ISO 15378:2017 Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) specifies requirements for a QMS when an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, with the goal of enhancing customer satisfaction through effective systems, continuous improvement, and commitment to customer and applicable statutory and regulatory requirements. It is applicable to any organization, regardless of its type or size, or the products and services it provides.
ISO 15378:2017’s GMP principles in production and control of primary packaging materials are important for the safety of a patient receiving the medicinal product because of the direct contact between the packaging materials and the product.
ISO 15378:2017 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products.
ISO 15378:2017 provides two very useful normative annexes:
• Annex C (normative) GMP requirements for printed primary packaging materials
• Annex D (informative) Guidance on verification, qualification, and validation requirements for primary packaging materials