System Suitability Test
McDowall, R.C., "Why system suitability tests are not a substitute for analytical instrument qualification or calibration, Part I,", LC-GC 28 pages 1038-1041 (2010).

The Application Notebook
"Biological, Drugs of Abuse, Environmental, Food & Beverages, Pharmaceutical, General," see "The Application Notebook", Supplement to LC GC (August 2002).

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Ng, L., Rajagopalan, R., Chiu, Y., Sheinin, E., "Analytical Procedures and Method Validation: Highlights of the FDA's Draft Guidance," LC-GC 19, pages 74, pages 76-79 (2000).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).

Code of the Federal Regulations
(at FDA, Choose CFR Title 21)

"Guidance Documents"
(from the FDA)

CGMP Notes
(at the FDA)

International Conference on Harmonization (ICH)
(at FDA, Choose ICH)