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, Process Validation in Manufacturing of Biopharmaceuticals, Taylor and Francis, Boca Raton, FL 2005, pp. 13 50 . 21. US Food and Drug Administration. assistance for industry: Q10 first-rate methods strategy case study pharmaceutical cGMP rules FDA, Rockville, MD, September 200622. US Food and Drug Administration. Guidance for Industry. PAT—A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance. Pharmaceutical cGMPs,Rockville, Pharmaceutical cGMPs. MD, 2004 Sept. , 1–21.
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