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 - 078 Technology Transfer of Established Medicine from One Commercial Site to Other.......................................
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GMP Manuals
