International – PIC/S adopts guidance on PQS risk-based change management, COVID-19 risk assessments

The guidance document, “How to Evaluate and Demonstrate the Effectiveness of the Pharmaceutical Quality System with regard to Risk-Based Change Management,” was originally drafted in 2019 and has now been updated in response to input from industry representatives, the organization said. (RELATED: PIC/S Looks to Help Inspectors Gauge the Effectiveness of a PQS With Risk-Based Change ManagementRegulatory Focus 02 December 2019)

Summarizing the document, PIC/S said its recommendations are intended to provide “practical guidance” for good manufacturing practice (GMP) inspectors for PQS effectiveness and change management, with a goal of “more timely management of risks to product quality and patient safety, as well as better quality and manufacturing performance, continual improvement and innovation.”

PIC/S provided a checklist of lifecycle factors where inspectors should expect change to occur, which includes the introduction of new products, upgrades, changes in materials, test method changes, improvements in manufacturing processes and capacity, quality issue corrections, regulatory changes, improvement initiatives, and addressing PQS signals…