NOTICE:
Please be aware that ISPE Headquarters in Tampa, Florida USA is under a hurricane watch through Thursday 29 September. We appreciate your patience during this time as we work to assist you. Please note there could be delays in response time. We will continue to do our best to provide efficient service.
GMP Regulation Handbook: General, Finished Pharmaceuticals, 21 CFR Parts 210 & 211
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)
Note: ISPE is transitioning to a new shipping service provider. Bound copies of Guides will not be shipped until after 1 October. Digital versions are available for download once purchased.