International Pharmaceutical Supplier GMP’s – An Update

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Presentation transcript:

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

ISO 15378 : 2005 with PS 9000

The Next Step ISO 15378

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

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

ISO 15378 & PS 9000 Comparison

ISO 15378 & PS 9000 Comparison

ISO 15378 & PS 9000 Comparison Print Requirements

ISO 15378 & PS 9000 Comparison

ISO 15378 & PS 9000 Comparison Requirements

ISO 15378 & PS 9000 Comparison Focus

ISO 15378 & PS 9000 Comparison Definitions

ISO 15378 & PS 9000 Comparison References

ISO 15378 & PS 9000 Comparison Market Focus

ISO 15378 & PS 9000 Comparison Why / How Guidance

ISO 15378 & PS 9000 Comparison Ease of Use

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