November 11, 2015
INTERNATIONAL - The International Organization for Standardization (ISO) has issued revised standard ISO 15378:2015 Primary packaging materials for medicinal products, with particular requirements for the application of ISO 9001:2008, and referencing Good Manufacturing Practice (GMP).
The standard specifies the 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, regulatory requirements and International Standards applicable to primary packaging materials.
The standard was developed under the ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use.
The standard was published as an International standard on October 6, 2015.