“Risk takes a new dimension” : PIC/S Aide-Memoire

Posted on

Effective 2 April 2012, PIC/S (Pharmaceutical Inspection Cooperation Scheme) published an Aide-Memoire for GMP inspectors on inspections of quality risk management (QRM) systems. The document defines what companies can expect GMP inspectors to be looking for regarding risk management. The document is based on ICH Q9: Risk Management. There are 5 sub-chapters that address:

  1. Overall Systems: does the company use a Quality Risk Management approach, is Senior Management involved in the process, and if there are issues, does Senior Management take action?
  2. Expectations on how QRM should be implemented: Is the process scientific based and does it take prior experience into consideration, and have staff been trained on risk management tools?
  3. Specific Areas and Activities where Implementation of QRM might be expected: QRM would be expected in many areas of the quality system, like, deviations, OOS, CAPA, complaints, change control, sampling and testing, supplier qualification, validation, audit program, etc.
  4. Review of Residual Risk: This addresses assessing the effectiveness of the risk decisions and plans if additional information is forthcoming. This section references ICH Q10 as the model for management review.
  5. Review and improvement of QRM activities: does the company periodically review the QRM system as part of management review and to promote continual improvement of the system?

Read the documentation here.