Client note: In support of the ISO London Declaration on Climate Change, ISO passed a resolution last year that has resulted in two new statements of text being added to a number of existing management systems standards (MSS), and will be included in all new standards under development/revision, to address the need to consider the effect of Climate Change on the ability to achieve the intended results of the management system.
If you previously bought one of the below quality management standards, you will be entitled to receive an updated amendment with the 2024 London Declaration version of the standard:
If you’re eligible for the revised 2024 London Declaration version, we will be in touch as soon as possible. For further information and any questions you may have, please contact cservices@bsigroup.com.
ISO 15378 is an international standard that focuses on primary packaging material for medicinal products. Primary packaging materials for medicinal products provides the specification on packages and the packaging processes for pharmaceuticals preparations. ISO 15378 specifies requirements for a quality management system when an organization:
All the requirements of ISO 15378 are generic and are intended to apply to any organization, regardless of its type or size, or the products and services it provides.
Note 1: In ISO 15378, the terms “product” or “service” only apply to products and services intended for, or required by, a customer.
Note 2: Statutory and regulatory requirements can be expressed as legal requirements.
ISO 15378 on packaging materials for medicinal products with the requirement of good manufacturing practice is useful for:
Primary packaging materials for medicinal products involves all of the operations from production through drug distribution channels to the end consumer. The adoption of an ISO 15378 is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives. ISO 15378 also ensure that the responsibilities and authorities for relevant roles are assigned, communicated, and understood within the organization.
ISO 15378 identifies Good Manufacturing Practice (GMP) principles and specifies requirements for a quality management system applicable to primary packaging materials for medicinal products. The realization of GMP principles in the production and control of primary packaging materials within organizations is of great importance for the safety of a patient using the medicinal product, because of their direct product contact. The application of Good Manufacturing practices for pharmaceutical packaging materials helps ensure that these materials meet the needs and requirements of the pharmaceutical industry. Using ISO 15378 you can specify requirements for a quality management system.
BS EN ISO 15378:2017 supersedes BS EN ISO 15378:2015. BS EN ISO 15378:2017 includes some technical changes concerning BS EN ISO 15378:2015. These include:
ISO 15378:2017/Amd 1:2024
EN ISO 15378:2017/Amd 1