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PIC/S: Final Recommentation Document on Risk-Based Change Management

PIC/S: Final Recommentation Document on Risk-Based Change Management

On 15 July 2021 the PIC/S recommendation document How to Evaluate and Demonstrate the Effectiveness of the Pharmaceutical Quality System with regard to Risk-Based Change Management (PI 054-1) came into force. The document provides practical guidance and covers all relevant steps in change management process – change proposal, change assessment, change planning and implementation, change review and effectiveness checks.

No new GMP requirements are introduced, as the aspects addressed are already layed down in the PIC/S GMP Guide. This recommendation document offers a perspective on the practical „how to do“.  It is applicable to medicinal products and API manufacturing.

Originally set up for inspectors, the checklists included can be useful for manufacturers, too. They help to define internal change management procedures and practices. The key points to consider are summarized for:

  • Change Proposals -Determination of when a change is needed
  • Change Planning and Implementatiohange Risk Assessments
  • Change Review and Effectiveness

According to PIC/S, adhering to the  guidance should  provide  sufficient  evidence  of  an effective science and risk-based change management system.


PIC/S: PI 054-1