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Current Global GMP Status and Trends With Focus …

Current Global GMP Status and Trends With Focus on EU & PIC/S. JPMA Annual Meeting, Tokyo & Osaka, September 2012. Stephan R nninger Pharma Medicines Technical Operations Global Quality & Compliance, F. Hoffmann-La Roche Ltd GMP in PIC/S and the European Union Trend in GMP Inspections Good Distribution Practice Conclusion 2. GMP in PIC/S and the European Union Trend in GMP Inspections Good Distribution Practice Conclusion 3. EU is Not A Synonym for a Union'. 4. The Legal Basis of the GMPs in Europe Primary Law Treaty establishing EU. (medicines: Article168(4)(c)). Art 168. Falsified Medicines amending Community code Directive Medicinal products for human use Secondary Law (2011/62/EC) (2001/83/EC).

Current Global GMP Status and Trends With Focus on EU & PIC/S JPMA Annual Meeting, Tokyo & Osaka, September 2012 Dr.-Ing. Stephan Rönninger Pharma Medicines Technical Operations Global Quality & Compliance , F. Hoffmann-La Roche Ltd

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Transcription of Current Global GMP Status and Trends With Focus …

1 Current Global GMP Status and Trends With Focus on EU & PIC/S. JPMA Annual Meeting, Tokyo & Osaka, September 2012. Stephan R nninger Pharma Medicines Technical Operations Global Quality & Compliance, F. Hoffmann-La Roche Ltd GMP in PIC/S and the European Union Trend in GMP Inspections Good Distribution Practice Conclusion 2. GMP in PIC/S and the European Union Trend in GMP Inspections Good Distribution Practice Conclusion 3. EU is Not A Synonym for a Union'. 4. The Legal Basis of the GMPs in Europe Primary Law Treaty establishing EU. (medicines: Article168(4)(c)). Art 168. Falsified Medicines amending Community code Directive Medicinal products for human use Secondary Law (2011/62/EC) (2001/83/EC).

2 API Excipients Art 40. Deleg ated Act to ada pt prov for GM isions GMP Directive Art 13. Clinical Trials Directive P for A. PIs for medicinal products and IMP. (2001/20/EC). (2003/94/EC; API as starting material). EudraLex Vol 4 (EU GMP). GMP-Guidelines based on Dir 2003/94/EC and 91/411/EEC. (EudraLex Vol. 4: EU-GMP'). Regulatory statutes Part I Part II Part III Annexes Other Documents Medicinal Product Active substances GMP related Annexes related to GMP. (= drug products) as starting material documents ICH Q7 ICH Q9, ICH Q10, SMF, GDP guideline;. Chapter 1-9 Annex 1-17;19. & ICH Q9 principles Batch certificate, API conf. comp. of Scope: red: medicinal product, blue: API. 5. EudraLex Vol.

3 4: EU-GMP EudraLex Vol 4 (EU GMP). GMP-Guidelines Part I Part I Part II. based on Dir 2003/94/EC and 91/411/EEC. (EudraLex Vol. 4: EU-GMP'). Part III Annexes Other Documents Medicinal Product Active substances GMP related Annexes related to GMP. (= drug products) as starting material documents ICH Q7 ICH Q9, ICH Q10, SMF, GDP guideline;. Chapter 1-9 Annex 1-17;19. & ICH Q9 principles Batch certificate comp. of Scope: red: medicinal product, blue: API. Basic Requirements for Medicinal Products Chapter 1 Pharmaceutical Quality System General: Chapter 2 Personnel Implementation of the principles of Chapter 3 Premise and Equipment ICH Q8/11,9,10 in the GMPs Specific: Chapter 4 Documentation - QRM principles (Ch 1).

4 - Dedicated facilities (Ch 3/5). Chapter 5 Production - Contract manufacturing (Ch 5). - QbD & QRM (Ch 5). Chapter 6 Quality Control - Transfer Analytical methods (Ch. 6). - Supplier auditing (Ch 9). Chapter 7 Outsourced Activities (former Contract Manufacture and Analysis). Chapter 8 Complaints and Product Recall Chapter 9 Self Inspection 6. EudraLex Vol. 4: EU-GMP EudraLex Vol 4 (EU GMP). GMP-Guidelines Part I Part I Part II. based on Dir 2003/94/EC and 91/411/EEC. (EudraLex Vol. 4: EU-GMP'). Part III Annexes Other Documents Medicinal Product Active substances GMP related Annexes related to GMP. (= drug products) as starting material documents ICH Q7 ICH Q9, ICH Q10, SMF, GDP guideline.

5 Chapter 1-9 Annex 1-17;19. & ICH Q9 principles Batch certificate comp. of Scope: red: medicinal product, blue: API. Chapter 1: Pharmaceutical Quality ICH Q10: Pharmaceutical Quality System (effective 31. Jan 2013) System Changes are to align with ICH Q10 Management Responsibility and implement QRM principles Continual Improvement of process PQS facilitator to manage GMP performance and product quality - Appropriately qualified and trained Pharmaceutical Quality System Elements personnel - Process Performance and Product Quality - Adequate premises and space Monitoring System - Suitable equipment and services - Corrective Action and Preventive Action (CAPA). - Correct materials System - Containers and labels - Change Management System - Approved procedures and instructions - Management Review of Process Performance - Suitable storage and transport and Product Quality - Quality Control Continual Improvement of the PQS.

6 - Product Quality Review More than Q10 7. EudraLex Vol. 4: EU-GMP EudraLex Vol 4 (EU GMP). GMP-Guidelines Part II Part I Part II. based on Dir 2003/94/EC and 91/411/EEC. (EudraLex Vol. 4: EU-GMP'). Part III Annexes Other Documents Medicinal Product Active substances GMP related Annexes related to GMP. (= drug products) as starting material documents ICH Q7 ICH Q9, ICH Q10, SMF, GDP guideline;. Chapter 1-9 Annex 1-17;19. & ICH Q9 principles Batch certificate comp. of Scope: red: medicinal product, blue: API. Basic Requirements for Active Substances used as Starting Materials = ICH Q7 & ICH Q9 principles (added as chapter ). Other ICH documents related to APIs - ICH Q 9: APIs in scope - ICH Q10: Refers to ICH Q7 as a foundation - ICH Q8(R2): Part II of ICH Q8 describes the development principles - ICH Q11: Selection of API starting material and source materials (Chapter ): approved regulatory filing defines when to start GMP.

7 - Q&A on Q7: Under discussion in ICH 8. EudraLex Vol. 4: EU-GMP EudraLex Vol 4 (EU GMP). GMP-Guidelines Part III Part I Part II. based on Dir 2003/94/EC and 91/411/EEC. (EudraLex Vol. 4: EU-GMP'). Part III Annexes Other Documents Medicinal Product Active substances GMP related Annexes related to GMP. (= drug products) as starting material documents ICH Q7 ICH Q9, ICH Q10, SMF, GDP guideline;. Chapter 1-9 Annex 1-17;19. & ICH Q9 principles Batch certificate comp. of Scope: red: medicinal product, blue: API. GMP related documents Site Master File (SMF). ICH Q9 Quality Risk Management ICH Q10 Note for Guidance on Pharmaceutical Quality System Internationally harmonised requirements for batch ( MRA Batch Certificate').

8 Template for the 'written confirmation' for active substances exported to the European Union for medicinal products for human use 9. EudraLex Vol. 4: EU-GMP EudraLex Vol 4 (EU GMP). GMP-Guidelines Annexes with Human Medicines in scope Part I Part II. based on Dir 2003/94/EC and 91/411/EEC. (EudraLex Vol. 4: EU-GMP'). Part III Annexes Other Documents Medicinal Product Active substances GMP related Annexes related to GMP. (= drug products) as starting material documents ICH Q7 ICH Q9, ICH Q10, SMF, GDP guideline;. Chapter 1-9 Annex 1-17;19. & ICH Q9 principles Batch certificate comp. of Scope: red: medicinal product, blue: API. Annex 1 Manufacture of Sterile Medicinal Products Annex 2 Manufacture of Biological Medicinal Products for Human Use Annex 3 Manufacture of Radiopharmaceuticals Annex 7 Manufacture of Herbal Medicinal Products Annex 8 Sampling of Starting and Packaging Materials Annex 9 Manufacture of Liquids.

9 Creams and Ointments Annex 10 Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation Annex 11 Computerised Systems Annex 12 Use of Ionising Radiation in the Manufacture of Medicinal Products Annex 13 Manufacture of Investigational Medicinal Products Annex 14 Manufacture of Products derived from Human Blood or Human Plasma Annex 15 Qualification and validation Annex 16 Certification by a Qualified person and Batch Release Annex 17 Parametric Release Annex 19 Reference and Retention Samples Implementation of the principles of Annex 20 Quality Risk Management ICH Q8/11,9,10 in the GMPs CPV(15), RTRT (17), PAT (19)10. In PIC/S GMPs EudraLex Vol. 4: EU-GMP EudraLex Vol 4 (EU GMP).

10 GMP-Guidelines Other Documents Related to GMP Part I Part II. based on Dir 2003/94/EC and 91/411/EEC. (EudraLex Vol. 4: EU-GMP'). Part III Annexes Other Documents Medicinal Product Active substances GMP related Annexes related to GMP. (= drug products) as starting material documents ICH Q7 ICH Q9, ICH Q10, SMF, GDP guideline;. Chapter 1-9 Annex 1-17;19. & ICH Q9 principles Batch certificate comp. of Scope: red: medicinal product, blue: API. Compilation of Community Procedures on Inspections and Exchange of Information updated to include new EU formats and procedures - A collection of GMP/GDP inspection-related procedures GMP & GDP Inspections Rapid Alert system: Quality defects, Recalls, Suspected defects Exchange of information among inspectorates Quality systems within the inspectorates themselves Format of inspection reports Follow up on quality defects Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03).


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