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.
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.
Benefits of ISO 15378:2015 Certification
- 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