International – 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…