ISO 15378:2011 - Primary packaging materials for medicinal products




Its a Quality Management System for Medicinal Packaging Materials Suppliers for 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 15378:2011 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.

ISO 15378:2011 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.

Benefits of being certified to ISO 15378 ?
  • Save money and time: with a service provider that eliminates the need for multiple assessments and improves productivity through process optimization.
  • Minimize risk: by achieving documented compliance with safety standards, thereby avoiding costly liability.
  • Gain a competitive edge: by demonstrating the ISO 15378 compliance of your organization to all stakeholders with a trusted third-party certification partners.