Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -9
Question 1:
How should changes be managed in the pharmaceutical development stage?
Answer 1:
Changes in the pharmaceutical development stage should be an inherent part of the process and documented accordingly. The formality of the change management process should be consistent with the stage of pharmaceutical development.
Question 2:
What role does the change management system play during technology transfer activities?
Answer 2:
The change management system should provide management and documentation of adjustments made to the process during technology transfer activities.
Question 3:
Why is a formal change management system important in commercial manufacturing?
Answer 3:
A formal change management system is important in commercial manufacturing to ensure proper oversight and documentation of changes. Oversight by the quality unit provides assurance of appropriate science and risk-based assessments.
Question 4:
What process should changes after product discontinuation go through?
Answer 4:
Any changes after product discontinuation should go through an appropriate change management system to ensure they are properly evaluated and implemented.
Question 5:
How should the formality of the change management process vary across different stages of pharmaceutical development?
Answer 5:
The formality of the change management process should be consistent with the stage of pharmaceutical development. It should be adjusted to suit the specific needs and requirements of each stage, ensuring that changes are managed effectively and appropriately documented.
Question 6:
What drives change within the pharmaceutical industry according to the ICH Q10?
Answer 6:
Innovation, continual improvement, the outputs of process performance and product quality monitoring, and Corrective Action and Preventive Action (CAPA) drive change within the pharmaceutical industry.
Question 7:
Why is it important for a company to have an effective change management system?
Answer 7:
It is important for a company to have an effective change management system to properly evaluate, approve, and implement changes. This ensures that continual improvement is undertaken in a timely and effective manner and provides a high degree of assurance that there are no unintended consequences of the change.
Question 8:
What role does quality risk management play in the change management system?
Answer 8:
Quality risk management should be utilized to evaluate proposed changes. The level of effort and formality of the evaluation should be commensurate with the level of risk associated with the change.
Question 9:
How should proposed changes be evaluated relative to the marketing authorization?
Answer 9:
Proposed changes should be evaluated relative to the marketing authorization, including design space where established, and/or current product and process understanding. An assessment should be made to determine whether a change to the regulatory filing is required under regional requirements.
Question 10:
What should be done after the implementation of a change according to the ICH Q10?
Answer 10:
After implementation, an evaluation of the change should be undertaken to confirm that the change objectives were achieved and that there was no deleterious impact on product quality.
