Abstract
Analytical validation is required as the basis for any evaluation activities during manufacturing process validation, cleaning validation and validation of the testing method itself in the pharmaceutical industry according to good manufacturing practice (GMP) rules and guidelines. Validation of analytical methods and procedures in a quality control (QC) laboratory is implemented mainly at the time of transfer or introduction of the methods developed by the analytical development laboratory within group companies or elsewhere. However, it is sometimes necessary to develop a new or improved method of analysis for the QC laboratory’s own use. In the first part of this report, a general description of analytical validation of the high performance liquid chromatography (HPLC) method including preparation of documents is presented based on the experience in our QC laboratory. A typical example of method validation of robotic analysis system is then cited. Finally the merits and demerits of these analytical validations for QC laboratories are summarized. The authors emphasize the importance of analytical validation and the responsibility of QC laboratory management for the effective design and implementation of validation activities.
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References
Regulations for Manufacturing Control and Quality Control of Drugs (GMP of Japan), amended in January 1994, Ministry of Health and Welfare, Japan
CFR Title 21 Part 211-Current Good Manufacturing Practice for Finished Pharmaceuticals, revised in January 1995, Food and Drug Administration, Department of Health and Human Services, USA
Guide to Good Manufacturing Practice for Medicinal Products, The GMP Directives 91/356/EEC and 91/341/EEC (1991), European Commission
The Japanese Pharmacopeia, Thirteenth Edition (JP 13) (1995) Ministry of Health and Welfare, Japan
The United States Pharmacopeia, Twenty-third Revision (USP 23) (1995) United States Pharmacopeial Convention, Rockville, MD, USA
Guidelines for Establishing the Specifications and Analytical Procedures of New Drugs, Notification No. 586 (1994) by the director of the Pharmaceuticals and Cosmetic Division, MHW, Japan
ICH Harmonised Tripartite Guideline “Text on Validation of Analytical Procedures”, October 1994, and Draft Consensus Guideline “Extension of the ICH Text on Validation of Analytical Procedures”, November 1995, by the “ICH Steering Committee, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
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© 1997 Springer-Verlag
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Seno, S., Ohtake, S., Kohno, H. (1997). Analytical validation in practice at a quality control laboratory in the Japanese pharmaceutical industry. In: De Bièvre, P., Günzler, H. (eds) Validation in Chemical Measurement. Springer, Berlin, Heidelberg. https://doi.org/10.1007/3-540-27034-5_10
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DOI: https://doi.org/10.1007/3-540-27034-5_10
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Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-540-20788-7
Online ISBN: 978-3-540-27034-8
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