Meet quality objectives for your primary packaging materials for medicinal products.
Pharmaceutical and medical device primary packaging materials include glass, rubber, plastics, Aluminium containers/components, Films, Foils and Laminate Containers. As these materials come in direct contact with medicinal products, they need to comply with safety, efficacy and reliability requirements. Suppliers of primary packaging materials have to meet the expectations of medicinal product manufacturers and demonstrate compliance with expected quality levels by integrating quality management systems (QMS) and good manufacturing practice (GMP) in their production processes.
ISO 15378:2017 specifies requirements for a quality management system for manufacturers of pharmaceutical and medical device primary packaging materials. These organizations need to demonstrate their ability to consistently meet customer requirements, including regulatory requirements and international standards applicable to primary packaging materials for such medicinal products. The standard delineates GMP principles and specifies QMS requirements Applicable to primary packaging materials for medicinal products.
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