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I.S. EN ISO 15378:2015現行

Primary Packaging Materials for Medicinal Products - Particular Requirements for the Application of iso 9001:2008, With Reference to Good Manufacturing Practice (gmp) (iso 15378:2015)

出版:National Standards Authority of Ireland

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基本信息
標準編號: I.S. EN ISO 15378:2015
發布時間:2015/11/22 0:00:00
標準類別:Standard
出版單位:National Standards Authority of Ireland
標準頁數:84
標準簡介

Defines requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.

本標準替代的舊標準

I.S. EN ISO 15378:2007