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

Regulatory NewsRegulatory News
| 16 July 2021 | By Jeff Craven 

Two new guidance documents released by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) have come into force this week concerning the effectiveness of pharmaceutical quality systems (PQS) and COVID-19 risk assessment for on-site inspections.

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 Management, Regulatory 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.
“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.
COVID-19 risk assessment during inspections
PIC/S is also now following a COVID-19 risk assessment guidance document for on-site GxP inspections. The risk assessment should be performed during the inspection planning phase together with the site prior to the actual inspection, PIC/S said.
If there is an un-announced inspection, “an individual bespoke risk assessment must be completed to take account of the more complex risks – this risk assessment should not be used for these types of inspections,” the organization wrote.
The guidance document contains commonsense guidelines for limiting exposure to COVID-19 for inspectors, such as social distancing, reducing the number of hosts for a visit, minimizing the amount of time on site, and using alternative methods of communicating like video conferencing in situations where a large number of people are required to attend. PIC/S also recommends inspectors remove all jewelry prior to the visit, wear waterproof shoes and clothing that can withstand a hot washing cycle (60 degrees Celsius), and wipe down their workstation and equipment at the beginning and end of the day.
Inspectors are required to follow national guidelines for face coverings and should follow general guidelines for COVID-19 sanitation. In general, inspectors should limit their time in communal areas at the inspection site and in the hotel where they are staying. “The operations covered by this assessment include all inspections under the GxP routine inspection programme; the same principles should be applied for inspectorate meetings held at offices where inspectors will need to travel and/or stay overnight,” PIC/S wrote.
PIC/S: COVID-19 Risk Assessment for National Routine On-Site InspectionsHow to Evaluate and Demonstrate the Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management


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