1. Federal Food. Drug, and Cosmetic Act (Public Law No. 75–717 52 Stat. 1040) 1938.
2. International Conference on Harmonization. Guidance for Industry—Q7A: Good Manufacturing Practice (GMP) Guidance for Active Pharmaceutical ingredients. Geneva, Switzerland: international Conference on Harmonization; August 2001.
3. US Food and Drug Administration. Current Good Manufacturing Practice for the Manufacture, Processing, Packaging and Holding of Drugs, 21 CFR — Parts 210 and 211, Rockville, MD: US Food and Drug Administration; March 1998.
4. US Food and Drug Administration. Drug Manufacturing Inspections—Compliance Program Guidance Manual. Rockville, MD: US Food and Drug Administration; October 2000.
5. DeCamp WH. The impact of polymorphism on drug development—A regulator’s point of view. Am Pharm Rev. 2001;4(3):70–77.