Demonstration of an effective pharmaceutical quality system (PQS) is a regulatory requirement and is essential if pharmaceutical companies are to achieve the flexible regulatory approaches envisioned by ICH Quality guidelines, the most recent being for post-approval changes as per ICH Q12. While self-inspection has the potential to be a useful tool in achieving this demonstration, the evidence suggests that it is currently under-utilised. Therefore, a research study was performed with the aim of determining how self-inspection might be used to demonstrate the effectiveness of the PQS, the findings of which are outlined in this paper. The research methodologies employed to achieve the research aim included a literature review of the regulatory requirements and guidelines associated with self-inspection and PQS effectiveness and other literature associated with these topics, along with a review of the output of brainstorming studies performed by MSc. Peer Focus Groups at Technological University (TU) Dublin. Finally, three Subject Matter Expert interviews were conducted. Based on the research findings, a roadmap for taking a QRM approach to the self-inspection process was developed, which when applied may demonstrate the effectiveness of the PQS from a Quality Risk Management (QRM) perspective. A checklist was also generated for performing an internal audit of the self-inspection process to verify its effectiveness. Additionally, a self-inspection checklist was generated for each element of the PQS as per ICH Q10:

1. Process Performance and Product Quality Monitoring

2. Change Management

3. Corrective and Preventive Action

4. Management Review



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