ISO 15378:2015

Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)

Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)

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Referenced standards

ASTM E2500-13IEC 60601-1:2005IEC 60812:2006IEC 61025:2006IEC 61882:2001ISO 10007:2003ISO 10012:2003ISO 11135:2014ISO 9000:2005ISO 9001:2008ISO 9001:2015ISO 9004:2009ISO Guide 73:2009ISO/IEC Guide 2:2004ISO/IEC Guide 99:2007
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ISO 15378:2015

Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)

Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)

ISO 15378:2015 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.

Edition2015
Published Date2015
Published ByInternational Standardization Organisation
Page Count63