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Medsafe – GMP update / release for supply / communicating quality issues. Derek Fitzgerald Manager, Compliance Management. 11 July 2013 RACI Pharmaceutical Science Group (NSW). Medsafe and GMP. Medsafe – an introduction GMP update Release for supply – New Zealand

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Medsafe – GMP update / release for supply / communicating quality issues


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    1. Medsafe – GMP update / release for supply / communicating quality issues Derek Fitzgerald Manager, Compliance Management 11 July 2013 RACI Pharmaceutical Science Group (NSW)

    2. Medsafe and GMP • Medsafe – an introduction • GMP update • Release for supply – New Zealand • Communicating quality issues

    3. Medsafe • The New Zealand Medicines and Medical Devices Safety Authority • Relevant legislation – Medicines Act 1981, Medicines Regulations 1984 • Comprises several ‘Branches’ • Compliance Management • Product Regulation • Clinical Risk Management 3

    4. CMB – area of operation • GMP audit and licensing / certification • Medicines and medical devices complaints & recalls • Investigations and prosecutions • Medicines testing programme • Medical devices listing database (WAND) • Advertising complaints and issues • Advice on legislation and policy • Legislative compliance • Border control 4

    5. CMB Teams • Product Safety (Wellington) (8 staff) • Post-market complaints, recalls & market actions • GMP • Medicines testing programme • Medical devices – WAND • Advertising issues • Supply of unapproved products • Investigations & Enforcement Team (Auckland) (5 staff) • Investigations and prosecutions • Border control and importation 5

    6. Some post-market statistics For the full financial year: Jul 2012 – Jun 2013 • Medicines incidents handled / closed: 478, of which 29 were recalls • Medical devices incidents handled / closed: 1,067, of which 284 were recalls or market actions • GMP audits conducted: 49 • Packages inspected at the border: 11,500 6

    7. The New Zealand GMP Scene • Currently around 50 ‘active’ sites • Wide range of manufacturing operations • 8 API – including clinical trials, biologicals • 10 complementary medicines • 8 blood service or similar • 5 gas sites • 2 overseas • 4 testing laboratories • 10 packing sites 7

    8. GMP operations • Medsafe performs around 50 audits annually with 3 auditors (recent increase) • Audit frequency is determined through risk assessment performed at each audit • Various mechanisms used to ensure resolution of GMP issues is achieved • Ongoing interaction and follow up is common • Growing requirement for advice on post-market issues 8

    9. GMP developments • Now a PIC/s member • ANZTPA B2B – B4 • Information sharing • Joint training • Joint audits • Future alignment of processes • Closer relationship with TGA • Application to EU in respect of API third country exemption status 9

    10. ANZTPA • Intention of both Governments to proceed with the establishment of a joint agency • Key points – Joint Agency, new / updated legislation (especially for New Zealand) • Work is underway on planning the establishment process • Currently NZ and Australia are closely aligned with respect to Good Manufacturing Practice 10

    11. Trans-Tasman GMP relationship • Over 2 decades of cooperation • Close GMP alignment • Strong relationship build up to ANZTPA #1 • Being a competent and credible small GMP regulator requires close relationships and cooperation with others • Looking forward to a continuing and growing relationship 11

    12. Release for supply in NZ - overview • Legislative requirements • Licensing of ‘sponsors’ • Issues noted • GMP / contractual arrangements • Process 12

    13. Legislative requirements • Sale of a medicine • Requirement to be licensed • Section 42 – specifications and testing • Sections 20 and 24 – product approval • Recall and other market actions (regulation 50) 13

    14. Licensing of sponsors • Licence to Sell Medicines by Wholesale • Audits carried out by Ministry of Health • Monitoring of compliance through interactions during quality investigations / recalls 14

    15. Issues noted • Stock imported and distributed when not for the NZ market • Failure to meet current approved specifications • Off-shore actions creating liability in NZ • Failure to understand responsibility • Need to fully understand products, GMP / technical issues and legal issues 15

    16. Contractual arrangements • Distribution chain can be complex • Need to ensure technical arrangements are met and responsibility clear • Flexible – several models of operation accepted 16

    17. Process summary • A licensed NZ entity responsible for market release • NZ approved product details are held • Stock is received into quarantine • C of A is received and compared with approved details • Batch is identified and labelling is examined • Release can be made 17

    18. Communicating quality issues • Responding to the regulator • Responding to a market issue • Dealing with issues successfully • Response is important and determines the level of confidence a regulator can have in a manufacturer / sponsor 18

    19. Responding to quality issues - when the regulator has questions • Ensuring a clear line of communication between manufacturing site / NZ sponsor / Medsafe • The NZ sponsor is legally responsible • Rapid response is required – even if full answers may take time • Risk assessment based on product knowledge – important • Effective action in the distribution chain 19

    20. Responding to market quality issues • How is a quality complaint received? • Who is involved in making early decisions? • Ensure rapid risk assessment • Systems should be integrated – production, marketing, distribution, clinical, QA • How will decisions be made? 20

    21. Regulatory expectations • Medsafe has the expertise to understand your explanation • We are looking for you to demonstrate competence in handling issues • We look at what you send and assess it • Important to be consistent • Be honest • Ensure all questions are answered 21

    22. A good technical response • There should be a clear description of the problem • Describe the investigation so far • Ensure clinical assessment is provided, if appropriate • Distribution details are important • Identify the possible manufacturing issues • Be clear about testing performed / planned • Provide rationale for possible explanations and for ruling out possibilities 22

    23. Thank you • Contact details: • Medsafe website: www.medsafe.govt.nz • Email contacts for specific questions • GMP: askmedsafe@moh.govt.nz • Product Safety Team: recalls@moh.govt.nz 23