It’s not easy to cross-reference FDA regs and guidance on the FDA website: CGMP Concise Desk Reference Needed

Originally posted November 9, 2009

​The FDA website is designed to allow the user to search on terms only within the sections the user specifies. This means we frequently miss, or are not aware of, all of the regulations and guidance documents that apply to us in industry. The pocket CFR manuals available at conferences and training events are not easy to search and don’t include all of the information we need. This book fills in the gaps.
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“Current Good Manufacturing Practices: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference” (634 pages)
Included Reference Tools:

• CGMP Overview (perfect for cGMP annual training)
• Glossaries combined and cross-referenced in one location
• GMP Keyword Index for 21CFR211
• Combined Index for all regulations and guidance documents
• Chapters 1 and 2 provide all of the orientation information for mandatory annual cGMP refresher training.

FDA Regulations and Associated Guidance Documents:

• Part 11 Electronic Records; Electronic Signatures
• Part 26 Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and the European Community
• Part 200 Drugs General
• Part 207 Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
• Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs
• Part 211 Current Good Manufacturing Practice For Finished Pharmaceuticals
• Part 600 Biological Products: General
• Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
• Part 820 Quality System Regulation
• FDA Regulation and Guidance Overview
•  Guidance for Industry: Part 11
• Current Good Manufacturing Process for Combination Products
• CGMP for Phase 1 Investigational Drugs
• PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
• Quality Systems Approach to Current Good Manufacturing Practice Regulations
• Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
• Questions and Anaswers on Current Good Manufacturing Practices (cGMP) for Drugs
• Guideline on General Principles of Process Validation
• Guidance for Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP