Qualification Guideline ASTM E2500 revised

GmpForEver

Qualification Guideline ASTM E2500 revised

Qualification Guideline ASTM E2500 revised    Qualification Guideline ASTM E2500 revised The American Society for Testing and Materials (ASTM) norm is one of the requirements referred to when it comes to qualification (and validation). The norm in question has number E2500 and is entitled "Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment". In our GMP News dated 17 December 2007, we reported about the release of this norm. The ASTM norm represents the further development of a "White Paper" from the International Society of Pharmaceutical Engineering (ISPE) on risk-based qualification and should offer a more modern approach of qualification. The classical qualification levels DQ, IQ, OQ, PQ are not mentioned anymore but Subject Matter Experts (SMEs) who should take care of the organisation of verification. Moreover, Good Engineering Practice (GEP) is highly valued. This ASTM norm is also mentioned in a footnote of FDA's latest Guidance on process validation from 2011. ASTM E2500 has now been revised and is now available as "reapproved". However, the newly published guide contains no significant changes. The changes made are rather changes in the form. Thus, those already owning the 2007 version do not necessarily need to purchase the "reapproved" version (as the norm is subject to charges). However, if you are not familiar with the ASTM norm you may want to think about purchasing it. It is available on the ASTM website as well as on the Beuth Verlag.

胜利者

新闻？

GmpForEver

胜利者 发表于 2013-5-17 09:35
新闻？

ASTM对于设备确认法规更新了

雪锋

ASTM e2500修正指标

美国试验和材料学会 (ASTM) 规范学会是指当它来到资格 （和验证） 的要求之一。该规范在已编号 E2500 和题为"规范、 设计和验证、 制药和生物制药生产系统和设备"。在我们的 GMP 新闻日 2007 年 12 月 17 日，我们报道这一准则的释放有关。
ASTM 规范表示"白皮书"的进一步发展，听得从国际社会的制药工程 （全神贯注） 基于风险的资格，应提供资格比较现代的做法。古典资格水平 DQ、 IQ、 OQ、 PQ 不是核查的不再提及但主题事项专家 (Sme 应照顾组织的人)。此外，良好工程实践 (GEP) 是高度重视的。这种 ASTM 规范中亦有提及一个脚注的 FDA 的最新指导过程验证从 2011 年。
ASTM E2500 现在已修订和现已作为"reapproved"。然而，新出版的指南包含没有发生重大变化。所做的更改，而是在窗体中的更改。因此，那些已经拥有的 2007年版本不一定需要购买的"reapproved"版本 （如规范收费）。然而，如果你不熟悉的 ASTM 规范你可能想想购买它。它是可用 ASTM 网站以及 Beuth 出版社。

雪锋

我是用翻译软件翻的，我英语也不是很好。

GmpForEver

谁能提供新的ASTM E2500

野性之吻

胜利者 发表于 2013-5-17 09:35
新闻？

啥意思 ？？？

缶涤大天

看过必回，人品超好！

小草

kanbudong

换天洗地tk

找到好贴不容易，我顶你了，谢了












工业视镜

jianhua5144

提供个E2500的文件看看吧

ZhuJ12

谁能提供一下最新的版本的呀？最好和ISPE Version 2一起

2iso

提供个E2500的文件看看吧