DIN EN ISO 15378
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2011); German version EN ISO 15378:2011
Primärpackmittel für Arzneimittel - Besondere Anforderungen für die Anwendung von ISO 9001:2008 entsprechend der Guten Herstellungspraxis (GMP) (ISO 15378:2011); Deutsche Fassung EN ISO 15378:2011
Overview
The realization of Good Manufacturing Practice (GMP) principles in production and control of primary packaging materials is of great importance for the safety of a patient using the medicinal product, because of their direct product contact. The application of GMP for pharmaceutical packaging materials shall ensure that these materials meet the needs and requirements of the pharmaceutical industry. The standard identifies GMP principles and specifies requirements for a quality management system applicable to primary packaging materials for medicinal products. It is an application standard for the design, manufacture and supply of primary packaging materials, which contains all requirements of DIN EN ISO 9001:2008 and connects these with the relevant GMP requirements of the manufacturer of the medicinal product. The 2007 edition of DIN EN ISO 15378 has been revised in that the standard has been brought in line with DIN EN ISO 9001 from 2008. The standard has been prepared by ISO/TC 76 "Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use" (secretariat: DIN) and has been adopted as a European Standard by the CEN/CENELEC Management Centre, Belgium. At DIN, Working Committee NA 063-02-11 AA "QS-Systeme für Primärpackmittel" ("Quality management systems for primary packaging") of NAMed is responsible.
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 176-01-06 AA - Quality management systems for primary packaging