ISO 15378-Primary packaging materials for medicinal products
ISO 15378:2015 identify necessities for a quality management system where an organization requirements to demonstrate its capability to give primary packaging materials for medicinal products, which constantly meet client necessities, including regulatory necessities and International Standards applicable to primary packaging materials.
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.
Decrease and control of risks
Presentation of the company’s expertise
Creation of competitive advantages
Time and cost savings
Evidence of compliance with statutory regulations and contractual agreements
Development of the quality ability