is initiated. Multiple safety factors are typically applied in the RAL calculations.

Cleaning Evaluation Documentation and Instruction – Records for Cleaning Activities. (same as VAL MANUAL- 058)

The cleaning program requires cleaning to be conducted, and the cleaning activities are documented following written instruction records or SOPs with attached checklists.

5.1.3 - Other Validation Guidance

Process Validation Approaches for Formulated Medicinal Products and Medical Devices. (same as VAL MANUAL- 060)

Critical process parameters should be determined by reviewing available historical data generated during development and/or manufacturing or by experimentation.

Identifying Critical Process Parameters for Manufacturing of Medicinal Products. (same as VAL MANUAL- 059)

Understanding the concept and relationship between normal operating range and proven acceptable range is necessary for establishing the range for a critical process parameter.

Equipment Cleaning Validation for Active Pharmaceutical Ingredients. (same as VAL MANUAL- 013)

Equipment cleaning should be conducted, documented, and approved by the site quality and production team. Equipment cleaning evaluation may be a single or several reports, equipment-centric or process-centric, and document or reference the required information.

Equivalence Criteria of Impurities for API Process Validation. (same as VAL MANUAL- 034)

Demonstrating equivalence is needed in all API validations, but this guidance applies to APIs prepared by chemical synthesis.

Equivalency Comparison of Drug Product Validation Batch Data to Reference Batches. (same as VAL MANUAL- 003)

New or modified drug products should be demonstrated to be equivalent to the previously produced product.

Establishing and Extending Clean Equipment Hold Times. (same as VAL MANUAL- 002)

This guidance describes considerations and risks for determining if the establishment of clean equipment hold times for equipment producing drug products and Active Pharmaceutical Ingredients (API) is required.

Evaluating Un-Cleaned Equipment Hold Times for Cleaning Validation of APIs and Drug Products. (same as VAL MANUAL- 004)

This guidance outlines considerations and risks associated with hold times between equipment use and cleaning. It describes recommendations for active pharmaceutical ingredients (APIs) and drug products to evaluate whether the time between equipment use and cleaning needs to be established and controlled.

Evaluation of Changes for Potential Impact on Process Validation. (same as VAL MANUAL- 006)

This guidance provides recommendations and examples for evaluating the process validation impact of changes to manufacturing processes used for manufacturing APIs, Drug Products, and packaging.

General Guidance for Process Validation Sampling. (same as VAL MANUAL- 020 & VAL MANUAL- 022)

This guidance addresses recommendations for good sampling practices. Validation sampling plans must be specified or referenced in the protocol.

Guidance for Swab and Visual Inspection Sampling Locations for Drug Products sample. (same as VAL MANUAL- 007)

This guidance provides recommendations for selecting and applying swab sampling and visual inspection for various types of drug product equipment.

In-Process and Bulk Drug Product Holding Times. (same as VAL MANUAL- 008)

This guidance sets guidelines for determining and validating in-process and bulk product holding times.

Demonstration of Active Pharmaceutical Ingredient (API) Batch Homogeneity. (same as VAL MANUAL- 010)

This guidance demonstrates batch homogeneity of final APIs (small and large molecules) and critical intermediates. This procedure guides performing a homogeneity evaluation supporting API process validation.

Documentation Example for Continuous Quality Verification. (same as VAL MANUAL- 011)

This guidance provides an example of documentation supporting continuous quality verification to demonstrate that a manufacturing process is validated.

Documentation to Support Continuous Quality Verification. (same as VAL MANUAL- 012)

This guidance describes the documentation needed to support continuous quality verification to demonstrate that a drug product or active pharmaceutical ingredient process is in a validated state.

Guidance on Selection Criteria of Dose and Toxicity Data for Use in Cleaning Limit Calculation. (same as VAL MANUAL- 014)

This guidance provides points to consider when selecting dosage and toxicity data for the cleaning limit calculations.

Inspection Attributes in Packaging Validation of Non-Sterile Drug Products. (same as VAL MANUAL- 015)

This procedure provides examples and guidance on categorizing defects for packaged non-sterile drug products.

Laboratory Equipment Qualification. (same as LAB MANUAL – 019)

This procedure guides the qualification of simple, moderate, and complex laboratory equipment used in an analytical laboratory in a Good Manufacturing Practices (GMP) environment associated with products in or intended for the marketplace.

Matrices and Bracketing in Process Validation. (same as VAL MANUAL- 017)

Bracketing and matrixing allow a ‘most appropriate challenge’ condition to be defined for a process or drug product family (the same drug product with different dosage strengths). This risk-based approach can allow the validation to be focused on the most challenging circumstances or “worst cases.”.

Considerations for Selecting Packaging Lot Sizes during Packaging Validation. (same as MFG MANUAL – 001)

This guidance provides examples of primary and secondary packaging validation, as well as both manual and automated operations. It also guides aspects to consider for packaging validation.

Non-Sterile Active Pharmaceutical Ingredient (API) Manufacturing Area Environmental Control. (same as VAL MANUAL – 035)

This guidance addresses environmental control for existing, new, and modified non-sterile API processing areas used to manufacture commercial materials.

Packaging Validation – Potential Critical Process Parameters and Validation Practices. (same as VAL MANUAL- 018)

This guidance provides a tabulation of potential critical process parameters and quality attributes of typical steps of primary solid drug product (i.e., dry products) packaging processes.

Process Validation Sampling for Non-Sterile Liquid, Semi-Solid Drug Products. (same as VAL MANUAL- 020)

This guidance provides process validation sampling guidelines for non-sterile liquid (solutions and suspensions) and semi-solid (ointments, creams, pastes, gels, and lotions) drug product dosage forms.

Process Validation Sampling for Non-Sterile Solid Dose Drug Products. (same as VAL MANUAL- 022)

This guidance provides process validation sampling guidelines for dosage forms for non-sterile solid-dose drug products. Its purpose is to provide the general principles and approaches that should be considered for sampling non-sterile solid dosage forms.

Performance Qualification versus Process Validation. (same as VAL MANUAL- 023)

This guidance compares and contrasts performance qualification (PQ) and process validation (PV) and clarifies how the PQ term is applied to systems and processes.

Periodic Review of Processes and Systems. (same as VAL MANUAL- 025)

This guidance addresses applying a risk-based approach to prioritize the systems and processes for periodic review (PR), justify the frequency and schedule of PR (if applicable), and routinely revalidate processes.

Release For Commercial Use of Drug Products and API Pre-Validation and Validation Batches. (same as QMS MANUAL- 001)

This guidance addresses the commercial release of batches of products manufactured before the process validation (PV) activities and the release of batches associated with performance qualification (PQ) and PV activities.

Semi-Solid Dosage Forms-Critical Process Parameters. (same as VAL MANUAL- 026)

This guidance provides an explanation of the semi-solid drug product dosage form and recommendations for analyzing critical manufacturing process parameters.

Solid Oral Dosage Forms-Potential Critical Process Parameters. (same as VAL MANUAL- 027)

This guidance provides an overview of potential critical process parameters for manufacturing solid oral dosage forms. Solid oral drug products frequently come in various dosage forms with common steps and equipment.

Solvent Recovery Validation Example. (same as VAL MANUAL- 029)

This guidance provides an example of the documentation for validating a solvent recovery process. Solvent recovery validation is needed in some situations, such as where the recovered solvent is intended for general site-wide reuse into suitable manufacturing processes, including API manufacturing processes other than those from which the used solvent originated.

Test Deviations during Validation. (same as VAL MANUAL- 030)

Out-of-specification (OOS) results and any other deviations that may impact the acceptability of the qualification /validation should be documented, investigated, root cause determined, corrective action taken, and reported. Several examples are included.

Validation Activities during Technology Transfers. (same as VAL MANUAL- 031)

This document guides qualification and validation activities resulting from the technology transfer for approved commercial API and drug product processes.

Validation Considerations for Re-work and Re-process of Active Pharmaceutical Ingredients (API). (same as VAL MANUAL- 032)

This document guides us in determining if validation of re-work and re-processing steps are required for active pharmaceutical ingredient (API) processes.

Validation Documentation. (same as VAL MANUAL- 033)

This guidance provides recommendations for the content of the planning, testing, and reporting types of validation documentation.

Shipping Validation for Bio-pharmaceutical Materials Derived from Biotech Processes. (same as VAL MANUAL- 038)

The risk of compromising bio-pharmaceutical materials in shipping is relatively high, as these materials are particularly vulnerable to degradation when exposed to various environmental and handling conditions.

System Level Impact Assessment for Information Systems. (same as VAL MANUAL- 039)

This document explains how the commissioning and qualification system-level impact assessment template can be used for information systems.

Clean Pure Steam System Commissioning and Qualification – Sampling Plans. (same as VAL MANUAL- 041)

This document recommends sampling locations, frequencies, and testing activities associated with the commissioning and qualification of new installations or significant revisions of clean/pure steam systems (e.g., adding new sub-loops or other system-wide retrofitting).

Component Level Impact Assessment for Information System Application. (same as VAL MANUAL- 042)

A component-level impact assessment can be used to classify information system components as critical or non-critical and determine which components need qualification.

Cycle Validation for Freeze Drying. (same as VAL MANUAL- 043)

There are three elements to successfully validating a freeze-drying cycle:

1. A well-defined and understood formulation,

2. A qualified freeze-dryer and a freeze-drying cycle that provides the link between a specific formulation and

3. A specific freeze dryer.

Documenting IQ, OQ, and PQ Protocol Test Results for Equipment, Facility, and Computer. (same as VAL MANUAL- 044)

The following represents the objectives of good test documentation practices. The degree to which these are achieved should be based on the criticality of the function being tested.

Material of Construction (MOC) Documentation. (same as VAL MANUAL- 046)

This procedure provides guidance for allowing vendor’s material of construction (MOC) documentation, such as Certificates of Analysis (C of A) and other record documents, to be accepted as confirmation that a specified material has been used for new systems or components that come into direct contact with the product.

Packaging Process Documentation Transfer for Drug Products. (same as VAL MANUAL- 047)

This document guides document transfer during the activities resulting from the technology transfer for approved commercial packaged Drug Product (DP) processes.

Purified Water and Water for Injection System Commissioning and Qualification Sampling Plans. (same as VAL MANUAL- 048)

This guidance recommends sampling locations, frequencies, and testing activities associated with the commissioning and qualification of purified water (PW) and water for injection (WFI) systems.

Quality Considerations for Direct Impact Compressed Air and Nitrogen Systems. (same as VAL MANUAL- 049)

This guidance provides recommendations when developing specifications for the design of direct impact compressed air, pressure swing adsorption (PSA), and cryogenic nitrogen systems used in the manufacture of active pharmaceutical ingredients (APIs) and drug products (DPs).

240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Additional documents are included each month. All are written and updated by GMP experts. Checkout sample previews. Access to exclusive content for an affordable fee.

5.2 - Quality Management Systems Guidances

Product Quality Complaint Handling. (same as QMS MANUAL- 002)

This complaint-handling guidance defines practices for establishing and maintaining a product quality complaint management system and monitoring and reporting corrective actions based on the findings.

Application of Quality Risk Management to Periodic Review of SOPs. (same as QMS MANUAL- 004)

Application of quality risk management to periodic review of SOPs is intended to provide a tool for determining the optimal review frequency that will ensure those SOPs related to GMP systems or processes are reviewed/revised in a manner.

Statistical Rationale for Raw Material Sampling. (same as QMS MANUAL- 006)

The practice of using the √N+1 as a rule for sample size is expected in the pharmaceutical industry.

Quality Risk Management Application Critical Instrument Calibration. (same as QMS MANUAL- 008)

This document offers a risk assessment approach to document a critical instrument calibration interval change request.

Structured On-the-Job Training System. (same as QMS MANUAL- 012)

This document discusses considerations for site-structured on-the-job training of employees, including GMP tasks and the knowledge necessary to perform those tasks.

Training system for Aseptic Operators and Support Staff. (same as QMS MANUAL- 013)

This document discusses considerations for a robust training system for those working in or in support of preparation for an aseptic processing area.

Disposal of Rejected and Waste Materials. (same as QMS MANUAL- 016)

This document guides the handling, collecting, and disposing of waste materials.

Quality Assurance Self-Appraisals. (same as QMS MANUAL- 019)

This document guides the conducting of quality assurance audits to verify and ensure the effectiveness of ongoing quality systems.

Material Status Indication. (same as QMS MANUAL- 020)

This document guides the control of starting materials and packaging materials, including labeling, in-process materials, drug products, intermediates, medical devices, etc.

Annual Product Records Review. (same as QMS MANUAL- 021)

This document guides the performance of annual product record reviews to evaluate data and trending to verify the consistency of the processes.

Receipt, Approval, and Use of Labels and Labelling. (same as QMS MANUAL- 023)

This document guides the printing, receipt, storage, use, and reconciliation of product labels and labeling for active pharmaceutical ingredients (API), medical devices, and drug products.

Weighing and Measuring Practices in Manufacturing Operations. (same as QMS MANUAL- 025)

This document guides the weighing and measuring of materials used to manufacture drug products.

Material Supplier Approval. (same as QMS MANUAL- 026)

This document provides guidance in the process of identifying suppliers to be audited and the process for conducting and documenting such audits and approving suppliers.

Storage & Distribution of Drug Products, Medical Devices, and Related Materials. (same as QMS MANUAL- 027)

This document guides the storage and distribution requirements for drug products, medical devices, and related production materials from a GMP site.

Control of Manufacturing and Packaging Defects Non-Sterile. (same as QMS MANUAL- 031)

This document guides inspecting non-sterile drug products and non-sterile medical devices for manufacturing and packaging defects.

Pest Control. (same as QMS MANUAL- 032)

This document guides in implementing and maintaining pest control programs for buildings and facilities at a GMP Site.

Raw Materials and Packaging Materials Receipt. (same as QMS MANUAL- 035)

This document guides the receipt and storage of raw materials (RM), components, and packaging materials used in manufacturing and packaging API, drug products, and medical devices.

Sampling of Production Materials and Finished Goods. (same as QMS MANUAL- 036)

This document guides a sampling program for raw materials, packaging, labeling, in-process materials, intermediates, APIs, drug products, biologics, medical devices, etc., with direct or potential product contact.

Water Purification, Storage, and Distribution for Pharmaceutical Production. (same as QMS MANUAL- 039)

This document provides guidance for the purification, storage, and distribution of water used for production, including water used for cleaning product-contact equipment, containers, and closures.

Use of a Risk-Based Approach to Establish External Quality Assurance Audit Frequency. (same as QMS MANUAL- 040)

This document guides GMP quality audit stakeholders using a risk-based approach to determining external Quality Assurance audit prioritization and frequencies.

Reduced Testing Program. (same as QMS MANUAL- 042)

This guidance document defines a science and risk-based approach for evaluating and implementing a reduced testing program for releasing starting materials, intermediates, APIs, excipients, and packaging components at a GMP site.

GMP Training System. (same as QMS MANUAL- 015)

This document discusses considerations for site GMP training systems and the knowledge necessary to perform those tasks.

Stability Testing. (same as QMS MANUAL- 043)

This document guides the stability testing for drug products, consumer non-drug products (e.g., cosmetics), APIs, and medical devices manufactured at GMP facilities.

Quality Risk Management Application to Identify Deviations vs. Events. (same as QMS MANUAL- 051)

This guidance provides a process for assessing if a deviation does or does not impact the product quality or its filing through a quality risk management tool.

Implementation of Real Time Release. (same as QMS MANUAL- 054)

This document provides practical guidance on implementing a real-time release (RTR) testing approach.

Preventative Maintenance. (same as QMS MANUAL- 055)

This document guides preventive maintenance of direct impact systems and associated critical components used in production, storage, and testing that may affect drug products’ safety, identity, strength, quality, or purity.

Calibration. (same as QMS MANUAL- 058)

This document guides calibrating equipment, instruments, and standards used in production.

Evaluation Process Supporting Elimination of Defined Shipment Temperature Range. (same as QMS MANUAL- 059)

This document provides the scientific and risk management assessment process to support the evaluation and, where appropriate, discontinuation of solid oral dosage form shipment under defined temperature range conditions, dependent upon the results of individual product analyses.

Determining Testing Patterns and Acceptance Criteria for Analytical Method Transfers. (same as QMS MANUAL- 063)

This document guides the setting of experimental testing patterns and acceptance criteria for analytical method transfer exercises.

Quality Risk Management to Establishment of Weighing Device Performance Testing Intervals. (same as QMS MANUAL- 066)

The application of quality risk management to performance checks for weighing devices such as balances and scales is intended to provide a tool for determining the acceptability of decreasing the frequency of verifying a weighing device’s performance from the current frequency (e.g., daily) to an alternative schedule.

Analytical Laboratory Management. (same as LAB MANUAL – 002)

This document guides managing analytical laboratories, such as personnel training, proper handling of samples and hazardous materials, control, and maintenance of reagents, reference standards, documentation, and control of test results.

Microbiology Laboratory Management. (same as LAB MANUAL – 004)

This document guides the management of microbiology laboratories.

Transfer of Analytical Methods. (same as LAB MANUAL – 008)

This document guides the establishment of a documented process for transferring analytical, microbiological, and bioanalytical methods.

Quality Agreements. (same as QMS MANUAL- 009)

Quality Agreement is a document between a buyer site and a contractor or supplier of material that defines the roles and responsibilities for quality-related functions of the two parties.

Systems Validation. (same as VAL MANUAL- 050)

This document guides the validation of systems (facilities, utilities, and equipment, including process control and information systems) that support regulatory compliance.

Metal Detection. (same as MFG MANUAL – 004)

This document guides the installation, use, and maintenance of metal detectors in Pharmaceutical and animal health solid oral dosage form drug products and medical devices that, by design, do not contain metal components.

Hose Management. (same as MFG MANUAL – 005)

What minimum standards should an API manufacturing site consider for storing, handling, and cleaning hoses used during the cleaning or production of intermediates or final active pharmaceutical ingredients (APIs)?

Use of Process Analytical Technology in Process Validation. (same as VAL MANUAL- 062)

This document provides examples of the possible use of process analytical technology (PAT) systems during traditional process validation to demonstrate that a manufacturing process is validated.

Implementation of Process Analytical Technology. (same as VAL MANUAL- 051)

The extent of verification testing (incorporating commissioning and qualification), method validation, and approach to deviation investigation will depend on the outcome of the risk assessment. It should be commensurate with the risk associated with the PAT application and the data generated due to application use.

Validation of Process Analytical Technology System. (same as VAL MANUAL- 052)

This document guides the validation of PAT systems to ensure compliance with PAT applications, which can be implemented at a GMP site. The scope of this guidance includes PAT systems used in drug products and active pharmaceutical ingredient (API) manufacturing.

240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Additional documents are included each month. All are written and updated by GMP experts. Checkout sample previews. Access to exclusive content for an affordable fee.

5.3 - Aseptic Processing Area Guidance

Alternatives to Formaldehyde Fogging of Clean Rooms. (same as MFG MANUAL – 006)

Alternatives to formaldehyde fogging include using liquid sanitizers or fogging with an alternate chemical sterilant such as chlorine dioxide, vapor-phase hydrogen peroxide, or atomized peroxyacetic acid-hydrogen peroxide.

Clean Steam Systems. (same as MFG MANUAL – 008)

This document guides clean steam used in aseptic applications and applications where the steam or condensate contacts products or materials or direct product contact surfaces (i.e., equipment, containers, closures) directly.

Cleaning and Sterilization of Aseptic Manufacturing Equipment. (same as MFG MANUAL – 009)

This document provides guidance on cleaning and sterilizing aseptic manufacturing equipment to minimize the risk of particulate and microbiological contamination.

Container Closure Integrity for Sterile Drug Products. (same as MFG MANUAL – 010)

This document ensures that the integrity of the container closure system will protect the product over its shelf life.

Controlling the Microbiological Quality of Solid Oral Dosage Forms. (same as LAB MANUAL – 011)

To control the microbial quality of a non-sterile solid oral dosage form, a risk assessment of the manufacturing process to identify potential sources of microbial contamination is recommended.

Defining Worst Case Conditions for Aseptic Process Simulations. (same as MFG MANUAL – 011)

Aseptic process simulation tests (e.g., media fills) “are used extensively and are recognized as an effective way to validate aseptic filling” processes to comply with regulatory GMP expectations.

Explanation of Repeat Testing and Retesting Utilized During Microbiological OOS Investigations. (same as LAB MANUAL – 015)

This document provides a more detailed explanation of these differences and the individual importance of these tools during a microbiological OOS laboratory investigation.

Gamma Radiation Sterilisation. (same as MFG MANUAL – 012)

This document guides validation of gamma radiation sterilization processes used to sterilize active pharmaceutical ingredients, drug products, medical devices, and non-product items, such as APA gowning articles, containers, and closures with direct or potential contact with sterile raw materials, APIs, drug products or medical devices.

Lyophilization. (same as MFG MANUAL – 013)

This document guides the design, operation, and commissioning or qualification of lyophilizers and the validation of lyophilization processes.

Lyophilizer Loading and Unloading Recommendations. (same as MFG MANUAL – 015)

This guidance should address questions raised by lyophilization (freeze-drying) facilities involved in using automated loading and unloading systems for new lyophilizer installations.

Microbial Attributes Testing of Non-Sterile Solid Oral Dosage Forms and Materials. (same as LAB MANUAL – 028)

This document is meant to help determine the need to perform microbial attributes testing of drug product raw materials, non-sterile excipients, APIs, and finished drug products.

Microbiological Testing in Cleaning Validation for APIs and Drug Products. (same as LAB MANUAL – 021)

This document describes the rationale and recommended microbiological methodology for considering during cleaning validation of product-contact surfaces for Active Pharmaceutical Ingredients and drug products.

This guidance establishes the need for trending environmental monitoring data and gives recommendations on trends such as data categorization, frequency of trending, trend definition, and content of trend reports.

Packaging System Integrity for Sterile Medical Devices. (same as MFG MANUAL – 016)

This document guides the determination of the suitability of packaging materials and the evaluation and testing of the integrity of packaging systems for sterile medical devices manufactured and packaged by GMP sites.

Preventing Cross Contamination. (same as MFG MANUAL – 017)

This document guides preventing cross-contamination in production processes, warehousing, material transfer, and distribution.

Prevention and Control of Fungal Contamination in Tablets. (same as MFG MANUAL – 019)

This document discusses the prevention and control of fungal contamination in tablet production, including raw material and API testing, manufacturing processes, environmental monitoring, and final product testing.

Sanitant Rotation in a Routine Sanitization Program. (same as MFG MANUAL – 020)

What are the expectations for the industry for the inclusion of different sanitization agents within a routine sanitization program?

Sterilization or Depyrogenation Validation – Non-Product. (same as MFG MANUAL – 021)

This procedure guides the validation of sterilization and depyrogenation of equipment, containers, and closures that are in direct or potential contact with sterile medical devices, drug products, or active pharmaceutical ingredients.

Unplanned Clean Room Power Outage & Recovery in Aseptic Processing Areas. (same as MFG MANUAL – 023)

How can the time between a clean room power outage and loss of environmental control in the critical area be determined? Once the power is restored, how can the time it takes to recover the desired environmental conditions be determined?

Use of Sterilized Goggles Within the Aseptic Processing Area. (same as MFG MANUAL – 025)

This document will discuss the requirement for using goggles within aseptic processing areas (APA).

Water Activity – What Is It and How Does It Apply To Pharmaceutical Manufacturing? (same as MFG MANUAL – 027)

This guidance document defines a science- and risk-based approach to evaluating and implementing a reduced testing program for releasing starting materials, intermediates, APIs, excipients, and packaging components at a GMP site.

Assessment of Shipping Processes for Drug Products. (same as MFG MANUAL – 029)

This document guides on assessing the transportation of drug products.

Cold Chain Management of Biopharmaceutical Materials. (same as MFG MANUAL – 030)

The risk of compromising biopharmaceutical materials in internal shipping and external distribution is relatively high, as these materials are particularly vulnerable to degradation when exposed to various environmental and handling conditions.

Stability Considerations for Planned or Unplanned API Process Changes. (same as LAB MANUAL – 025)

This document outlines the considerations site quality organizations should review to assess whether stability data are needed to support planned or unplanned post-approval changes to API or API Intermediate for sale manufacturing processes.

Clean Process – External Vial Capping Operations. (same as MFG MANUAL – 032)

This guidance applies to capping operations performed as an aseptic process using sterilised caps or as a “clean process” performed outside the aseptic core using clean, non-sterilized caps.

Use and Recovery of Solvents in API Manufacturing. (same as MFG MANUAL – 033)

This document guides offloading, using, and recovering solvents used in the commercial manufacture of Active Pharmaceutical Ingredients.

Establishing Re-evaluation Intervals for API Intermediates

This document guides the establishment of re-evaluation intervals for API Intermediates stored dry or wet in drums or intermediate bulk containers (IBC).

Conversion to Animal-free or TSE Risk-Free API Processing

An “animal-free” process does not contain any raw materials, starting materials, components, or agents derived from animals.

Filing Strategy for Specifications for Raw Materials Used in API

This document recommends the strategy for filing specifications for raw materials used in manufacturing Active Pharmaceutical Ingredients (APIs).

Labelling of APIs and API Intermediates

This manual provides guidelines on labeling information for containers for APIs and API Intermediates.

Post Approval Equipment Changes to API Manufacturing Processes

API equipment changes after the final intermediate only require a revision to registrations if the equipment has been explicitly described in a registration commitment or if there is an effect on the drug products.

240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Additional documents are included each month. All are written and updated by GMP experts. Checkout sample previews. Access to exclusive content for an affordable fee.

Pharmaceuticals Quality Assurance and Validation Procedure - GMP SOP contents

We offer clear, authentic, easy-to-follow standard operating procedures for small and medium-sized pharmaceutical companies.

1.0 GMP Standard Operating Procedures (SOP)

1.1 Validation Procedures

1.1.1 Process/Cleaning/Method Validation Procedures

1.1.2 Computer System Validation Procedures

1.1.3 Validation Templates

1.2 Quality Assurance and Compliance Procedures (SOPs)

1.2.3 Quality Assurance Templates

1.3 Quality Control Laboratory Procedures (SOP)

1.4 Microbiology (Sterile) Laboratory Procedures SOP

1.5 Standard Operating Procedure for Packaging Operation

1.6 Warehouse Management Procedures SOP

1.7 Environmental Health and Safety Procedures SOP

2.0 GMP Audit Training Manuals

3.0 Quality and Validation Manuals

3.1 Quality Manuals

3.2 Validation Manuals

3.3 - Laboratory Operations Manuals

3.4 - Manufacturing Operations Manuals

4.0 Good Manufacturing Practice

Practice 4.1: Good Practice on Facilities and Equipment

Practice 4.2 : Good Practice on Material Management

Practice 4.3: Good Practice on Labeling and Packaging

Practice 4.4: Good Practice on Manufacturing Operations

Practice 4.5: Good Practice on Laboratory Management

Practice 4.6: Good Practice on Validation Requirements

Practice 4.7: Good Practice on Quality Management Systems

5.0 GMP Quality and Validation Guidance

5.1 GMP Validation Guidance

5.1.1 - Method Validation

5.1.2 - Cleaning Validation

5.1.3 - Other Validation Guidance

5.2 - Quality Management Systems Guidances

5.3 - Aseptic Processing Area Guidance