ISO 15378:2011 PDF Download
Standard EN Sample
Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
Also Known As:
SKU915718267
Published by
International Organization for Standardization
ISO
Publication Date2011-11
Pages CountPages78
ISO 15378:2011 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.
ISO 15378:2011 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.
Details
History and complementary documents
History
| Edition | 2 |
| ICS Codes | 03.100.70 - Management systems 11.040.01 - Medical equipment in general |
| Language(s) | English |
| File Size | 849.9 KB |
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