Pharmaceutical Quality by Design Development[通过设计与开发药物质量](PPT-66).ppt

2006.08.22. Pogány - Dar es Salaam */66 Manufacturing Process Development An assessment of the ability of the process to reliably produce a product of the intended quality e.g., the performance of the manufacturing process under different operating conditions, at different scales, or with different equipment can be provided. Unsatisfactory processes must be modified and improved until a validation exercise proves them to be satisfactory. An understanding of process robustness can be useful in risk assessment and risk reduction. 2006.08.22. Pogány - Dar es Salaam */66 The remaining steps Pharmaceutical equivalence and bioequivalence with innovator product has been demonstrated Production batches validated Compilation of the dossier for prequalification Prequalification procedure GMP inspection Listing the FPP on the PQ website 2006.08.22. Pogány - Dar es Salaam */66 Main points again Development pharmaceutics is an essential part of applications for prequalification. Desk research gives valuable design and development information. The specifications of an API are finalized during pharmaceutical development studies. FPP design, characterization and selection should follow a scientific methodology. Manufacturing process design and optimization identifies the critical attributes whose control leads to the batch-to-batch consistency of quality. 2006.08.22. Pogány - Dar es Salaam */66 THANK YOU * * * * * FOURTH INVITATION FOR EXPRESSION OF INTEREST (EOI) (Artemisinin based Antimalarial Products) May 2005 In the context of facilitating access to Artemisinin based combination antimalarial drug products, Roll Back Malaria (RBM) Department of the World Health Organization, UNICEF and UNDP are inviting Expressions of Interest from manufacturers of pharmaceutical products in respect to the provision of drugs for the management of malaria. The World Bank is in support of this effort. This fourth invitation is published in order to increase the range of possible product