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ISO 15378 - Primary packaging materials for medicinal products |
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Tuesday, 17 November 2009 12:24 |
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The International Organization for Standardization issued the standard ISO 15378 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) in order to improve patient safety and to promote implementation of good Manufacturing Practices for pharmaceutical companies.
The model concerns the pharmaceutical companies which produce packaging materials and determines good manufacturing practices for the design, manufacture and distribution of these materials. The model incorporates the requirements for quality management and structure of ISO 9001 and includes additional annexes as follows:
- Specifications for the conformity of the medicine packaging
- Directive on the verification and validation of drug packaging materials
- Directive on risk management (risk management)
PRIORITY has the necessary expertise to develop a system based on the requirements of the standard.
In addition, PRIORITY supports the customer after certification by conducting internal audits and providing consulting services.
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