ISO 15378:2017

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ISO 15378:2017 is an international standard that outlines quality management system (QMS) requirements for manufacturers of primary packaging materials for medicinal products. It applies to organizations of all sizes and types

ISO 15378:2017 is an international standard that specifies the requirements for a quality management system (QMS) for organizations involved in the manufacturing of primary packaging materials for medicinal products. This standard is particularly relevant for companies that produce packaging materials intended for direct contact with medicines, such as bottles, vials, caps, blisters, syringes, and other packaging components used in the pharmaceutical industry.