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The ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) Second Edition provides a scientific risk-based approach, based on ICH Q9 Quality Risk Management, for managing the risk of cross-contamination within shared facilities. Risk management processes should be used to determine and document reasonable and acceptable risk, in order to maintain product quality and operator safety and to satisfy regulatory requirements. This Guide provides a process that allows manufacturers to assess risk and determine where control strategies are necessary to meet acceptable limits for cross-contamination. The control strategies to manage risk can vary from administrative to full dedication or segregation. Typically, some combination of control strategies may be necessary. This Guide is intended to provide a 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.
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