ISPE Baseline Guide: Risk-Based Manufacture of Pharmaceutical Products (Second Edition)

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 Baseline Guide Volume 7 Cover

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:

  1. Information has been added to support some significant changes in regulations and the application of regulations. These include:
    • Updating EU GMPs relative to managing the risk of cross-contamination.
    • Guidance provided by the EMA to pharmaceutical industry on how to set health-based limits that would be used in the risk management process to determine if shared facilities can be used. This guidance also states “PDE and ADE are effectively synonymous”.
    • ICH issued M7 “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” which sets a threshold of toxicological concern (TTC) for mutagenic impurities in drug substances and drug products when there is insufficient data to calculate the acceptable limit.
    • Adoption by U.S. and EU regulators of a “life cycle” approach to process validation incorporating stages of process design, process qualification, and continued process verification. The Process Validation Lifecycle recognizes that validation is an ongoing control strategy to manage risks and maintain process control. The concept of ongoing assurance of cleaning process efficacy is one of the keys to control the cross-contamination outlined in this guide.
    • Implementing risk-based approaches to managing the risk of cross-contamination and sharing some lessons learned.
  2. Some information has been relocated, in order to align better with the ICH Q9 process.
  3. Updated example, in the appendix, based on an increased understanding and more experience with Quality Risk Management, and more specifically with risk assessments for cross-contamination.

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