PIC/S last week published a draft recommendation offering guidance for 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 FDA, 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. Learn More