Validation by Type of Method - Analytical Validation - page 162

placed on specifications used to evaluate the methods suitability for use. In today's
global market, validation can be a long and costly process, involving regulatory,
governmental, and sanctioning bodies from around the world. A well-defined and
documented validation process provides regulatory agencies with evidence that the
system (instrument, software, method, and controls) is suitable for its intended use.
All parties involved should be confident that a method will give results that are suf-
ficiently accurate, precise, and reproducible for the analysis task at hand, and method
validation is just one of tools to use to accomplish this task.
reFerences
1. The United States Pharmacopeia 34/National Formulary 29 , The United States
Pharmacopeial Convention, Inc., Rockville, MD, 2011, Chapter <1225> Validation of
compendial procedures.
2. Harmonized tripartite guideline, validation of analytical procedures, text and method-
ology, Q2 (R1), International Conference on Harmonization , November 2005, http://
www.ich.org/LOB/media/MEDIA417.pdf.
3. The United States Pharmacopeia 34/National Formulary 29 , The United States
Pharmacopeial Convention, Inc., Rockville, MD, 2011, Chapter <467> Organic volatile
impurities.
4. Draft Guidance for Industry: Analytical Procedures and Methods Validation, U.S.
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.
5. Reviewer Guidance: Validation of Chromatographic Methods, U.S. Department of
Health and Human Services, Food and Drug Administration, Center for Drug Evaluation
and Research, Rockville, MD, November 1994.
6. ICH Q3A(R): Impurities in new drug substances, International Conference on
Harmonization of Technical Requirements for Registration of Pharmaceuticals for
Human Use , Geneva, Switzerland, February 2002.
7. Repič, E., in Principles of Process Research and Development in the Pharmaceutical
Industry , John Wiley & Sons, New York, 1998, pp. 1-54.
8. The United States Pharmacopeia 24/National Formulary 19 , The United States
Pharmacopeial Convention, Inc., Rockville, MD, 1999, Physical Tests, <281> Residue
on ignition, p. 1862.
9. ICH Q7A: Good manufacturing practice guide for active pharmaceutical ingredients,
International Conference on Harmonization of Technical Requirements for Registration
of Pharmaceuticals for Human Use , Geneva, Switzerland, November 2000.
10. The United States Pharmacopeia 34/National Formulary 29 , The United States Pharacopeial
Convention, Inc., Rockville, MD, 2011, General notices, significant figures and tolerances.
11. ICH Q1A(R2): Stability testing of new drug substances and products, International
Conference on Harmonization of Technical Requirements for Registration of
Pharmaceuticals for Human Use , Geneva, Switzerland, February 2003.
12. ICH Q1B: Stability testing: Photostability testing of new drug substances and products,
International Conference on Harmonization of Technical Requirements for Registration
of Pharmaceuticals for Human Use , Geneva, Switzerland, November 1996.
13. Reynolds, D. W., Forced degradation of Pharmaceuticals, Am. Pharm. Review , May/
June, 56-61, 2004.
14. Swartz, M. E., Jones, M. D., and Andrews, M. A., Automated HPLC method develop-
ment and transfer. LCGC Application Notebook , 66-67, June 2002.