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

International Pharmaceutical Supplier GMP’s – An Update February 7 th 2006. ISO 15378 : 2005 with PS 9000. ISO 15378. The Next Step. Pharmaceutical Packaging Materials History. ISO 15378 - International 2006. PS 9004 - UK Industry 2004. PS 9000 - UK Industry 2000.

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

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

  2. ISO 15378 : 2005 with PS 9000

  3. ISO 15378 The Next Step

  4. Pharmaceutical Packaging Materials History ISO 15378 - International 2006 PS 9004 - UK Industry 2004 PS 9000 - 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

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

  6. ISO 15378 & PS 9000 Comparison

  7. ISO 15378 & PS 9000 Comparison

  8. ISO 15378 & PS 9000 Comparison Print Requirements

  9. ISO 15378 & PS 9000 Comparison

  10. ISO 15378 & PS 9000 ComparisonRequirements

  11. ISO 15378 & PS 9000 Comparison Focus

  12. ISO 15378 & PS 9000 Comparison Definitions

  13. ISO 15378 & PS 9000 Comparison References

  14. ISO 15378 & PS 9000 ComparisonMarket Focus

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

  16. ISO 15378 & PS 9000 Comparison Ease of Use

  17. ISO 15378 & PS 9000 ComparisonConclusion ISO 15378 : 2006 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

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