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EN ISO 15378 Primary Packaging Materials for Medicinal Products


Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)


EN ISO 15378 is a standard for primary packaging based on ISO 9001 (quality) and has been developed especially for manufacturers of packaging materials for pharmaceutical/medicinal products. In addition to the standard requirements to the quality management systems for design/development, production, customer service and assembly, it defines a number of additional criteria applicable to the primary packaging industry: Traceability and documentation, controlled environmental conditions, validation/qualification and risk management. It covers all GMP Principles (GMP = Good Manufacturing Practice), which are commonly used in the production of primary packaging materials.

The current version of ISO 15378 is based on ISO 9001:2008. However, a draft standard (ÖNORM EN ISO 15378:2016 11 15) correlating with ISO 9001:2015 is already being prepared.

ISO 15378 specifies requirements for a quality management system when an organization

(A) demonstrates its ability to consistently provide products and services that meet customer requirements and the applicable legal and regulatory requirements;

(B) strives to increase customer satisfaction through effective application of the system, including the process of improving the system and assuring compliance with customer requirements and applicable legal and regulatory conditions.

Manufacturers of primary packaging materials in the medicinal / pharmaceutical sector and their suppliers.

All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

This International Standard incorporates the requirements of ISO 9001:2008 and, additionally, particular requirements for primary packaging materials, which are derived and adapted as appropriate from Good Manufacturing Practices for the production and control of medicinal products.

The audit procedure and the issuing of certificates are handled as in audits according to ISO 9001.

ISO 9001, ISO 22000, FSSC 22000, BRC Packaging, BRC – Global Markets Programs, IFS PACsecure, EN 15593, FEFCO GMP


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Mr. Wolfgang Leger-Hillebrand

Executive Vice President Sector Management Food Safety

Mr. Dr. Johannes Bergmair

Network partner, Product Expert Packaging