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

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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 - PowerPoint PPT Presentation

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Medsafe GMP update / release for supply / communicating quality issuesDerek FitzgeraldManager, Compliance Management11 July 2013

RACI Pharmaceutical Science Group (NSW)

Medsafe and GMP Medsafe an introduction GMP update Release for supply New Zealand Communicating quality issues

2MedsafeThe New Zealand Medicines and Medical Devices Safety AuthorityRelevant legislation Medicines Act 1981, Medicines Regulations 1984Comprises several BranchesCompliance ManagementProduct RegulationClinical Risk Management3CMB area of operationGMP audit and licensing / certificationMedicines and medical devices complaints & recallsInvestigations and prosecutionsMedicines testing programmeMedical devices listing database (WAND)Advertising complaints and issuesAdvice on legislation and policyLegislative complianceBorder control

4CMB TeamsProduct Safety (Wellington) (8 staff)Post-market complaints, recalls & market actionsGMPMedicines testing programmeMedical devices WANDAdvertising issuesSupply of unapproved productsInvestigations & Enforcement Team (Auckland) (5 staff)Investigations and prosecutionsBorder control and importation5Some post-market statisticsFor the full financial year: Jul 2012 Jun 2013Medicines incidents handled / closed: 478, of which 29 were recallsMedical devices incidents handled / closed: 1,067, of which 284 were recalls or market actionsGMP audits conducted: 49Packages inspected at the border: 11,5006The New Zealand GMP SceneCurrently around 50 active sites Wide range of manufacturing operations8 API including clinical trials, biologicals10 complementary medicines8 blood service or similar5 gas sites2 overseas4 testing laboratories10 packing sites

7GMP operationsMedsafe performs around 50 audits annually with 3 auditors (recent increase)Audit frequency is determined through risk assessment performed at each auditVarious mechanisms used to ensure resolution of GMP issues is achievedOngoing interaction and follow up is commonGrowing requirement for advice on post-market issues

8GMP developments Now a PIC/s member ANZTPA B2B B4 Information sharingJoint trainingJoint auditsFuture alignment of processes Closer relationship with TGA Application to EU in respect of API third country exemption status

9ANZTPAIntention 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 processCurrently NZ and Australia are closely aligned with respect to Good Manufacturing Practice

10Trans-Tasman GMP relationshipOver 2 decades of cooperationClose GMP alignment Strong relationship build up to ANZTPA #1 Being a competent and credible small GMP regulator requires close relationships and cooperation with othersLooking forward to a continuing and growing relationship11Release for supply in NZ - overview Legislative requirements Licensing of sponsors Issues noted GMP / contractual arrangements Process

12Legislative 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)

13Licensing of sponsors Licence to Sell Medicines by Wholesale Audits carried out by Ministry of Health Monitoring of compliance through interactions during quality investigations / recalls

14Issues notedStock imported and distributed when not for the NZ marketFailure to meet current approved specificationsOff-shore actions creating liability in NZFailure to understand responsibilityNeed to fully understand products, GMP / technical issues and legal issues

15Contractual arrangements Distribution chain can be complex Need to ensure technical arrangements are met and responsibility clear Flexible several models of operation accepted

16Process summaryA licensed NZ entity responsible for market releaseNZ approved product details are heldStock is received into quarantineC of A is received and compared with approved detailsBatch is identified and labelling is examinedRelease can be made

17Communicating 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

18Responding to quality issues - when the regulator has questionsEnsuring a clear line of communication between manufacturing site / NZ sponsor / MedsafeThe NZ sponsor is legally responsibleRapid response is required even if full answers may take timeRisk assessment based on product knowledge importantEffective action in the distribution chain19Responding 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? 20Regulatory expectationsMedsafe has the expertise to understand your explanationWe are looking for you to demonstrate competence in handling issuesWe look at what you send and assess itImportant to be consistentBe honestEnsure all questions are answered21A good technical responseThere should be a clear description of the problem Describe the investigation so farEnsure clinical assessment is provided, if appropriateDistribution details are importantIdentify the possible manufacturing issuesBe clear about testing performed / plannedProvide rationale for possible explanations and for ruling out possibilities22Thank youContact details:Medsafe website: www.medsafe.govt.nzEmail contacts for specific questionsGMP: askmedsafe@moh.govt.nzProduct Safety Team: recalls@moh.govt.nz23