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Regulatory Focus™ > News Articles > 2019 > 12 > PIC/S Looks to Help Inspectors Gauge the Effectiveness of a PQS With Risk-Based Change Management

PIC/S Looks to Help Inspectors Gauge the Effectiveness of a PQS With Risk-Based Change Management

Posted 02 December 2019 | By Zachary Brennan 

PIC/S Looks to Help Inspectors Gauge the Effectiveness of a PQS With Risk-Based Change Management

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) last week published a draft recommendation offering guidance for good manufacturing practice (GMP) inspectors seeking to evaluate the effectiveness of a company’s pharmaceutical quality system (PQS) in relation to risk-based change management.

The 8-page draft recommendation, which is not open for comments, will be applied on a 6-month trial basis by PIC/S participating authorities, which include the US Food and Drug Administration and other regulators across Europe, Australia, Canada, South Africa, Turkey, Iran, Argentina and more.

The document was created in recognition of the fact that the PIC/S GMP Guide requires companies to demonstrate the effectiveness of their PQS and to apply quality risk management (QRM) principles to change control activities.

“The document covers all relevant steps in the change management process – from change proposal, change assessment, change planning & implementation, through to change review and effectiveness checks, and it indicates within each step the aspects that render the PQS to be effective in that area,” PIC/S explains.

For instance, the document discusses common lifecycle factors that trigger change, including upgrades to equipment or facilities, improvements in raw materials or manufacturing performance and consistency and enhancements in manufacturing capacity, among others.

PIC/S also explains how the document should be viewed in light of ICH Q10, which explains the potential for risk-based oversight of pharmaceutical companies that have instituted an effective PQS.

Despite the use of ICH Q10 over the last 10 years, PIC/S noted that the "ongoing continual improvement has probably not been realised to a meaningful extent. The PIC/S QRM Expert Circle, being well-placed to focus on the QRM concepts of the GMPs and of ICH Q10, is seeking to train GMP inspectors on what a good risk-based change management system can look like within the PQS, and how to assess the level of effectiveness of the PQS in this area,” PIC/S added.

Draft PIC/S Recommendation on How to Evaluate / Demonstrate the Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management

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