ISPE Releases Baseline Guide: Risk-Based Manufacture of Pharmaceutical Products (Second Edition)
ISPE announced the release of their latest guidance document, ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Second Edition). This guide provides a scientific, risk-based approach (based on ICH Q9 Quality Risk Management) for managing the risk of cross-contamination within shared facilities.
“The use of multi-product facilities for the production of pharmaceutical products requires an in-depth understanding of the products, the facilities, the processes, and the equipment and the risks posed by this combination,” said Stephanie Wilkins, Guidance Team Co-lead. “This Baseline Guide was created to assist manufacturers in assessing and controlling the risk of cross contamination posed by their combination of products, facilities, processes, and equipment so they are compliant with regulations and can confidently deliver products to patients in a safe, timely, and cost-effective manner.”
This ISPE Baseline Guide: Risk-Based Manufacture of Pharmaceutical Products (Second Edition) provides a process that allows manufacturers to assess risk and determine where control strategies are necessary to meet acceptable limits for cross-contamination. It is also intended to offer a more consistent approach on setting acceptable limits to assess the potential of cross-contamination, thus enabling implementation of appropriate controls to facilitate safe and affordable drug product manufacturing.
The FDA and EMA were actively involved and reviewed the document prior to publication. The second edition includes changes to support recent ongoing developments. Content has been added to support significant changes in regulations and the application of these regulations. Some information has also been reorganized so that the layout of the guide aligns with the ICH Q9 process. In addition, the application example has been updated based on a heightened understanding and experience with Quality Risk Management, specifically with risk assessments for cross-contamination.