Validation of pharmaceutical test methods

Separation Science and Technology

Volumn 3, Issue C, 2001, Pages 415-443

  Crowther, Jonathan B ^a  

^a Ortho Clinical Diagnostics   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 79959561676     PISSN: 18771718     EISSN: None     Source Type: Book Series    
DOI: 10.1016/S0149-6395(01)80014-3     Document Type: Book

References (27)

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2. Federal Register 21 CFR 211.165(e) and 211.194 (a)(2).
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4. Miller, J. M. and Crowther, J. B. Analytical Chemistry in a GMP Environment. Wiley, New York, 2000.
5. Johnson, J. D. and Van Buskirk, G. E. Analytical method validation. J. Validation Technol. 2:88-105, 1998.
6. International Conference on Harmonization. Guideline on validation of analytical procedures: Methodology. Federal Register 61:59-62, 1996.
7. Reviewers guidance, validation of chromatographic methods. Center for Drug Evaluation and Research, Food and Drug Administration, 1994.
8. International Conference on Harmonization. Guideline on validation of analytical procedures: Definitions and terminology; availability. Federal Register 60:11260-11262, 1995.
9. Jenke, D. R. Chromatographic method validation II. Guidelines for primary validation parameters. J. Liq. Chromatogr. Related Technol. 19:737-757, 1996.
10. Validation of compendial methods. United States Pharmacopeia, USP 23, 1225.
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12. PMA Computer Systems Validation Committee. Computer systems validation-Staying current: Introduction. Pharm. Technol. 13:60-65, 1980.
13. Jimidar, M., Niemeijer, N., Peeters, R., and Hoogmartens, J. Robustness testing of a liquid chromatography method for the determination of Vorozole and its related compounds in oral tablets. J. Pharm. Biomed. Anal. 18:479-485, 1998.
14. Analytical procedures and method validation: Chemistry, manufacturing, and controls documentation. Draft Guidance, August 2000. http://wwM7.fda.gov/cber/guideUnes.htm.
15. Jimidar, M., Hartmann, C., Cousement, N., and Massart, D. L. J. Chromatogr., A 706:479, 1995.
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17. Wahlich, J. C. and Carr, G. P. Chromatographic system suitability tests: What should we be using? J. Pharm. Biomed. Anal. 8:619-623, 1990.
18. DeSain, C. Master method validation protocols. BioPharm 6:30-34, 1992.
19. Johnson, J. D. and Van Buskirk, G. E. Analytical method validation. J. Validation Technol. 2:88-105, 1998.
20. Guideline for submitting samples and analytical data for methods validation. U.S. Food and Drug Administration, 1987.
21. Massart, D. L., Vandeginste, B. G. M., Deming, S. N., Michotte, Y., and Kaufman, L. Chemometrics: A Textbook. Data Handling in Science and Technology Vol. 2. Elsevier, Amsterdam, 1988.
22. Green, J. M. A practical guide to analytical method vaUdation. Anal. Chem. 68:305A-309A, 1996.
23. Jenke, D. R. Chromatographic method validation: A review of current practices and procedures II. Guidelines for primary validation parameters. J. Liq. Chromatogr. Related Technol 19:737-757, 1996.
24. Hokanson, G. C. A life cycle approach to the validation of analytical methods during pharmaceutical product Development II. Changes and the need for additional validation. Pharm. Technol. 18:92-100, 1994.
25. PMA Workshop on Reference Standards. PMA Analytical Steering Committee, Washington, DC, 1992.
26. Housepian, P. K. Bulk drug substances and finished products. In Development and Validation of Analytical Methods (C. M. Riley and T. W. Rpsanke, Eds.). Pergamon, Oxford, UK, 1996.
27. FDA guidelines for supporting documentation in drug applications for the manufacturing of drug substances, 1987.