GMP Regulation Handbook: Pharmaceutical Quality System, ICH Q10
Guidance for Industry Q10 Pharmaceutical Quality System. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER)
The ICH Q10 regulation handbook is used in association with several ISPE training courses:
- Commissioning and Qualification Training Course (T40)
- Quality Risk Management Workshop (T42)
- Turning QbD into a Practical Reality Training Course (T43)
- Process Validation Training Course (T46)
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