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: