Whitepaper: Sterility testing – difficult products
This whitepaper considers sterility testing to support pharmacopoeial monographs with an emphasis on products that are difficult to test or validate.
Sterility test method validations can be as difficult as they are important, so understanding practical approaches, especially for products where pharmacopoeial methods cannot be readily applied, can be extremely beneficial. This whitepaper considers the difficulties associated with sterility test method validation, essential validation documents, guidance on training requirements and more.
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Analytical techniques, Biologics, Biopharmaceuticals, Bioprocessing, Biosimilars, Environmental Monitoring, Gene therapy, Good Manufacturing Practice (GMP), Manufacturing, Medical Devices, Microbiology, Outsourcing, Proteomics, QA/QC, Regulation & Legislation, Research & Development (R&D), Stem Cells, Vaccines