ISO 15378 is a standard designed for manufacturers of primary packaging materials (e.g., glass, plastic, rubber, aluminum) that come into direct contact with medicinal products. It combines the comprehensive quality management requirements of with the stringent principles of Good Manufacturing Practice (GMP) .
is defined as packaging that comes into direct contact with the medicinal product. This includes materials made from glass, rubber, plastic, aluminium, foils, laminates, and various containers and components. As a result, manufacturers of these materials are the primary users of ISO 15378, though the requirements are generic and applicable to any organization regardless of its type, size, or the products and services it provides.
To effectively implement or audit an ISO 15378 system, organizations must focus on several core pillars. These pillars form the framework for a compliant quality management system. iso 15378 key pointspdf free
In the pharmaceutical and medical device industries, patient safety is paramount. The packaging that holds a medication, known as (glass vials, plastic bottles, blister packs, rubber stoppers), must meet exceptionally high standards to ensure the product remains safe, effective, and unadulterated.
Demanding top management commitment, establishing a clear quality policy, and assigning roles and responsibilities. ISO 15378 is a standard designed for manufacturers
ISO 15378 is an international standard that specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products. These materials must consistently meet customer requirements, as well as regulatory and international standards applicable to primary packaging materials.
Production must occur in clean rooms or controlled environments (ISO Class 7 or 8, typically) to minimize particle and microbial contamination. This includes materials made from glass, rubber, plastic,
For companies seeking certification or upgrading their QMS, understanding these key areas is essential:
ISO 15378:2017 integrates ISO 9001 quality management principles with specific Good Manufacturing Practices (GMP) for primary packaging materials of medicinal products. Key requirements include risk management, traceability, controlled environments, and validated processes to ensure safety and compliance. Read a detailed guide at CertBetter .
Understanding internal and external factors, legal frameworks, and the needs of interested parties (pharmaceutical companies and patients).