This document outlines the key elements of a Pharmaceutical Quality System (PQS) as defined in ICH Q10, including process performance and product quality monitoring, corrective and preventive action systems, change management systems, and management review. It discusses how each element should be applied throughout the product lifecycle in a manner appropriate to each stage, with the goal of continually improving product quality.

1. Pharmaceutical Quality System (ICH Q 10 Model) Elements of PQS Management & Applications

15. Applications of Monitoring System Monitoring during scale-up activities can provide a preliminary indication of process performance and successful integration into manufacturing. Knowledge obtained during transfer and scale-up activities can be used to further developing the control strategy. Process and product knowledge generated and process and product monitoring conducted throughout development can be used to establish a control strategy for manufacturing. Technology Transfer Pharmaceutical Development

16. Applications of Monitoring System Once manufacturing ceases, monitoring such as stability studies should continue to completion of studies. Appropriate action of marketed product should continue to be executed according to regional regulations. A well-defined system for process performance and product quality monitoring should be applied to assure performance within a state of control and to identify improvement areas. Product Discontinuation Commercial Manufacturing

20. Applications of CAPA System CAPA can be used as an effective system for feedback, feed forward and continual improvement. Product process variability is explored. CAPA methodology is useful where Corrective action and Preventive actions are incorporated into interactive design and development process. Technology Transfer Pharmaceutical Development

21. Applications of CAPA System CAPA should continue after the product is discontinued. The impact on product remaining on the market should be considered, as well as other products that might be affected. CAPA can be used, and effectiveness of the actions should be evaluated . Product Discontinuation Commercial Manufacturing

33. Applications of Change Management System The change management system should provide management and documentation of adjustments made to the process during technology transfer activities. Change is an inherent part of the development process and should be documented; the formality of the change management process should be consistent with the stage of pharmaceutical development. Technology Transfer Pharmaceutical Development

34. Applications of Change Management System Any changes after product discontinuation should go through an appropriate change management system. A formal change management system should be in place for commercial manufacturing. Oversight by the quality unit should provide assurance of appropriate science-and risk-based assessments. Product Discontinuation Commercial Manufacturing

43. Applications of Management Review System Aspects of management review should be performed to ensure the developed product and process can be manufactured at commercial scale. Aspects of management review can be performed to ensure adequacy of the product and process design. Technology Transfer Pharmaceutical Development

44. Applications of Management Review System Management review should include such items as product stability and product quality complaints. Management review should be a structured system, as described above, and should support continual improvement Product Discontinuation Commercial Manufacturing

45. QUESTIONS?

46. THANKS