Standard Swedish standard · SS-EN ISO 15378:2007

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2006)

Status: Withdrawn

· Replaced by: SS-EN ISO 15378:2011

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Standard Swedish standard · SS-EN ISO 15378:2007

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Scope

This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.

Subjects

Quality management and quality assurance (03.120.10) General (11.040.01)

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Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2006)

Subjects

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