GMP Regulation Handbook: Pharmaceutical Development, ICH Q8(R2)

Guidance for Industry, Pharmaceutical Development Q8(R2)

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 Q8R2 regulation handbook is used in association with several ISPE training courses: