GMP Manual Samples
- LAB MANUAL – 001 Environmental Monitoring
- LAB MANUAL – 002 Analytical Laboratory Management
- LAB MANUAL – 003 Water Quality Standard
- LAB MANUAL – 004 Microbiology Laboratory Management
- LAB MANUAL – 005 Sterility Testing
- LAB MANUAL – 006 Endotoxin Testing
- LAB MANUAL – 007 Guideline for Stability Testing for R&D
- LAB MANUAL – 008 Transfer of Analytical Methods
- LAB MANUAL – 009 Storage and Expiry Dating of Analytical Reagents
- LAB MANUAL – 010 Preparation & Maintenance of Stability Protocols and Stability Master Plans
- LAB MANUAL – 011 Controlling the Microbiological Quality of Solid Oral Dosage Forms
- LAB MANUAL – 012 Commercial Stability Testing of API (Pure Bulk Drug)
- LAB MANUAL – 013 Commercial Stability Studies at Contractors
- LAB MANUAL – 014 R&D GLP QA Record Retention Procedure
- LAB MANUAL – 015 Explanation of Repeat Testing and Retesting Utilized During
- LAB MANUAL – 016 Microbiological Testing for Non Sterile Drug Product
- LAB MANUAL – 017 Reference & Retention Samples
- LAB MANUAL – 018 Laboratory Equipment Qualification – PART 1
- LAB MANUAL – 019 Laboratory Equipment Qualification – PART 2
- LAB MANUAL – 020 Manufacture and Microbiological Testing of Sterile API & Drug Product Within R&D
- LAB MANUAL – 021 Microbiological Testing in Cleaning Validation for APIs and Drug Products
- LAB MANUAL – 022 Commercial Stability Testing For Formulated Products
- LAB MANUAL – 023 Overview of Trending of Environmental Monitoring
- LAB MANUAL – 024 Trending of Stability Data
- LAB MANUAL – 025 Stability Considerations for Planned or Unplanned API Process Changes
- LAB MANUAL – 026 Out of Specification Results Investigation
- LAB MANUAL – 027 Analytical Procedures and Validation
- LAB MANUAL – 028 Microbial Attributes of Non Sterile Solid Materials Testing
- MFG MANUAL – 001 Considerations for Selecting Packaging Lot Sizes During Packaging
- MFG MANUAL – 002 Management of Non-Sterile Active Pharmaceutical Ingredient Manufacturing Area
- MFG MANUAL – 003 Manufacturing Documentation
- MFG MANUAL – 004 Installation, Use and Maintenance of Metal Detectors in Pharmaceutical
- MFG MANUAL – 005 Storage, Handling and Cleaning of Hoses Used in Pharmaceutical Production
- MFG MANUAL – 006 Alternatives to Formaldehyde Fogging of Clean Rooms
- MFG MANUAL – 007 Maintenance and Calibration of GMP Critical Item
- MFG MANUAL – 008 Clean Steam Systems
- MFG MANUAL – 009 Cleaning and Sterilization of Aseptic Manufacturing Equipment
- MFG MANUAL – 010 Container Closure Integrity for Sterile Drug Products
- MFG MANUAL – 011 Defining Worst Case Conditions for Aseptic Process Simulations
- MFG MANUAL – 012 Gamma Radiation Sterilization
- MFG MANUAL – 013 Validation of Lyophilization Processes
- MFG MANUAL – 014 Retreatment and Blending of API & Formulated Product
- MFG MANUAL – 015 Lyophilizer Loading and Unloading Recommendations
- MFG MANUAL – 016 Packaging System Integrity for Sterile Medical Devices
- MFG MANUAL – 017 Preventing Cross Contamination
- MFG MANUAL – 018 In-Process Testing, Checks and Sampling
- MFG MANUAL – 019 Prevention and Control of Fungal Contamination in Tablets
- MFG MANUAL – 020 Sanitant Rotation in a Routine Sanitization Program
- MFG MANUAL – 021 Sterilization or Depyrogenation Validation for Non Product Components
- MFG MANUAL – 022 Returned Goods
- MFG MANUAL – 023 Unplanned Cleanroom Power Outage Time Limit and Recovery
- MFG MANUAL – 024 Receipt Handling and Storage of Starting & Packaging Materials
- MFG MANUAL – 025 Use of Sterilized Goggles Within the Aseptic Processing Area
- MFG MANUAL – 026 Control of Packaging Operation
- MFG MANUAL – 027 Water Activity Fundamentals and Applications in Pharmaceutical Operations
- MFG MANUAL – 028 Requirements for Facilities for Sterile and Non-sterile Drug Manufacture
- MFG MANUAL – 029 Assessment of Shipping Processes for Drug Products
- MFG MANUAL – 030 Cold Chain Management of Biopharmaceutical Materials
- MFG MANUAL – 031 Labeling and Packaging of Investigational Medicinal Products and APIs in R&D
- MFG MANUAL – 032 Sterile & Non Sterile Vial Capping Operations
- MFG MANUAL – 033 Use and Recovery of Solvents in API Manufacturing
- MFG MANUAL – 034 Principles and Responsibilities for The Management of Change in Operations
- QMS MANUAL- 001 Release for Commercial Use of Drug Product Pre-Validation & Validation Batches
- QMS MANUAL- 002 Product Quality Complaint Handling
- QMS MANUAL- 003 Evaluation of Contaminant Options for Packing of Solid Dosage Forms
- QMS MANUAL- 004 Application of Quality Risk Management to Periodic Review of SOPs
- QMS MANUAL- 005 Retention and Disposal of GMP Documents and Retention Samples
- QMS MANUAL- 006 Statistical Rationale for Raw Material Sampling
- QMS MANUAL- 007 Certificate of Materials Supplied to Receiving Site
- QMS MANUAL- 008 Quality Risk Management Application Critical Instrument Calibration
- QMS MANUAL- 009 Quality Agreements – PART 1
- QMS MANUAL- 010 Quality Agreements – PART 2
- QMS MANUAL- 011 Procedure for Quality Management of Contractors
- QMS MANUAL- 012 Structured On-the-Job Training System
- QMS MANUAL- 013 Training system for Aseptic and Preparation for Aseptic Operators and Support Staff
- QMS MANUAL- 014 Auditor Training
- QMS MANUAL- 015 GMP Training System
- QMS MANUAL- 016 Disposal of Rejected and Waste Materials
- QMS MANUAL- 017 Guidelines for Regulatory Inspections
- QMS MANUAL- 018 Quality and Compliance Auditing
- QMS MANUAL- 019 Quality Assurance Self-Appraisals
- QMS MANUAL- 020 Material Status Indication
- QMS MANUAL- 021 Annual Product Records Review – PART 1
- QMS MANUAL- 022 Annual Product Reviews – PART 2
- QMS MANUAL- 023 Receipt, Approval and Use of Labels and Labeling
- QMS MANUAL- 024 Warehousing and Distribution of Commercial Products
- QMS MANUAL- 025 Weighing and Measuring Practices In Manufacturing Operations
- QMS MANUAL- 026 Material Supplier Approval
- QMS MANUAL- 027 Storage & Distribution of Drug Products and Medical Devices
- QMS MANUAL- 028 Facility Based R&D QA Audit
- QMS MANUAL- 029 Compliance Improvement Plan
- QMS MANUAL- 030 Archiving, Disposal and Record Management
- QMS MANUAL- 031 Control of Manufacturing and Packaging Defects Non Sterile
- QMS MANUAL- 032 Pest Control
- QMS MANUAL- 033 Utility Standards
- QMS MANUAL- 034 Conducting Investigations in a GMP Site
- QMS MANUAL- 035 Raw Materials and Packaging Materials Receipt
- QMS MANUAL- 036 Sampling of Production Materials and Finished Goods
- QMS MANUAL- 037 Management and Documentation of Training
- QMS MANUAL- 038 Definition and Documentation of Raw Data
- QMS MANUAL- 039 Water Purification, Storage and Distribution for Pharmaceutical Production
- QMS MANUAL- 040 Use of a Risk-Based Approach to Establish External QA Audit Frequency
- QMS MANUAL- 041 Risk Management in the Quality and Compliance Area
- QMS MANUAL- 042 Reduced Testing Program
- QMS MANUAL- 043 Stability Testing
- QMS MANUAL- 044 Internal Quality Assurance Agreements
- QMS MANUAL- 045 Audit of a Distribution Site
- QMS MANUAL- 046 Supplier Auditing for GMP Facility
- QMS MANUAL- 047 Management of Master GMP Document
- QMS MANUAL- 048 Artwork Creation & Control of Printed Packaging Components
- QMS MANUAL- 049 Release of API Bulk Formulated Products & Part Finished Packs
- QMS MANUAL- 050 Computerized Systems Risk Management
- QMS MANUAL- 051 Quality Risk Management Application to Identify Deviations vs. Events
- QMS MANUAL- 052 Deviation Management
- QMS MANUAL- 053 Study Based GLP QA Audit for Critical Phases
- QMS MANUAL- 054 Implementation of Real Time Release
- QMS MANUAL- 055 Preventive Maintenance
- QMS MANUAL- 056 Batch Confirmation Certification & Release by a Qualified Person within the EU
- QMS MANUAL- 057 Cross Contamination Risk Evaluation Process for Commercial Compounds
- QMS MANUAL- 058 Calibration
- QMS MANUAL- 059 Evaluation Process Supporting Elimination of Defined Shipment Temperature Range
- QMS MANUAL- 060 Guideline for Development and Contents of Specifications
- QMS MANUAL- 061 R&D QA Audits for Suppliers and Vendors
- QMS MANUAL- 062 Certificate of Analysis & Certificate of Manufacture
- QMS MANUAL- 063 Determining Testing Patterns and Acceptance Criteria for Analytical Method Transfers
- QMS MANUAL- 064 Manufacture Packing and Shipping of Materials Ahead of Full QA Clearance
- QMS MANUAL- 065 Determination of Storage Periods for API Excipients Intermediates and Raw Materials
- QMS MANUAL- 066 Risk Management Application to Establishment of Weighing Device Performance Testing Intervals
- QMS MANUAL- 067 Electronic Records and Electronic Signatures
- VAL MANUAL- 001 The Preparation of Validation Master Plan
- VAL MANUAL- 002 Clean Equipment Hold Times Establishment and Practices
- VAL MANUAL- 003 Equivalency Comparison Techniques of Medicinal Validation Batches
- VAL MANUAL- 004 Evaluating Non-Cleaned Equipment Hold Times for Cleaning Validation
- VAL MANUAL- 005 Process Validation of Bulk Drug (API and Intermediate)
- VAL MANUAL- 006 Evaluation of Changes for Potential Impact on Process Validation
- VAL MANUAL- 007 Swab and Visual Inspection Sampling Locations Guidance for Drug Product Equipment
- VAL MANUAL- 008 In-Process and Bulk Drug Product Holding Times
- VAL MANUAL- 009 Process Validation for Formulated Products
- VAL MANUAL- 010 Batch Homogeneity Demonstration of Active Pharmaceutical Ingredient Preparation
- VAL MANUAL- 011 Documentation Models for Continuous Quality Verification
- VAL MANUAL- 012 Documentation to Foster Continuous Quality Verification
- VAL MANUAL- 013 Cleaning and Cleaning Validation of API Plant and Equipment
- VAL MANUAL- 014 Guidance on Selection Criteria of Dose and Toxicity Data
- VAL MANUAL- 015 Inspection Attributes in Packaging Validation of Non-Sterile Drug Products
- VAL MANUAL- 016 Sterilization Process Validation
- VAL MANUAL- 017 Matrices and Bracketing of Medicinal Products in Process Validation
- VAL MANUAL- 018 Potential Critical Packaging Process Parameters and Validation Practices
- VAL MANUAL- 019 Cleaning and Cleaning Validation For Formulated Products
- VAL MANUAL- 020 Process Validation Sampling Practices for Non-Sterile Liquid and Semi Solid Drug Products
- VAL MANUAL- 021 Principle and Procedures of Analytical Test Method Validation for GMP Regulated Industry
- VAL MANUAL- 022 Process Validation Sampling for Non-Sterile Solid Dose Drug Products
- VAL MANUAL- 023 Performance Qualification versus Process Validation
- VAL MANUAL- 024 General Outline of Analytical Procedure Validation
- VAL MANUAL- 025 Periodic Review Process of Validated Equipment & Computer Systems
- VAL MANUAL- 026 Critical Parameters for Process Involves in Formulating Semi-Solid Dosage Forms
- VAL MANUAL- 027 Potential Critical Parameters for Process involves in Formulating Solid Oral Dosage Forms
- VAL MANUAL- 028 The validation of facilities and system
- VAL MANUAL- 029 Examples and Approaches of Solvent Recovery Validation
- VAL MANUAL- 030 Identification and Investigation of Test Deviations During Validation
- VAL MANUAL- 031 Validation Activities during Technology Transfers
- VAL MANUAL- 032 Validation Considerations for Re-work and Re-process of API
- VAL MANUAL- 033 Validation Documentation
- VAL MANUAL- 034 Demonstration and Calculation of Equivalence Criteria of Impurities for API Process Validation
- VAL MANUAL- 035 Measurement of Critical Parameters and Process Steps for Manufacturing Medicinal Products
- VAL MANUAL- 036 Information Technology Infrastructure Qualification
- VAL MANUAL- 037 How to Investigate Unknown Chromatographic Peaks during Cleaning Validation Activity
- VAL MANUAL- 038 Validation Considerations for Transportation of Biopharmaceutical Materials
- VAL MANUAL- 039 System Level Impact Assessment for Information Systems
- VAL MANUAL- 040 Management of Change in Computerized System
- VAL MANUAL- 041 Clean Pure Steam System Commissioning and Qualification Approaches & Sampling Plans
- VAL MANUAL- 042 Component Level Impact Assessment for Information System Application
- VAL MANUAL- 043 Cycle Validation for Freeze Drying
- VAL MANUAL- 044 Documenting IQ, OQ, PQ Protocol Test Results for Equipment, Facility and Computer
- VAL MANUAL- 045 Access by Regulatory Authorities and Auditors to Electronic Records
- VAL MANUAL- 046 Material of Construction Documentation
- VAL MANUAL- 047 Packaging Process Documentation Transfer for Drug Products
- VAL MANUAL- 048 Purified Water & Water for Injection System Commissioning and Qualification Sampling Plans
- VAL MANUAL- 049 Quality Considerations for Direct Impact Compressed Air and Nitrogen Systems
- VAL MANUAL- 050 Systems Validation
- VAL MANUAL- 051 Implementation of Process Analytical Technology
- VAL MANUAL- 052 Validation of Process Analytical Technology System
- VAL MANUAL- 053 Calculations of Residue Limits for Medicinal Product for Equipment Cleaning Validation
- VAL MANUAL- 054 Identification & Sampling Procedure of Swab & Visual Inspection Locations for Equipment
- VAL MANUAL- 055 How to Group Product and Equipment and Select the Worst Case Product in Cleaning Validation
- VAL MANUAL- 056 Rinsate and Swab Sampling Procedure in Test Method Development and Validation
- VAL MANUAL- 057 Method of Visual Inspection and Quantitation in Cleaning Validation
- VAL MANUAL- 058 Documentation and Records for Cleaning Activities and Evaluation
- VAL MANUAL- 059 Identifying Critical Process Parameters for Manufacturing of Medicinal Products
- VAL MANUAL- 060 Process Validation Approaches for Formulated Medicinal Products and Medical Devices
- VAL MANUAL- 061 Cleaning Validation and Verification of Equipment Used for Manufacturing Active Pharmaceutical Ingredients
- VAL MANUAL- 062 Use of Process Analytical Technology in Process Validation