Module 3 - Strategic case studies in practice

Pharmaceutical Quality System

3. CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY..............................................................................................7 3.1 Lifecycle Stage Goals .................................................................................................7 3.1.1 Pharmaceutical Development.........................................................................7 3.1.2 Technology Transfer .......................................................................................7 3.1.3 Commercial Manufacturing...........................................................................7 3.1.4 Product Discontinuation ................................................................................7 3.2 Pharmaceutical Quality System Elements ...............................................................7 3.2.1 Process Performance and Product Quality Monitoring System....................8 3.2.2 Corrective Action and Preventive Action (CAPA) System .............................9 3.2.3 Change Management System.......................................................................10 3.2.4 Management Review of Process Performance and Product Quality..........11 4. CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM ..................................................................................................................11 4.1 Management Review of the Pharmaceutical Quality System ...............................11 4.2 Monitoring of Internal and External Factors Impacting the Pharmaceutical Quality System.........................................................................................................12 4.3 Outcomes of Management Review and Monitoring ...............................................12 5. GLOSSARY .............................................................................................................13 Annex 1 :Potential Opportunities to Enhance Science and Risk Based Regulatory Approaches .............................................................................................................16 Annex 2 :Diagram of the ICH Q10 Pharmaceutical Quality System Model .......................17

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