A particular section of ICH- Q10 “Pharmaceutical Quality Systems (PQS)” has left the industry scratching its collective head for several years. How exactly does one demonstrate the effectiveness of a PQS? Solve this problem and reap the rewards of Regulatory relief as listed in Appendix 1 of ICH-Q10.
|4. Demonstrate effective pharmaceutical quality system and product and process understanding, including the use of quality risk management principles (e.g., ICH Q8, ICH Q9, and ICH Q10).||
- increase use of risk-based approaches for regulatory inspections;
Pharmaceutical Inspection Cooperation Scheme (PICs) has just issued a draft recommendation titled “How to Evaluate / Demonstrate the Effectiveness of a Pharmaceutical Quality System concerning Risk-based Change Management” PI 054-01 draft 28NOV2019. Has Industry just been handed a solution by PICs?
The short answer to this question is that it provides a partial answer. ICH Q10 specifies four different elements that constitute the PQS (in addition to two enablers: Knowledge Management and QRM), namely:
- Process Performance and Product Quality Monitoring Systems
- Corrective and Preventative Actions (CAPAs)
- Change Management Systems
- Management Review of Process Performance and Product Quality
The PICs document relies heavily on the principles of Quality Risk Management and Knowledge Management but only has the Change Management in scope: “The purpose of this document is to provide guidance on evaluating and demonstrating the effectiveness of a PQS in relation to risk-based change management. This is in recognition of the fact that the PICs GMP Guide requires companies to demonstrate the effectiveness of their PQS and to apply quality risk management (QRM) principles to change control activities.”
Section 5 of this draft recommendation provides a series of detailed checklists that can be used to interrogate/design a Change Management System under the following headings:
- Change Proposal – Determination of When a Change is Required
- Change Risk Assessment
- Change Planning and Implementation
- Change Review and Effectiveness (pre- and post-closure)
Based on this draft, if your Change Management System meets these requirements, then that …. “should provide sufficient evidence of an effective science- and risk-based change management system.”
Thank you, PICs!
About the Author:
John has more than 23 years of experience providing technical and consulting services in cGMP pharmaceutical and biotechnical environments. John is an experienced QP with several years’ experience releasing both commercial and clinical material to market. John is a Quality Systems SME. He understands FDA and EU regulations, regulatory guidance documents, and ICH guidelines and has applied the knowledge to develop risk based approaches for several applications. John has significant experience in GMP/ISO compliance auditing of manufacturing facilities and supply chain.