ISO 15378 Primary packaging materials for medicinal products

ISO 15378 specifies requirements for a quality management system (QMS) for manufacturers of primary packaging materials for medicinal products, integrating ISO 9001 principles with Good Manufacturing Practice (GMP) requirements. The standard focuses on ensuring that packaging materials such as containers, closures, and other components consistently meet quality, safety, and regulatory expectations for pharmaceutical use. It covers areas including risk management, contamination control, traceability, change control, validation, documentation, and supplier management, helping manufacturers demonstrate compliance with both quality and GMP expectations throughout the packaging supply chain.

Benefits:

• Better control over operational uncertainties and safety issues
• Builds a strong professional image and brand credibility
• Increases customer trust and business opportunities
• Provides documented proof of regulatory and contract compliance
• Supports continuous improvement of organizational performance