GMP Regulation Handbook: General, Finished Pharmaceuticals, 21 CFR Parts 210 & 211
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Regulation Handbook: 21 CFR Parts 210 (General) & 211 (Finished Pharmaceuticals)
Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General and Current Good Manufacturing Practice for Finished Pharmaceuticals
The Pharmaceuticalhandbook is used in association with several ISPE training courses:
- GMP Auditing for Quality Assurance Training Course (G07)
- Applying the GMPs (G03)
- Pharma Water Generation USP WFI & Purified Water Training Course (T04)
- GAMP® Basic Principles Training Course (T07)
- GAMP® Part 11 Training Course (T08)
- Practical Application of Computerized Systems Compliance: Applying the GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems (T11)
- GMP Sterile Pharmaceutical Manufacturing Facility Training Course (T12)
- Clinical Trial Materials Training Course (T13)
- Storage, Delivery and Qualification Pharma Water Training Course (T23)
- Biotechnology Manufacturing Facility Design Training Course (T31)
- GAMP 5®, Annex 11/Part 11 Basic Principles Training Course (T45)