DS/EN ISO 15378-2012

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

非常抱歉，我們暫時無法提供預覽，您可以試試： 免費下載 DS/EN ISO 15378-2012 前三頁，或者稍后再訪問。

如果您需要購買此標準的全文，請聯系： 。

注意： 點擊下載后，生成下載文件時間比較長，請耐心等待......

標準號

DS/EN ISO 15378-2012

發布日期

2012年03月01日

實施日期

2012年03月01日

廢止日期

無

國際標準分類號

11.040.01

發布單位

DK-DS

被代替標準

DS/EN ISO 15378-2007

適用范圍

This International Standard specifies 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.In this International Standard the term “if appropriate” is used several times. When a requirement is qualified by this phrase, it is deemed to be “appropriate” unless the organization can document a justification otherwise.