DIN EN ISO 15378:2016-03

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 standard contains a technical revision of the edition DIN EN ISO 15378 from 2012. Major changes include the integration of requirements for risk management and the complete revision of the guidelines for verification, qualification and validation. The standard has been prepared by ISO/TC 76 "Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use" (secretariat: DIN). At DIN, Working Committee NA 063-02-11 AA "QS-Systeme für Primärpackmittel" ("Quality management systems for primary packaging") of DIN Standards Committee Medicine (NAMed) is responsible.