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)
Media and price
| Language | Format | Add to basket |
|---|---|---|
| English | PDF (2 700 kB) | CHF 158,00 |
| English | Paper | CHF 158,00 |
| French | PDF (3 061 kB) | CHF 158,00 |
| French | Paper | CHF 158,00 |
| Russian | PDF (1 403 kB) | CHF 158,00 |
| Russian | Paper | CHF 158,00 |
General information
Number of Pages: 59
| Edition: 1 (Monolingual) | ICS: 11.040.01; 03.120.10 |
| Status: Published | Stage: 90.92 (2009-07-20) |
| TC/SC: TC 76 |
Abstract
ISO 15378:2006 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 15378:2006 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.
Revision information
Revised by: ISO/DIS 15378
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