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ISO 15378:2006

Primary Packaging Materials for Medicinal Products, Particular Requirements for the Application of ISO 9001:2000 with Reference to Good Manufacturing Practice (GMP)

Packaging Materials Medicinal ProductsDrug Blister Packs Combining ISO 9001 and Good Manufacturing Practice (GMP), ISO 15378 specifies the requirements for quality system management and the application for the design, manufacture and supply of primary packaging materials for medicinal products.

Pharmaceutical companies and their packaging suppliers can rely on this standard to help:

- Minimize or eliminate instances of contamination, mix-ups, and errors.

- Reassure business partners and customers of commitment to quality

- Protect customers from purchasing potentially ineffective or dangerous products

The introduction of ISO 15378 gives companies in the pharmaceutical sector a more direct path to implement Good Manufacturing Practices and quality management.

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