Compendial Requirements for Automated Microbiological Method Validation
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چکیده
Pharmacopeial microbiological tests detect and/or enumerate microbes that replicate in the presence of microbiological media. The challenge presented by adopting modern rapid microbiological methods is determining whether or not they represent the automation of a current compendial method or if they represent an “alternative” to a compendial method. The answer impacts how a firm should qualify and validate the new rapid method and may provide an opportuntiy for a more streamlined validation protocol.
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