Revision of Chapter 7 Contract Manufacture and Analysis

Transcription

1 Revision of Chapter 7 Contract Manufacture and Analysis GMP & Market Compliance Information Day, Catherine Neary Inspector Date Insert on Master Slide Slide 1

2 Overview Purpose of revision to Chapter 7 Comparison of ICH & EU GMP Requirements Impact Assessment & Implications of new revision Next Steps 14 October 2010 Slide 2

3 Revision of Chapter 7 EU GMP (1) Contract Manufacture & Analysis EMA concept paper published in October edural_guideline/2009/10/wc pdf Draft revision at the finalisation stage Public consultation before end 2010 Watch for further details 14 October 2010 Slide 3

4 Revision of Chapter 7 EU GMP (2) Purpose of the Revision Reflect the range & extent of modern contracting operations Reflect the increased complexity in modern contracted arrangements Harmonisation with ICH Q10 More prescriptive requirements for outsourced operations Particular emphasis on the contract giver s obligations 14 October 2010 Slide 4

5 ICH Q10 ICH Guidelines can be accessed through the following link: ICH Q10 Pharmaceutical Quality System Guidance on key elements for an effective quality system Complements ICH Q8 Pharmaceutical Development & ICH Q9 Quality Risk Management ICH Q10 (Section 2.7): Management of Outsourced Activities & Purchased Materials 14 October 2010 Slide 5

6 Comparison of ICH & EU GMP Requirements ICH Q10 EU GMP Chapter 7 Applies to all outsourced activities & purchased materials Obligations specific to the Contract Giver Assessment should incorporate QRM principles Specific in the need for prior assessment & audit Requires both responsibilities & communication processes to be defined in contract Specific in the need for periodic review of contract acceptor Applies only to contract manufacture and analysis Includes obligations for the contract giver & contract acceptor Not specific to use of QRM Not specific to the need for prior assessment or audit Requires responsibilities to be defined in contract Not specific in terms of requirement for periodic review 14 October 2010 Slide 6

7 Main Principles of ICH Q10 Prior Assessment of the contract acceptor Definition of responsibilities & communication methods Ingredient & material monitoring Monitoring & Review measures 14 October 2010 Slide 7

8 Impact Assessment of Revision to Chapter 7 Additional regulatory burden should be light Technical arrangements for outsourced GMP activities more transparent Clearer & more consistent assessment of outsourced activities Set clearer standards & expectations for industry Harmonised regulatory policy 14 October 2010 Slide 8

9 Implications of Revision to Chapter 7 Extends the range of contracted activities to which Chapter 7 applies Examples of Activities to consider Qualification & Validation Activities QP & Other Professional Services Maintenance & Calibration of Equipment & Premises Storage & archiving 14 October 2010 Slide 9

10 Implications of Revision to Chapter 7 Inclusion of requirements for control over subcontracted operations Mutual Agreement Assessment & On-going Review Contract Giver Prior Assessment Legality Suitability Competence Contract Acceptor On-going Review Records Results Subcontractor Subcontractor 14 October 2010 Slide 10

11 Implications of Revision to Chapter 7 Inclusion of New Requirements for the Contract Communication Processes Subcontracted activities Audit requirement as opposed to visit 14 October 2010 Slide 11

12 Next Steps Review updates Public Consultation before end 2010 GAP Analysis Prepare Strategy Implement Change Points to Consider:- Outsourced Activities not covered under the vendor approval system Review of subcontracting arrangements Review of contracts Points to Consider:- Outsourced Activities not covered under the vendor approval system Review of subcontracting arrangements Prior assessment & Audit obligations Contracts Points to Consider:- Use of change control to implement the strategy 14 October 2010 Slide 12

13 In Summary Current vs. Proposed Contract Manufacture & Analysis Contract Acceptor Outsourced Activities Contract Acceptor & subcontractors Visit Audit 14 October 2010 Slide 13