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.
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.
“The change management system ensures that changes are proposed in a timely manner, proposed changes are formally evaluated, and a decision to accept or reject the proposal is documented. For rejected/voided change proposals, particularly those that relate to mitigation of a quality/safety/efficacy/compliance hazard, the system ensures that the rationales for those decisions are documented and well justified, and that continued risks are adequately managed,” PIC/S said.
Proposed changes in a change management procedure also receive a risk-based classification, which PIC/S noted in the case of major or critical changes “should more substantially address what might go wrong with the proposed change, as well as the potential impact of the change in the context of current process knowledge and the product/facility lifecycle.”
When planning and implementing changes, the risk assessment and risk-based classification should drive any planning, prioritizing, implementation, and considerations for timelines, PIC/S explained. If followed, the guidance should meet a principle in ICH Q12 concerning an effective PQS “that can support the risk-based management of post-approval changes when there is more flexible regulatory oversight of such changes in place.”
“The adherence to the above guidance should provide sufficient evidence of an effective science and risk-based change management system. It should drive risk reduction, where possible, to ensure better quality performance, manufacturing performance, continual improvement and innovation, through adequate and timely management of product quality and patient safety risks,” PIC/S wrote.
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