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