1. International Pharmaceutical Supplier GMP’s – An Update
February 7th 2006

2. ISO : 2005 with PS 9000

5. The Next Step
ISO 15378

6. Pharmaceutical Packaging Materials History
ISO International 2006
PS UK Industry 2004
PS UK Industry 2000
Code(s) of Practice - UK Industry 1995
Code(s) of Practice - UK Industry 1990
Audits Company
AQL’s Company (BS 6001)
Standards Company
Quality Visits Company
Specifications - Company and National

7. Standards Comparison ISO 15378 : 2006 Versus PS 9000 : 2000
(And PS 9004 : 2004)

8. ISO & PS 9000 Comparison

9. ISO & PS 9000 Comparison

10. ISO 15378 & PS 9000 Comparison Print Requirements

11. ISO & PS 9000 Comparison

12. ISO 15378 & PS 9000 Comparison Requirements

13. ISO 15378 & PS 9000 Comparison Focus

14. ISO 15378 & PS 9000 Comparison Definitions

15. ISO 15378 & PS 9000 Comparison References

16. ISO 15378 & PS 9000 Comparison Market Focus

17. ISO 15378 & PS 9000 Comparison Why / How Guidance

18. ISO 15378 & PS 9000 Comparison Ease of Use

19. ISO 15378 & PS 9000 Comparison Conclusion
The next Quality Step for Pharma Materials
An International Standard
For Primary Materials ONLY
Uses ISO 9001 : 2000 QMS
More Formal / Demanding the PS 9000
More GMP Requirements
Creates Harmony between Suppliers and Customers
But PS 9000 continues for Secondary Materials