DS EN ISO 15378 : 2017
Current
The latest, up-to-date edition.
PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) (ISO 15378:2017)
12-01-2013
Defines Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials 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.
| Committee |
DS/S-216
|
| DevelopmentNote |
2015 Edition is still active and will be withdrawn on 30/04/2018. (11/2017) New child AMD 1 2024 is now added
|
| DocumentType |
Standard
|
| ProductNote |
New child AMD 1 2024 is now added
|
| PublisherName |
Danish Standards
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 15378:2017 | Identical |
| ISO 15378:2017 | Identical |
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