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European and International Certification for Pharmaceutical Packaging Materials

European and International Certification for Pharmaceutical Packaging Materials. The development of an International Standard for Pharmaceutical Packaging Materials Tony Harper Principal UK Expert to ISO/TC 76 WG 6. European and International Standards. UK France Germany Sweden ISO.

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European and International Certification for Pharmaceutical Packaging Materials

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  1. European and International Certification for Pharmaceutical Packaging Materials The development of an International Standard for Pharmaceutical Packaging Materials Tony Harper Principal UK Expert to ISO/TC 76 WG 6 © 2006

  2. European and International Standards • UK • France • Germany • Sweden • ISO © 2006

  3. European Certification • Certipharm – France • QAPP (Quality Association for Pharmaceutical Packaging) – Germany • PQG (Pharmaceutical Quality Group) – UK • Sweden • International Certification Bodies • AJA, BSI, BVQI, DNV, LRQA, NQA, NSAI, SGS-Y, TUV & more to come? © 2006

  4. European Certification • Standards • Auditors • Training • Certification • Co-operation • Recognition • Harmonisation. © 2006

  5. European Certification • France, Germany and UK • Meetings • Comparison of standards • Comparison of auditing • Witnessed audits, two in each country planned • Evaluation • Process for recognition to be defined and then work towards harmonisation of standards, auditor training, auditing and certification • Other interested parties & countries welcome! • Please volunteer – particularly to work on ISO 15378!! © 2006

  6. Auditor Certification • Standards in Europe are similar • Standard of auditing varies • Need to harmonise • Use PQG Auditor Scheme as a basis? • Extend to Europe?? • Extend Worldwide??? © 2006

  7. UK Standards • Codes of Practice – 1990 - 2001 • P00020 Raw Materials • P00021 Printed Components • P00022 Contact Packaging • PS 9000:2001 - >>>>> • Contact & Packaging in one Standard • PS 9004:2004 • Guide to the GMP requirements of PS 9000. © 2006

  8. French Standards • Certipharm • GMP requirements for suppliers • Reading Guide • French translation of PS 9000! © 2006

  9. German Standards • Quality Association Pharmaceutical Packaging – QAPP • Membership of QAPP mandatory for Certification • Secondary Packaging Material Suppliers only • QAPP GMP Standard • Good level of validation. © 2006

  10. Sweden • PS 9000 • Translated into Swedish • Cerbo – Primary (Trollhattan) & Secondary Packaging Materials (Gothenburg) • Nord-Emballage & Zata – Secondary Packaging Materials only (2 sites in Ystad). © 2006

  11. International Standards • ISO 15378:2006 • Includes all of ISO 9001:2000 • Additional requirements for packaging materials • 2006 version – primary packaging only • Mandatory Annex for Printed Components • Guidance Annexes for Risk management and Validation. © 2006

  12. Development process • Initial German ‘ad-hoc’ meeting, 2002 • Ad-hoc group within ISO/TC 76, 2003 • Initial drafts, limited circulation, 2003-4 • UK involvement, suggested significant changes, 2003-2005 • Ad-hoc group became ISO/TC 76 WG 6 • NWI – ISO New Work Item: ISO 15378. © 2006

  13. ISO/TC 76 • “Infusion, transfusion and medical equipment”! • Not the ideal ‘home’ • Limited contacts (internationally) • Drafts did not reach the people who could comment • Input limited to the ‘few’ • Composition of WG 6 was unbalanced. © 2006

  14. UK Input • UK Team • Tony Harper • Roy Evans • Jill Jenkins • Steve Taylor • Ashok Chand • David Abraham • Antoinette Devine • Bill Hewlett • Mike Shorten • John Turner ….. and others - maybe some of you! © 2006

  15. What did UK do! • Ensured a more consistent approach • Removed many errors • Identified omissions • Made significant additions based on PS 9000 • Turned the draft into an auditable document • Assisted the Secretariat with editing. © 2006

  16. The result! © 2006

  17. © 2006

  18. © 2006

  19. ISO 15378 – Key Requirements • 4.2.4 Records • 5.5.3 Internal communication • 6.2.2.1 GMP Training • 6.4 Work environment • 6.5 Maintenance • 7.2.3 Customer communication • 7.4.1 Purchasing • 7.5 Cleanliness & contamination control • 8.2.4.1 OOS (Out of Specification) • 8.3 Non-conforming product. © 2006

  20. The (2) key annexes • Annex B – Validation • Annex C – Risk Management • These two annexes although ‘Normative’, i.e. guidance, are probably the most significant additions to PS 9000 and were developed by an International team. © 2006

  21. ISO 15378:2006 • Publication expected 31/03/06 • Certification will follow • Glass companies expected to lead the way – Internationally • ‘Others’ will follow • What will PQG do to promote and encourage? © 2006

  22. What next? • Extend the scope for Secondary Packaging Materials • Produce a supporting Guidance document • And how do these fit in? >>>>>>>>>>> © 2006

  23. ISO 9001 Scope GMP (GxP) Principles Detail & Auditor competence ISO 9001 + GMP = ISO 15378 GMP Guidance

  24. ISO 9000 E x c i p i e n t s Q7a A P I s I S O 1 5 3 7 8 IPAC-RS G M P PS 9000 Primary Packaging materials Inhalation

  25. Any questions please? TonyHarper@aol.com © 2006

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