#iso15378documents

ISO 15378 defines the quality management system criteria for primary packaging manufacturers in the pharmaceutical and medical device industries, as well as their capacity to consistently supply safe and dependable packaging. Aluminum, containers/components, films, foils, glass, laminate containers, plastics, and rubber are among the packaging materials that come into direct contact with pharmaceutical items. Suppliers of pharmaceutical primary packaging must demonstrate the quality of their manufacturing process by implementing a quality management system (QMS) and good manufacturing practices (GMP).

ISO 15378 specifies quality management system requirements for manufacturers of pharmaceutical and medical device primary packaging materials. The organizations must demonstrate their ability to meet customer requirements consistently basis, including regulatory requirements and international standards applicable to primary packaging materials for such pharmaceutical products. The standard defines GMP principles and QMS requirements for primary packaging materials for pharmaceutical products.