2. 31/01/2006© 20061 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

3. 31/01/2006© 20062 European and International Standards UK France Germany Sweden ISO

4. 31/01/2006© 20063 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?

5. 31/01/2006© 20064 European Certification Standards Auditors Training Certification Co-operation Recognition Harmonisation.

6. 31/01/2006© 20065 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!!

7. 31/01/2006© 20066 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???

8. 31/01/2006© 20067 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.

9. 31/01/2006© 20068 French Standards Certipharm GMP requirements for suppliers Reading Guide French translation of PS 9000!

10. 31/01/2006© 20069 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.

11. 31/01/2006© 200610 Sweden PS 9000 Translated into Swedish Cerbo – Primary (Trollhattan) & Secondary Packaging Materials (Gothenburg) Nord-Emballage & Zata – Secondary Packaging Materials only (2 sites in Ystad).

12. 31/01/2006© 200611 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.

13. 31/01/2006© 200612 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.

14. 31/01/2006© 200613 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.

15. 31/01/2006© 200614 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!

16. 31/01/2006© 200615 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.

17. 31/01/2006© 200616 The result!

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20. 31/01/2006© 200619 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.

21. 31/01/2006© 200620 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.

22. 31/01/2006© 200621 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?

23. 31/01/2006© 200622 What next? Extend the scope for Secondary Packaging Materials Produce a supporting Guidance document And how do these fit in? >>>>>>>>>>>

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

25. Q7a A P I s I S O 1 5 3 7 8 PS9000PS9000 GMPGMP ExcipientsExcipients IPAC-RSIPAC-RS Primary Packaging materials ISO 9000 Inhalation

26. 31/01/2006© 200625 Any questions please? TonyHarper@aol.com