Standard Swedish standard · SS-EN 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) (ISO 15378:2015)

Status: Withdrawn

· Replaced by: SS-EN ISO 15378:2017
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.

In this International Standard, the term “if appropriate” is used several times. When a requirement is qualified by this phrase, it is deemed to be “appropriate” unless the organization can document a justification otherwise.


Management systems (03.100.70) General (11.040.01)

Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-8017189

Edition: 3

Approved: 11/9/2015

No of pages: 84

Replaces: SS-EN ISO 15378:2011

Replaced by: SS-EN ISO 15378:2017