Analytical Procedures for NDAs & ANDAs
Brown, R. Faustino, P., Frankewich, R., Gibbs, J., Leutzinger, E., Lunn, G., Ng, L., Rajagopalan, R., Chiu, Y., Sheinin, E., "Analytical Procedures and Method Validation: Highlights of the FDA's Draft Guidance," LC-GC 19, pages 74, 76-79 (2000).

Reproducibility, Reproducibility & Reproducibility
Krull, I.S., "Guest Editorial: Reproducibility, Reproducibility, and Reproducibility," American Laboratory 32, pages 6-8 (2000).

Current Good Manufacturing Practice (CGMP) Regulations
Federal Register 43:45, pages 76-89 (1978).

Code of the Federal Regulations (CFR). 50 volumes. Title 21 Food & Drugs.  Office of the Federal Register, National Archives & Record Administration, United States Government Printing Office, Volume 4 contains part 210 & 211 (1999).