International Pharmaceutical Supplier GMP

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• International Pharmaceutical Supplier GMPs An
  Update
• February 7th 2006

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ISO 15378 2005 with PS 9000
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The Next Step
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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
AQLs - Company (BS 6001)
Standards - Company
Quality Visits - Company
Specifications - Company and National
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Standards Comparison

• ISO 15378 2006
• Versus
• PS 9000 2000
• (And PS 9004 2004)

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ISO 15378 PS 9000 Comparison
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ISO 15378 PS 9000 Comparison
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ISO 15378 PS 9000 Comparison Print Requirements
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ISO 15378 PS 9000 Comparison
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ISO 15378 PS 9000 ComparisonRequirements
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ISO 15378 PS 9000 Comparison Focus
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ISO 15378 PS 9000 Comparison Definitions
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ISO 15378 PS 9000 Comparison References
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ISO 15378 PS 9000 ComparisonMarket Focus
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ISO 15378 PS 9000 Comparison Why / How Guidance
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ISO 15378 PS 9000 Comparison Ease of Use
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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