Einsatz einer Risikoanalyse zur Reduzierung des mikrobiologischen Testumfangs bei Ausgangsstoffen und Endprodukten Reduction of the Extent of Microbiological Testing using Risk Analysis Based on the ICH Q6A Guidance „Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances“ which includes decision trees for a possible reduction of microbiological testing in drug substances and excipients, as well as in finished products, a detailed procedure is presented how to evaluate microbiological risks and to establish a skip lot testing program. Key words Mikrobiologische Risikoanalyse von Ausgangsstoffen und Endprodukten • Stichprobenprüfung • Test-Reduktion |
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pharmind 2007, Nr. 3, Seite 363
