Role of NRA in Promoting GMP-compliant Blood Management Practices - The Chinese Taipei Experience-

Transcription

1 3rd APEC Blood Supply Chain Policy Forum Role of NRA in Promoting GMP-compliant Blood Management Practices - The Chinese Taipei Experience- Ying-Hua (Ellen), Chen Section Chief / GMP Inspector GMP Inspectorate 9 Dec 衛生福利部食品藥物管理署 Food and Drug Administration, Ministry of Health and Welfare

2 Outline National Blood System Policy, Legislation, coordination strategies & program Structure Centralized Blood Service System Inspection on Blood Establishments Promoting GMP-compliant Moving Forward Conclusion 2016/12/9 2

3 National Blood System Policy To ensure the safety, quality, accessibility and timely availability of blood and blood products to meet patients needs. Legislation Blood & Plasma Derivatives Act (2005) Medical Care Act, Pharmaceutical Affairs Act, and etc. Coordinated Blood strategies and Program Ensure effective operation of voluntary non-remunerated donations system. Ensure the safety and quality of blood and blood products. Promote self-sufficiency in blood and blood Products. 2016/12/9 3

4 Structure of National Blood System to be organized and coordinated at national level (MoHW) Ministry of Health and Welfare (MoHW) Nation Blood Policy Advisory Committee Representative from DoMA, CDC, FDA, NHIA & Ministry of economic Affair; Experts from Taiwan Society of Blood Transfusion, Medical Doctors, Professional etc. Taiwan Blood Services Foundation (TBSF) Chaired by Vice Minister of MoHW Executive Secretary: Taiwan FDA Face to face meeting: twice a year 2016/12/9 4

5 Centralized Blood Service System TBSF is regulated as health & medical care institution meet the requirements of Standards for Blood Establishments Blood centers (incl. Blood stations, Labs, Collection sites) are inspected against PIC/S GMP Guide & national regulations, and authorized by MoHW Reference: 2016/12/9 5

6 Outline National Blood System Inspection on Blood Establishments Objectives & Scope Competent Authority Quality Standards Inspection Procedures Promoting GMP-compliant Moving Forward Conclusion 2016/12/9 6

7 Inspection on Blood Establishments Objectives & Scope To prevent the transmission of infectious disease; To ensure the safety and Quality of blood, Blood components & PdMPs. Whole Blood patients Blood centers, stations Blood collection TBSF Donation Blood Components Storage, Distribution Plasma derived medicinal products (PdMPs) Collection sites (incl. Mobile units) Testing, Processing Plasma (recovered/source) Plasma Fractionator 2016/12/9 7

8 Inspection on Blood Establishments Competent Authority MoHW Nation Blood Policy Advisory Committee 2016/12/9 8

9 GMP Inspectorate MoHW Taiwan FDA Division of Risk Management GMP/GTP/GDP/GLP Inspectorate Pharmaceutical GMP Inspection and Licensing System has been established based on: PIC/S Recommendations(PI 002-3) ICH Q10, ICH Q9 ISO 9001:2008, ISO 19011:2002, ISO17020:1998 Competent inspectors Qualification & training Quality manual, SOPs, work instructions 2016/12/9 9

10 A member of PIC/S Taiwan FDA was accepted by PIC/S Committee as the 43th (6th in Asia) PIC/S Participating Authority starting on Jan. 1, 2013 Training opportunity Rapid Alert System International GMP harmonization Information sharing Networking 2016/12/9 10

11 Inspection on Blood Establishments Quality standards International GMP standards - PIC/S GMP Guide 2016/12/9 11

12 ASEAN MRA on GMP inspection 2016/12/9 12

13 Adopted PIC/S GMP since 2006 Bilingual version of GMP Guide 2016/12/9 13

14 Structure of PIC/S GMP Guide Part I Basic Requirements for Medicinal Products principles and general requirements for the manufacture of medicinal products Annexes provide detail on specific areas of activity. For some manufacturing processes, different annexes will apply simultaneously Part II Basic Requirements for APIs principles and general requirements for the manufacture of active substances used as starting materials 2016/12/9 14

15 Part I of PIC/S GMP Guide QUALITY MANAGEMENT CONTRACT MANUFACTURE AND ANALYSIS;SELF INSPECTION Input Process output MATERIALS PREMISES & EQUIPMENT PERSONNEL PRODUCTION SM FP Validation, Prevention of cross-contamination, MIX-UP Release COMPLAINTS PRODUCT RECALL DOCUMENTATION QUALITY CONTROL 2016/12/9 15

16 Annexes of PIC/S GMP Guide Annex 1 Manufacture of Sterile Medicinal Products Annex 2 Manufacture of Biological Active Substances and Medicinal Products Annex 3 Manufacture of Radiopharmaceuticals Annex 4 Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products Annex 5 Manufacture of Immunological Veterinary Medicinal Products Annex 6 Manufacture of Medicinal Gases Annex 7 Manufacture of Herbal Medicinal Products Annex 8 Sampling of Starting and Packaging Materials Annex 9 Manufacture of Liquids, 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 17 Parametric Release Annex 19 Reference and Retention Samples 2016/12/9 16

17 2016/12/9 17

18 other Guidance 2016/12/9 18

19 1. DOCUMENT HISTORY 2. INTRODUCTION 3. PURPOSE 4. SCOPE 2016/12/9 5. QUALITY MANAGEMENT 6. PERSONNEL 7. PREMISES 8. EQUIPMENT 9. DOCUMENTATION 10.DONOR SESSIONS 11.COMPONENT PREPARATION 12.STORAGE AND DISPATCH 13.QUALITY MONNITORING 14.LABORATORY TESTING 15.COMPLAINS AND RECALL 16. REFERENCES 17. RELEVANT TERMINOLOGY 18. REVISION HISTORY 19

20 Inspection on Blood Establishments Inspection Procedures Be routinely inspected every 3 years (2011, 2014, 2017) Unannounced inspections may be performed, if necessary Inspection team GMP inspectors of Taiwan FDA External experts (Medical Doctors & Medical Technologist) in the filed Blood transfusion, Hematology, Blood banks operation, Laboratory of biochemistry, Medical Laboratory Science and Biochemistry Pre-inspection A master file of BE and related documents are submited. Pre-inspection meetings with inspection team To discuss the scope (blood Center, stations, collection sites, mobile units), focus and depth of inspection To prepare the inspection plan (including the inspection agenda and aide-memoir ) Notification of the inspection to BEs 2016/12/9 20

21 Inspection on Blood Establishments Inspection procedures Conduct inspection Takes an average of 3-4 days Typically conducted by 3-4 inspectors & 4 external experts Issue Exit Notice (list of observations) Post-inspection GMP inspection report will be issued to the BEs BEs need to submit CAPAs Inspection team assess the CAPAs Re-inspection may be performed, if necessary Close the inspection/ Extend the manufacturing license Notify any substantial change to Taiwan FDA for approval Depended on the change, approval by dossier verification or on-site inspection. In 2016, four on-site inspection were conducted 2016/12/9 21

22 Outline National Blood System Inspection on Blood Establishments Promoting GMP-compliant Leverage the international resources Training for inspectors & industry Work together with Blood Establishments Moving Forward Conclusion 2016/12/9 22

23 Promoting GMP-compliant Leverage the International Resources PIC/S Expert Circle Work together with Blood Establishments TBSF Training for Inspectors Training for Industry

24 Promoting GMP-compliant Leverage the International Resources Pharmaceutical Inspection Co-operation Scheme (PIC/S) An informal co-operative arrangement between Regulatory Authorities in the field of GMP of medicinal products To lead the international development, implementation and maintenance of harmonized GMP standards and Quality Systems of inspectorates in the field of medicinal products Providing training opportunities to inspectors. Facilitating co-operation and networking between competent authorities, regional and international organizations, thus increasing mutual confidence. Partners: EDQM, EMA, UNICEF, WHO 2016/12/9 24

25 PIC/S comprised 49 Participating Authorities from all continents Applicants (5) : Brazil / ANVISA Iran / IFDA Mexico / COFEPRIS Philippines / PFDA Turkey / TMMDA Pre-Applicants (3) Belarus / MoH Chile / ISP Kazakhstan / CCMPA EU Member States (27), Europe: Switzerland, Norway, Iceland, Liechtenstein, Ukraine America: Canada, USA, Argentina Asia: Singapore, Malaysia, Israel, Indonesia, Chinese Taipei, Korea, Japan, HK, Thailand Oceania: Australia, New Zealand Africa: South Africa 2016/12/9 25

26 PIC/S Expert Circles To enable Inspectors to discuss and exchange information on specific technical areas of GMP; To develop draft guidance documents & jointly revise the EU/PICS GMP Guide; To provide for training opportunities in their field of expertise Currently active EC Active Pharmaceutical Ingredients, Human Blood, Tissues, Cells & ATMPs Computerized Systems, Good Distribution Practice, Quality Risk Management only open to inspectors from PIC/S members, (Pre-)Applicants, Partners and Non-Member NRA. Nor open to Industry. 2016/12/9 26

27 PIC/S EC on Human Blood, Tissues, Cells & ATMPs Mandate of the EC (valid 2 years after adopted on July 2016) To hold experts' discussions and training of Inspectors in the field of blood, blood components, plasma derivatives, cells and tissues with particular focus on ATMPs; To finalize guidelines and aide memoires developed by the previous EC and develop guidelines and aide memoires on new topics such as ATMPs; PIC/S GMP guidance for blood establishments (PE-005-3) to be revised and harmonized with EU Good Practices Guidelines for blood establishments, and EUBIS inspection guide to be used as a source for new items in the revision To map competences of PIC/S members with particular focus on the inspection of products manufactured in the field human blood, tissues and cells (including ATMPs). 2016/12/9 27

28 PIC/S EC meeting 2016 in HK 2015 in Rome 2013 in Taipei Program: Presentations, Workshops, Blood Establishments tour 2016/12/9 28

29 Promoting GMP-compliant Training for Inspectors Training activities from PIC/S International Seminars/conferences Observations of inspections In-house study groups 2016 IPFA Asia Pacific Workshop in Taipei - Plasma Quality and Supply 2016/12/9 29

30 Promoting GMP-compliant Training for Industry TFDA organizes GMP seminar/workshops free open to pharmaceutical industry (incl. Blood Establishments) every year Budgets from Taiwan FDA; Co-organized with associations (PDA-TW chapter, TPQRI ) 2016/12/9 30

31 Promoting GMP-compliant Work together with BEs Knowledge flows between inspectors and operators in BEs during inspection TBSF

32 Outline National Blood System Inspection on Blood Establishments Promoting GMP-compliant Moving Forward Conclusion 2016/12/9 32

33 Moving Forward Keep updating and harmonizing the regulation system & quality standards internationally Actively participating the PIC/S Expert Circle on Human Blood, Tissues, Cells & ATMPs Join the WG on revision of PIC/S GMP guidance for blood establishments (PE-005-3) Continual training on competent inspectors trained in specificity of the blood processing Training both theoretical and on site (mock inspection by experienced inspector, PIC/S training) Keep promoting GMP-compliant of BEs 2016/12/9 33

34 Revision of PIC/S GMP guidance for blood establishments (PE-005-3) To be continued after the meeting in HK this October A working group is going to be formed to further review and complete the Guide. Several attendees volunteered to participate to a drafting group To be harmonized with EU Good Practices Guidelines for blood establishments, and EUBIS inspection guide to be used as a source for new items in the revision An advanced revised draft to be presented and discussed during the next EC meeting 2016/12/9 34

35 Outline National Blood System Inspection on Blood Establishments Promoting GMP-compliant Moving Forward Conclusion 2016/12/9 35

36 Conclusion The Quality Journey is a Voyage, NOT a Destination! We re Committed to our Quality Journey Better Together! Consumer Protection Win-Win Government Smart Administration Blood Establishments Competences 2016/12/9 36

37 Thank You for Your Attention Chiang Kai-shek Memorial Hall Taipei 101 Yehliu Geopark Sun Moon Lake North-East coast of Taiwan Pingxi Flying Lanterns Penghu Night Markets Temples For more information: Website is at /12/9 37