Pharmaceutical Inspection Co-Operation Scheme (PICS) has come out with recommendations on how to demonstrate effectiveness of pharmaceutical quality system (PQS) in relation to risk based change management.
It provides a practical guidance for GMP inspectors when seeking to evaluate the effectiveness of a company’s PQS in relation to risk-based change management.
The document is designed to convey all relevant steps in change related to management process, proposal, assessment, planning, implementation, review and effectiveness checks. It indicates within each step the aspects that render PQS to be effective in that area.
The pharma industry now views that 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. Now PICS wants companies to demonstrate effectiveness of their PQS and to apply quality risk management (QRM) principles to change control activities.
PICS sees the need for a comprehensively designed implemented PQS incorporating GMP and QRM which should be fully documented and its effectiveness monitored. It sees the need that the effectiveness of the system demonstrated at the site level.
The senior management has the ultimate responsibility to ensure an effective PQS is in place and arrangements are in place during a prospective evaluation of planned changes and its approval prior to implementation.
With regards to change management, PICS noted that it is an important part of knowledge management and should be handled within the PQS. Quality risk management should be used to evaluate planned changes and to plan for any necessary process validation, verification or re-qualification efforts.
The assessment by the pharmaceutical manufacturer where the level of rigor, effort and documentation should be commensurate with the risk assessments adequately to assess potential risks and benefits of changes to product quality, safety and efficacy.
The document notes that the application by a pharmaceutical company will need to provide evidence of the effectiveness of the PQS at that company in relation to risk-based change management.
If such a risk based change management system were in place within the company’s PQS, it should lead to the timely management of risks to product quality and patient safety, as well as better quality and manufacturing performance, continual improvement and innovation.
Further PICS points out that the GMP requirements are also important in the context of ICH Q10, which sets out the potential for risk-based regulatory oversight for companies which demonstrate that an effective PQS is in place. It will be useful in supporting implementation of the principles and concepts in the ICH Q12 guideline, which is currently under development at ICH in relation to post-approval change management.
This document applies to GMP inspections of manufacturers of medicinal products and active pharmaceutical ingredients. In this regard, it provides triggers for changes and the related evidence are clearly documented.
These cover upgrades to equipment or facilities, improvements in raw materials, manufacturing performance and consistency to reduce variability, improve yield among others. Besides enhancements in manufacturing capacity, corrections of quality issues, address signals from the PQS such as deviations, complaints or adverse events, corrective action and preventative action (CAPA), product quality review, operational review metrics, management review, new regulations, compliance gaps implementing innovation or continual improvement initiatives.