Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -10
Question 1:
What is the purpose of management review regarding process performance and product quality?
Answer 1:
The purpose of management review regarding process performance and product quality is to provide assurance that these aspects are managed effectively over the lifecycle of the product.
Question 2:
What factors should be included in the management review system according to the ICH Q10?
Answer 2:
The management review system should include the results of regulatory inspections and findings, audits, and other assessments, as well as commitments made to regulatory authorities. It should also encompass periodic quality reviews, which may involve measures of customer satisfaction, conclusions of process performance and product quality monitoring, and the effectiveness of process and product changes, including those arising from corrective action and preventive actions. Additionally, any follow-up actions from previous management reviews should be addressed.
Question 3:
What actions should be identified by the management review system?
Answer 3:
The management review system should identify appropriate actions such as improvements to manufacturing processes and products, provision, training and/or realignment of resources, and the capture and dissemination of knowledge.
Question 4:
How does the size and complexity of the company influence the management review process?
Answer 4:
Depending on the size and complexity of the company, the management review process may consist of a series of reviews at various levels of management. This process should include a timely and effective communication and escalation process to raise appropriate quality issues to senior levels of management for review.
Question 5:
Why is it important to include measures of customer satisfaction in the periodic quality reviews?
Answer 5:
Including measures of customer satisfaction, such as product quality complaints and recalls, in the periodic quality reviews provides valuable insights into the performance and quality of products from the perspective of end-users. This feedback is crucial for identifying areas of improvement and ensuring that customer needs and expectations are met.
Question 6:
What aspects of management review are important in pharmaceutical development?
Answer 6:
In pharmaceutical development, aspects of management review should ensure the adequacy of the product and process design.
Question 7:
Why is management review important during technology transfer?
Answer 7:
During technology transfer, management review is important to ensure that the developed product and process can be successfully manufactured at a commercial scale.
Question 8:
How should management review be structured in commercial manufacturing?
Answer 8:
In commercial manufacturing, management review should be a structured system that supports continual improvement, as described earlier in the ICH Q10.
Question 9:
What specific items should be included in management review during product discontinuation?
Answer 9:
During product discontinuation, management review should include items such as product stability and product quality complaints.
Question 10:
How do these aspects of management review contribute to overall quality management?
Answer 10:
These aspects of management review contribute to overall quality management by ensuring that key aspects of product development, manufacturing, and discontinuation are systematically evaluated, monitored, and improved upon. They help maintain product quality, compliance with regulations, and customer satisfaction throughout the product lifecycle.
