Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -5
Question 1:
What is management responsible for regarding resource management according to the ICH Q10?
Answer 1:
Management is responsible for determining and providing adequate and appropriate resources (human, financial, materials, facilities, and equipment) to implement and maintain the pharmaceutical quality system and continually improve its effectiveness.
Question 2:
How should resources be allocated according to management responsibilities?
Answer 2:
Resources should be appropriately applied to a specific product, process, or site to ensure their effective utilization and alignment with quality objectives.
Question 3:
What is the role of management in establishing internal communication processes?
Answer 3:
Management is responsible for ensuring appropriate communication processes are established and implemented within the organization. These processes should facilitate the flow of appropriate information between all levels of the company and ensure the appropriate and timely escalation of certain product quality and pharmaceutical quality system issues.
Question 4:
Who is responsible for pharmaceutical quality system governance through management review according to the ICH Q10?
Answer 4:
Senior management is responsible for pharmaceutical quality system governance through management review to ensure its continuing suitability and effectiveness.
Question 5:
What should management assess during management reviews?
Answer 5:
Management should assess the conclusions of periodic reviews of process performance and product quality and of the pharmaceutical quality system.
Question 6:
What is the extent of the pharmaceutical quality system’s responsibility regarding outsourced activities and purchased materials?
Answer 6:
The pharmaceutical quality system, including the management responsibilities, extends to the control and review of any outsourced activities and the quality of purchased materials.
Question 7:
Who is ultimately responsible for ensuring the control of outsourced activities and the quality of purchased materials?
Answer 7:
The pharmaceutical company is ultimately responsible for ensuring processes are in place to assure the control of outsourced activities and the quality of purchased materials.
Question 8:
What processes should be incorporated into the management of outsourced activities and purchased materials according to the ICH Q10?
Answer 8:
The processes should incorporate quality risk management and include assessing the suitability and competence of the other party, defining responsibilities and communication processes, monitoring and reviewing performance, and ensuring incoming ingredients and materials are from approved sources using the agreed supply chain.
Question 9:
What considerations should management take into account when product ownership changes?
Answer 9:
When product ownership changes (e.g., through acquisitions), management should consider the complexity of this and ensure ongoing responsibilities are defined for each company involved and that necessary information is transferred.
Question 10:
How responsibilities and communication processes should be defined for outsourced activities?
Answer 10:
For outsourced activities, responsibilities and communication processes should be defined in a written agreement between the contract giver and contract acceptor.
