Introduction to Analytical Method Validation - Analytical Validation - page 21

11. Draft Guidance for Industry: Analytical Procedures and Methods Validation. US
Department of Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, Center for Biologics Division of Research, Rockville,
MD, August 2000.
12. Current Good Manufacturing Practice for Finished Pharmaceuticals, 21 CFR Part
211, http://www.fda.gov/cder/dmpq/cgmpregs.htm.
13. The United States Pharmacopeia 34/National Formulary 29 , The United States
Pharmacopeial Convention, Inc., Rockville, MD, 2011, Chapter <1225>.
14. Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or
Holding of Drugs, 21 CFR Part 210, http://www.fda.gov/cder/dmpq/cgmpregs.htm.
15. FDA, General Principles of Software Validation; Guidance for Industry and FDA Staff.
See http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm085371.pdf.
16. FDA Guidance for Industry, Computerized Systems Used in Clinical Investigations,
May 2007. See http://www.fda.gov/cder/guidance/7359fnl.htm.
17. FDA, 21 CFR Part 11, Electronic Records; Electronic Signatures; Final Rule . Fed. Reg.,
Vol. 62, No. 54, p. 13429, March 20, 1997.
18. FDA, CFR Part 11, Electronic Records; Electronic Signatures—Scope and Application,
2003. See http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory
Information/Guidances/ucm072322.pdf.
19. Qualification of analytical instruments for use in the pharmaceutical industry: A scientific
approach , AAPS PharmSciTech , 2004, 5(1) Article 22 (http://www.aapspharmscitech.org).
20. Hertzog, D. L., et al., Developed and validated stability-indicating HPLC method for
the simultaneous determination of losartan potassium, hydrochlorothiazide, and their
degradation products, Pharm. Forum , 31(5), Sept-Oct 2005, pp. 1453-1463.
21. The United States Pharmacopeia 34/National Formulary 29 , The United States
Pharmacopeial Convention, Inc., Rockville, MD, 2011, Chapter <1058>.
22. Swartz, M. E., Analytical Instrument Qualification, Pharmaceutical Regulatory
Guidance Book ,Advanstar(publisher),SupplementtoLC•6CMagazineSantaMonica
CA, pp. 12-16, July 2006.
23. The United States Pharmacopeia 34/National Formulary 29 , The United States
Pharmacopeial Convention, Inc., Rockville, MD, 2011, Chapter <621>.
24. www.fda.gov/foi/warning.htm and search for “Training” for more examples.