US EditionThe Appropriateness of the ScanRDI® Sterility Testing Method
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The Appropriateness of the ScanRDI® Sterility Testing Method
Introduction Mandated by regulatory requirements such as USP Pharmaceutical Compounding – Sterile Preparations and Current Good Manufacturing Practices (CGMP), sterility testing is a quality control measure for aseptically produced pharmaceutical products. However, the compendial testing method outlined in USP Sterility Tests presents significant statistical, microbiological, and time limitations. The implementation of a robust
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