GMP Manufacturing & Quality Assurance Manuals
Manual - 001 Evaluation of Contaminant Options for Packing of Solid Dosage Forms
Manual - 002 Retention and Disposal of GMP Documents and Retention Samples
Manual - 003 Certificate of Materials Supplied to Receiving Manufacturing Site
Manual - 004 Quality Assurance Agreements
Manual - 005 Procedure for Quality Assurance Management of Contractors
Manual - 006 Guidelines for Regulatory Inspections
Manual - 007 Quality and Compliance Auditing
Manual - 008 Facility Based R&D Quality Assurance Audit
Manual - 009 Auditor Training
Manual - 010 GMP Compliance Improvements Plans
Manual - 011 Archiving, Disposal and Record Management
Manual - 012 Internal Quality Assurance Agreements
Manual - 013 Audit of a Distribution Site
Manual - 014 Supplier Auditing
Manual - 015 Management of Master GMP Document
Manual - 016 Artwork Creation & Control of Printed Packaging Components
Manual - 017 Release of API Bulk Formulated Products & Part Finished Packs
Manual - 018 Computerized Systems Risk Management
Manual - 019 Batch Confirmation Certification & Release by a Qualified Person within the EU
Manual - 020 Cross Contamination Risk Evaluation Process for Commercial Compounds
Manual - 021 Certificate of Analysis & Certificate of Manufacture
Manual - 022 Pharmaceutical Product Reviews
Manual - 023 Warehousing and Distribution of Commercial Products
Manual - 024 Utility Standards
Manual - 025 Conducting Investigations
Manual - 026 Management and Documentation of Training
Manual - 027 Definition and Documentation of Raw Data
Manual - 028 Risk Management in the Quality Assurance and Compliance Area
Manual - 029 Manufacturing Deviation Management
Manual - 030 Study Based GLP Quality Assurance Audit for Critical Phases
Manual - 031 Guideline for Development and Contents of Specifications
Manual - 032 R&D QA Audits for Suppliers and Vendors
Manual - 033 Manufacture Packing and Shipping of Materials Ahead of Full QA Clearance
Manual - 034 Determination of Storage Periods for APIs Excipients Intermediates and Raw Materials
Manual - 035 The Preparation of Process Validation Master Plan
Manual - 036 Process Validation of Bulk Drug (API and Intermediate)
Manual - 037 Process Validation for Formulated Products
Manual - 038 Cleaning and Cleaning Validation of API Plant and Equipment
Manual - 039 Sterilization Process Validation
Manual - 040 Cleaning and Cleaning Validation For Formulated Products
Manual - 041 Analytical Laboratory Procedure Validation
Manual - 042 Water Quality Standard
Manual - 043 Sterility Testing Procedure
Manual - 044 Endotoxin Testing Procedure
Manual - 045 Guideline for Stability Testing for R&D
Manual - 046 Storage and Expiry Dating of Analytical Reagents in Laboratory
Manual - 047 Preparation & Maintenance of Stability Protocols and Stability Master Plans
Manual - 048 Commercial Stability Testing of API (Pure Bulk Drug)
Manual - 049 Commercial Stability Studies at Contractors
Manual - 050 R&D Laboratory Quality Assurance Record Retention Procedure
Manual - 051 Microbiological Testing for Non Sterile Drug Product
Manual - 052 Reference & Retention Samples
Manual - 053 Laboratory Equipment Qualification
Manual - 054 Manufacture and Microbiological Testing of Sterile API & Drug Product Within R&D
Manual - 055 Commercial Stability Testing For Formulated Products
Manual - 056 Environmental Monitoring
Manual - 057 Trending of Stability Data
Manual - 058 Laboratory Out of Specification Results Investigation
Manual - 059 Manufacturing Documentation
Manual - 060 Maintenance and Calibration of GMP Critical Items in Manufacturing Operations and R&D
Manual - 061 Retreatment and Blending of API & Formulated Product
Manual - 062 In-Process Testing, Checks and Sampling
Manual - 063 Management of Returned Goods
Manual - 064 Receipt Handling and Storage of Starting & Packaging Materials
Manual - 065 Control of Packaging Operation
Manual - 066 Requirements of Facilities For Sterile and Non-sterile Drug Manufacturing
Manual - 067 Labeling and Packaging of Investigational Medicinal Products and APIs in R&D
Manual - 068 Principles and Responsibilities for The Management of Change in Manufacturing Operations
Manual - 069 The Validation of Facilities and Systems
Manual - 070 Information Technology Infrastructure Qualification
Manual - 071 Management of Change in Computerised System
Manual - 072 Access by Regulatory Authorities and Auditors to Electronic Records
Manual - 073 Guidelines for Generating Manufacturing Documentations
Manual - 074 Electronic Records and Electronic Signatures
Manual - 075 Retreatment and Blending of API and Formulated Products
Manual - 077 Analytical Procedures and Validation
Manual - 078 Technology Transfer of Established Medicine from One Commercial Site to Other
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