ISO 15378

Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)

International standard specifies requirements for a quality management system, that is used for primary packaging materials for medicinal products. Primary packaging is an important factor at providing quality, efficient and safe medicinal product.

In addition to ISO 9001, this document specifies 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.

ISO 15378:2017 specifies requirements for a quality management system when an organization:

1. needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
2. aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.