Risk-MaPP provides a scientific risk-based approach, based on ICH Q9 Quality Risk Management, to manage the risk of cross contamination in order to achieve and maintain an appropriate balance between product quality and operator safety. Find this definition and more in the ISPE Glossary of Pharmaceutical Technology.
The Risk-MaPP approach to Quality Risk Management is documented in the ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP). If you are involved with multi-product facilities, this document is an essential tool for you.
Opportunities to understand the “why”, “what”, and “how to use” the Guide include conferences, webinars, training, and white papers. Educational sessions pertaining to Risk-MaPP will focus on use of the logic diagram, how health based limits are developed, setting cleaning validation limits, risk assessments for cross contamination, and formulating a Quality Risk Management Plan as part of a Quality System.
ISPE has created an FAQ document dedicated to frequently asked questions on Risk-MaPP and its approach to managing the risk of cross contamination. The first version of this document highlights questions around limit setting which were raised during the some of the launch sessions in the fall. This document will be updated as needed to include other frequent questions as they arise. This is a must have complement to your Risk-MaPP guide.
Knowledge Briefs and White Papers