Overview

ISO 15378:2018 specifies requirements for a quality management system for manufacturers of primary packaging materials for medicinal products. It combines ISO 9001 requirements with Good Manufacturing Practices relevant to pharmaceutical packaging.

This standard is highly relevant for organizations supplying packaging materials that directly affect the safety and quality of medicinal products.

Who Can Apply

• Pharmaceutical packaging material manufacturers
• Caps, closures, and container manufacturers
• Bottle and blister packaging suppliers
• Manufacturers of primary packaging components for medicinal products
• Suppliers serving pharmaceutical packaging chains

Benefits

• Supports GMP-aligned packaging systems
• Improves product quality and process control
• Strengthens traceability and risk management
• Builds confidence with pharmaceutical customers
• Improves documentation and compliance discipline
• Supports market acceptance in regulated sectors

Our Support

We provide ISO 15378 support including manual preparation, SOPs, record formats, risk-based documentation, implementation guidance, training, internal audit support, and certification readiness.

Our support is designed to help packaging manufacturers build practical, controlled, and compliance-focused systems.