The Appropriateness of the ScanRDI® Sterility Testing Method
Introduction
Mandated by regulatory requirements such as USP <797> 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 <71> Sterility Tests presents significant statistical, microbiological, and time limitations. The implementation of a robust quality assurance program and the adoption of rapid sterility testing methods are essential to overcome such limitations. Read More >