ISO 15378 Quality Management System for Medicinal Packaging Materials Suppliers
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 15378:2011 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.
- Your benefits at a glance:
- 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 partner.