Conclusion
The purpose of the use of analytical instruments is to generate reliable data. Instrument qualification helps fulfill this purpose. No authoritative guide exists that considers the risk of instrument failure and combines that risk with users' scientific knowledge and ability to use the instrument to deliver reliable and consistent data. In the absence of such a guide, the qualification of analytical instruments has become a subjective and often fruitless document-generating exercise.
Taking its cue from the new FDA initiative, “Pharmaceutical GMP's for the 21st Century,” an efficient, science- and risk-based process for AIQ was discussed at a workshop on analytical instrument qualification. This report represents the distillate of deliberations on the complicated issues associated with the various stages of analytical instrument qualification. It emphasizes AIQ's place in the overall process of obtaining quality reliable data from analytical instruments and offers an efficient process for its performance, one that focuses on scientific value rather than on producing documents. Implementing such a process should remove ambiguous interpretations by various groups.
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References
- 1.US Food and Drug Administration.Guidance for Industry: Bioanalytical Method Validation. US Dept of Health and Human Services, Food and Drug Administration; May, 2001.
- 2.Shah VP, Midha KM, Findlay JWA, et al. Workshop/Conference Report: Bioanalytical Method Validation: A Revisit with a Decade of Progress. Pharm Res. 2000;17:1551–1557. doi: 10.1023/A:1007669411738. [DOI] [PubMed] [Google Scholar]
- 3.International Conference on Harmonization. ICH Q 2A: Text on Validation of Analytical Procedures.Federal Register. 1995;60 FR 11260. http://www.fda.gov/cder/guidance/ichq2a.pdf.
- 4.International Conference on Harmonization. ICH Q2B: Validation of Analytical Procedures: Methodology.Federal Register. 1997; 62 FR 27463. http://www.fda.gov/cder/guidance/1320fnl.pdf.
- 5.US Department of Health and Human Services.Draft Guidance for Industry: Analytical Procedures and Methods Validation, Chemistry, Manufacturing and Controls Documentation. Rockville, MD: US Dept of Health and Human Services, Food and Drug Administration. Aug 2000. http://www.fda.gov/cder/guidance/2396dft/pdf
- 6.United States Pharmacopoeial Convention.United States Pharmacopoeia 26, National Formulary 21,<1225> Validation of Compendial Methods. Rockville, MD: United States Pharmacopoeial Convention; 2003.
- 7.“Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2002,” Medicines Control Agency-MCA (now Medicines and Healthcare Regulatory Agency-Medicines Section-MHRA), Her Majesty's Stationary Office, London, United Kingdom, 2002.
- 8.National Health and Welfare.Acceptable Methods. Drug Directorate Guidelines, National Health and Welfare, Health Protection Branch, Health and Welfare, Ottawa, Ontario, Canada. 1992.
- 9.US Food and Drug Administration.Guideline on General Principles of Process Validation. Rockville, MD: US Food and Drug Administration, Center for Drug Evaluation and Research. May 1987.
- 10.Furman WB, Layloff TP, Tetzlaff J. Validation of Computerized Liquid Chromatographic Systems. JAOAC. 1994;77:1314–1318. [Google Scholar]
- 11.US Food and Drug Administration.General Principles of Software Validation. Final Guidance for Industry and FDA Staff. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, January, 2002.