Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -7
Question 1:
Why is it important for pharmaceutical companies to implement a system for monitoring process performance and product quality?
Answer 1:
It is important for pharmaceutical companies to implement such a system to ensure a state of control is maintained. This system provides assurance of the continued capability of processes and controls to produce a product of desired quality and helps identify areas for continual improvement.
Question 2:
How should quality risk management be utilized in establishing the control strategy for the monitoring system?
Answer 2:
Quality risk management should be used to establish the control strategy. This involves considering parameters and attributes related to various aspects such as drug substance and drug product materials, facility and equipment operating conditions, in-process controls, finished product specifications, and associated monitoring and control methods and frequencies. The control strategy should facilitate timely feedback/feedforward and appropriate corrective and preventive actions.
Question 3:
What tools should be provided by the monitoring system for measurement and analysis?
Answer 3:
The monitoring system should provide tools for the measurement and analysis of parameters and attributes identified in the control strategy. This may include data management and statistical tools.
Question 4:
How does the monitoring system contribute to continual improvement activities?
Answer 4:
The monitoring system identifies sources of variation affecting process performance and product quality, which can inform potential continual improvement activities aimed at reducing or controlling variation.
Question 5:
What types of feedback on product quality should be included in the monitoring system?
Answer 5:
The monitoring system should include feedback on product quality from both internal and external sources, such as complaints, product rejections, non-conformances, recalls, deviations, audits, and regulatory inspections and findings.
Question 6:
How can knowledge generated during pharmaceutical development be utilized in manufacturing?
Answer 6:
Knowledge generated during pharmaceutical development, including process and product knowledge, can be used to establish a control strategy for manufacturing.
Question 7:
What role does monitoring during scale-up activities play in technology transfer?
Answer 7:
Monitoring during scale-up activities can provide a preliminary indication of process performance and the successful integration into manufacturing. The knowledge obtained during transfer and scale-up activities can be useful in further developing the control strategy.
Question 8:
What should be continued during product discontinuation in terms of monitoring?
Answer 8:
During product discontinuation, monitoring such as stability testing should continue until the completion of the studies. Additionally, appropriate action on marketed product should continue to be executed according to regional regulations.
Question 9:
How can the information gathered during commercial manufacturing contribute to the control strategy?
Answer 9:
The information gathered during commercial manufacturing can provide valuable insights into process performance and product quality, which can inform and refine the control strategy to ensure continued product quality and process control.
Question 10:
Why is it important to continue monitoring even after manufacturing ceases during product discontinuation?
Answer 10:
Continuing monitoring during product discontinuation, such as stability testing, ensures that any changes in product quality or stability are identified and addressed, maintaining the integrity of the product until the end of its lifecycle. Additionally, it ensures compliance with regulatory requirements regarding product discontinuation.
