Coming April 2017
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, to manage the risk of cross-contamination in order to achieve and maintain an appropriate balance between product quality and operator safety.
The ISPE Baseline Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) 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. The control strategies to manage risk can vary from administrative to full dedication or segregation. To satisfy regulatory requirements, risk management processes are needed in order to determine and document reasonable and acceptable risk when considering multi-product facilities. Typically, some combination of control strategies are necessary.
The revision to the ISPE Baseline Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) Second Edition acknowledges that the overall principles presented in the first edition are still valid, but includes several changes to support ongoing developments:
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