DIN EN ISO 15378:2012-02

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.