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Pharmaceutical Quality System (ICH Q 10 Model) Elements of PQS  Management & Applications
Presentation Outline ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Elements of PQS ,[object Object],[object Object],[object Object],[object Object]
Elements of PQS ,[object Object]
Elements of PQS ,[object Object]
Elements of PQS ,[object Object]
Process Performance, Product Quality Monitoring System ,[object Object]
Product Performance & Product Quality Monitoring System ,[object Object]
Effective Monitoring System ,[object Object],[object Object],[object Object],[object Object],[object Object]
Effective Monitoring System ,[object Object]
Effective Monitoring System ,[object Object],[object Object]
Effective Monitoring System ,[object Object]
Effective Monitoring System ,[object Object]
Effective Monitoring System ,[object Object]
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
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
Corrective Action and Preventive Action (CAPA) System   ,[object Object]
Corrective Action and Preventive Action (CAPA) System   ,[object Object],[object Object]
Corrective Action and Preventive Action (CAPA) System   ,[object Object]
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
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
Change Management System ,[object Object],[object Object],[object Object],[object Object],[object Object]
Change Management System ,[object Object]
Change Management System ,[object Object]
Change Management System ,[object Object],[object Object]
Change Management System ,[object Object],[object Object],[object Object]
Change Management System ,[object Object]
Change Management System ,[object Object]
Change Management System ,[object Object],[object Object]
Change Management System ,[object Object]
Change Management System ,[object Object]
Change Management System ,[object Object]
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
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
Changes Requiring CC  ,[object Object],[object Object],[object Object],[object Object],[object Object]
Changes Requiring CC  ,[object Object],[object Object],[object Object],[object Object],[object Object]
Changes & Deviations ,[object Object],[object Object],[object Object]
Management Review System ,[object Object]
Management Review System ,[object Object],[object Object]
Management Review System ,[object Object]
Management Review System ,[object Object],[object Object],[object Object],[object Object]
Management Review System ,[object Object],[object Object],[object Object],[object Object]
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
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
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Pqs220610.Ppt

  • 1. Pharmaceutical Quality System (ICH Q 10 Model) Elements of PQS Management & Applications
  • 2.
  • 3.
  • 4.
  • 5.
  • 6.
  • 7.
  • 8.
  • 9.
  • 10.
  • 11.
  • 12.
  • 13.
  • 14.
  • 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
  • 17.
  • 18.
  • 19.
  • 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
  • 22.
  • 23.
  • 24.
  • 25.
  • 26.
  • 27.
  • 28.
  • 29.
  • 30.
  • 31.
  • 32.
  • 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
  • 35.
  • 36.
  • 37.
  • 38.
  • 39.
  • 40.
  • 41.
  • 42.
  • 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