PACKAGING FOR MEDICAL PRODUCTS – ISO 15378

ISO 15378 is an international standard that specifies requirements for a quality management system (QMS) for the production of primary packaging materials for medicinal products. This standard, titled “ISO 15378 Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001, with reference to Good Manufacturing Practice (GMP),” outlines specific requirements for packaging materials used in the pharmaceutical and medical industries.

The Standard covers the quality management system requirements for the suppliers of different materials which need to be used in the packaging of medicinal products.

ISO 15378 emphasizes the importance of risk management in the production of primary packaging materials. Organizations are required to identify and manage risks related to product quality and safety with improved product traceability, change control, hygiene and contamination control, process validations and handling and storage.

ISO 15378 is applicable to manufacturers of primary packaging materials, including glass, plastics, rubber, and metal materials used for the packaging of medicinal products. Compliance with this standard helps ensure the quality, safety, and consistency of packaging materials in the pharmaceutical and medical industries.

Organizations seeking ISO 15378 certification undergo an audit process conducted by a certification body to demonstrate their compliance with the standard’s requirements. Certification provides external validation of a company’s commitment to quality and Good Manufacturing Practice in the production of primary packaging materials for medicinal products.