Sterility assurance, cleaning validation, and environmental monitoring continue to be hot subjects during pharmaceutical regulatory inspections and aseptic processing industry discussions. This e-book provides best practices of all aspects of this field.
The first article summarizes ASTM E3263-20, Standard Practice For Qualification Of Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues. The second article delves into the seven rules to follow for cleaning verification and validation of multipurpose API plants. Next, the e-book shares a better approach to aseptic process simulation for lyophilized products. The following article uses data to calculate the process capabilities of cleaning processes.
The second half of the e-book provides best practices for different aspects of a sterility assurance program, including the sterility assurance program itself, risk-based environmental monitoring of modern drug product facilities, trending in environmental monitoring programs, and trending environmental monitoring data. Regulatory agencies have written warning letters and observations regarding environmental monitoring and trending programs, so these are key issues for regulatory compliance.