New PIC/S recommendation for evaluating PQS effectiveness in relation to risk-based change management

December 20, 2019

On November 28, 2019 the Pharmaceutical Inspection Co-Operation Scheme (PIC/S) published a draft Recommendation for Participating Authorities, providing practical guidance for GMP inspectors, on how to evaluate the effectiveness of a pharmaceutical quality system (PQS) in relation to risk-based change management.(1)

The PIC/S GMP Guide requires companies to have an effective PQS and apply quality risk management (QRM) principles to change control activities.

Chapter 1 states:

·         Principle: …there must be ‘a comprehensively designed and correctly implemented Pharmaceutical Quality System incorporating Good Manufacturing Practice and Quality Risk Management. It should be fully documented and its effectiveness monitored’.

·         1.3 ...’the effectiveness of the system is normally demonstrated at the site level’.

·         1.5 ‘Senior management has the ultimate responsibility to ensure an effective Pharmaceutical Quality System is in place...’

·         1.4 (xii) Arrangements [should be] in place ‘for the prospective evaluation of planned changes and their approval prior to implementation…’

Annex 15 states:

·         11.1. ‘The control of change is an important part of knowledge management and should be handled within the pharmaceutical quality system.’

·         11.4. ‘Quality risk management should be used to evaluate planned changes… and to plan for any necessary process validation, verification or requalification efforts.’

·         11.7. ‘…an evaluation of the effectiveness of change should be carried out…’

The recommendation was prepared by the PIC/S Expert Circle on QRM and does not create any new GMP requirements or expectations.  It simply provides inspectors with a tool to support an evaluation of PQS effectiveness in relation to risk-based change management.  It has been designed to help inspectors increase their understanding of what risk-based change management means at a practical level, and then give a framework to help see how effective implementation might be demonstrated by pharmaceutical companies.  The tool provides a checklist approach focusing on:

·         Change proposals – Determination of when a change is needed

·         Change risk assessments

·         Change Planning and implementation

·         Change review and effectiveness

The recommendation is currently a draft that is being applied on a 6-month trial basis, with an expectation that formal adoption will subsequently occur on a revised version following comments on use of the tool by PIC/S participating authorities.

Of more significance than the use of the tool by inspectors over the coming months, is that this move starts to see a shift, albeit a small one, towards greater risk-based regulatory oversight as envisaged in ICH Q10 (Pharmaceutical Quality System) and Q12 (Lifecycle Management). (2)



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