What is ISO 15378 - Primary packaging materials for medicinal products about?
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:
- Needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements
- 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.
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.
Who is ISO 15378 - Primary packaging materials for medicinal products for?
ISO 15378 on packaging materials for medicinal products with the requirement of good manufacturing practice is useful for:
- A manufacturing unit of the pharmaceuticals sector
- Product managers
- Professional workers who involved in the packaging department
Why should you use ISO 15378 - Primary packaging materials for medicinal products?
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.
What’s changed since the last update?
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:
- The integration of the sector-specific requirements on quality management systems for medicinal products into ISO 9001:2015
- The deletion of the requirements on quality manual
- The inclusion of all annexes of ISO 9001:2015 into ISO 15378:2017
- Adjustments to the terminology of ISO 9000:2015, where relevant
- The inclusion of an alphabetical index of defined terms used in ISO 15378:2017