1. ICH
Q7Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients; U.S. Department of Health and HumanServices, Food
and Drug Administration, Center for Drug Evaluationand Research (CDER): Rockville, MD, 2000.
2. Guideline
for Submitting Supporting Documentation in Drug Applications for the
Manufacture of Drug Substances; U.S. Department
of Health and Human Services, Food and Drug Administration, Center
for Drug Evaluation and Research (CDER): Rockville, MD, 1987.
3. FDA
Draft Guideline, Guidance for Industry: Drug Substance: Chemistry,
Manufacturing and Controls Information; U.S.
Department of Health and Human Services, Food and Drug Administration,
Center for Drug Evaluation and Research (CDER): Rockville, MD, 2004. Withdrawn Federal
Register, Notice: June 1, 2006.
4. ICH
Q11 Development and Manufacture of Drug Substances (Chemical Entities
and Biotechnological/Biological Entities); U.S. Department of Health and HumanServices, Food and Drug Administration,
Center for Drug Evaluationand Research (CDER): Rockville, MD, 2012.
5. Part 1: A Review and Perspective of the Regulatory Guidance to Support Designation and Justification of API Starting Material