Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -8
Question 1:
What types of actions should be implemented through the CAPA system according to the ICH Q10?
Answer 1:
The CAPA system should implement corrective actions and preventive actions resulting from the investigation of various issues such as complaints, product rejections, non-conformances, recalls, deviations, audits, regulatory inspections and findings, and trends from process performance and product quality monitoring.
Question 2:
What is the objective of the investigation process within the CAPA system?
Answer 2:
The objective of the investigation process within the CAPA system is to determine the root cause of the identified issues. A structured approach to the investigation process should be used to achieve this objective.
Question 3:
How should the level of effort, formality, and documentation of the investigation be determined?
Answer 3:
The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9. This means that the investigation process should be tailored to the specific risk associated with the issue being addressed.
Question 4:
How is the CAPA methodology utilized in pharmaceutical development?
Answer 4:
In pharmaceutical development, the CAPA methodology is useful for exploring product or process variability. Corrective actions and preventive actions can be incorporated into the iterative design and development process to improve product and process understanding.
Question 5:
Why is it important for the CAPA process to continue even after product discontinuation?
Answer 5:
Continuing the CAPA process after product discontinuation ensures that any remaining issues are addressed appropriately. The impact on products remaining on the market should be considered, as well as potential impacts on other products that might be affected.
Question 6:
What is the purpose of the management review of the pharmaceutical quality system?
Answer 6:
The purpose of the management review of the pharmaceutical quality system is to ensure its effectiveness by measuring achievement of objectives and assessing performance indicators, thereby facilitating continual improvement.
Question 7:
What are some examples of performance indicators used to monitor the effectiveness of processes within the pharmaceutical quality system?
Answer 7:
Examples of performance indicators include processes such as complaints, deviations, corrective and preventive actions (CAPA), change management, feedback on outsourced activities, self-assessment processes including risk assessments, trending, audits, and external assessments such as regulatory inspections and customer audits.
Question 8:
What factors should management monitor that can impact the pharmaceutical quality system?
Answer 8:
Management should monitor factors such as emerging regulations, guidance, and quality issues; innovations that might enhance the pharmaceutical quality system; changes in the business environment and objectives; and changes in product ownership.
Question 9:
What are some potential outcomes of the management review and monitoring process?
Answer 9:
Potential outcomes include improvements to the pharmaceutical quality system and related processes, allocation or reallocation of resources and personnel training, revisions to quality policy and quality objectives, and documentation and communication of the results of the review and actions taken, including escalation of appropriate issues to senior management.
Question 10:
Why is documentation and effective communication of the results of the management review important?
Answer 10:
Documentation and effective communication of the results of the management review are important to ensure transparency, accountability, and alignment across the organization. It facilitates understanding of the findings and actions taken, encourages participation in improvement initiatives, and enables timely resolution of issues.
