GMP Regulation Handbook: Development & Manufacture of Drug Substances, ICH Q11
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)
Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
The ICH Q11 regulation handbook is used in association with several ISPE training courses:
- Oral Solid Dosage Manufacturing Process Training Course (T10)
- Process Validation in Biotechnology Manufacturing (T32)
- Commissioning and Qualification Training Course (T40)
- Turning QbD into a Practical Reality Training Course (T43)
- Process Validation Training Course (T46)
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