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Wide Spectra of Quality Control Part 2

Tham khảo tài liệu 'wide spectra of quality control part 2', kỹ thuật - công nghệ, cơ khí - chế tạo máy phục vụ nhu cầu học tập, nghiên cứu và làm việc hiệu quả | 20 Wide Spectra of Quality Control 6. Conclusion This chapter described the fundamentals and figures of merit for method validation in pharmaceutical analysis. The validation process is to confirm that the method is suited for its intended purpose and to prove the capabilities of the test method. The definitions of method validation parameters are well explained by health authorities. Although the requirements of validation have been clearly documented by regulatory authorities the approach to validation is varied and opened to interpretation and validation requirements differ during the development process of pharmaceuticals. 7. Acknowledgment The authors acknowledge Instituto de Aperfeipoamento Farmaceutico IAF for the scientific discussions and financial support. 8. References AOAC International. 2002 . AOAC Guidelines for Single Laboratory Validation of Chemical Methods for Dietary Supplements and Botanicals Arlington VA. Available from http www.aoac.org Official_Methods slv_guidelines.pdf BRASIL. 2003 . Resolucao RE n.899 de 29 de maio de 2003. Determina a publicacao do Guia para validacao de métodos analíticos e bioanalíticos. Diário Oficial da União Brasilia 02 de junho de 2003. Available from http www. anvisa.gov.br legis resol 2003 re 899_03re.htm CDER Guideline on Validation of Chromatographic Methods. 1994 . Reviewer Guidance of Chromatographic Methods US Food and Drug Administration Centre for Drugs and Biologics Department of Health and Human Services EURACHEM. 1998 . A Laboratory Guide to Method Validation and Related Topics The Fitness for Purpose of Analytical Methods ISBN 0-948926-12-0 Teddington Middlesex United Kigdom. Guidelines for Submitting Samples and Analytical Data for Methods Validation. 1987 . US Food and Drug Administration Centre for Drugs and Biologics Department of Health and Human Services. International Conference on the Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH . Validation of .