关于raw material的检测结果是否包含在PQR中的进行回顾的说明

beiwei5du

关于raw material是否包含在PQR中的进行回顾的说明

As an example, the authors have seen FDA 483s criticizing the failure totrend raw-material test results as part of the PAR for a product. To determinewhether this is a valid FDA 483 observation or whether raw-material trendingshould be included, the following should be considered. If the trending of araw material (e.g., an active ingredient) identifies an adverse trend (e.g.,more than 25% of all lots received in the past 12 months were rejected and sentback to the supplier), would this adverse trend cause the company thatperformed the PAR to change its manufacturing process for the drug product, themanufacturing controls for the drug product, or the final releasespecifications for the drug product? When the answers are "no" to allthree parts of this question, raw-material trending should not be included aspart of the PAR because any result from this trending would not be relevant tothe objectives of the PAR and would not generate any follow-up action forimplementing changes. To avoid confusion, this example is not to suggest thatraw-material trending is not needed, but that it should be performed as part ofanother program (e.g., vendor qualification program) instead of the PAR program. It should be noted that the EU PQR requiresthe evaluation of the appropriateness of the raw-material specifications.

静水蓝心

楼主很专业，可是不明白为什么总是分享片段？

beiwei5du

静水蓝心 发表于 2016-10-29 21:05
楼主很专业，可是不明白为什么总是分享片段？

文章可以在网上收到http://www.pharmtech.com/product ... 1&sk=&date=，主要是分享一下小观点，先提dots，后面再connect，该篇文章是2008年的，里面的一些观点在现在也不一定正确，大家借鉴看即可！

静水蓝心

beiwei5du 发表于 2016-10-29 21:22
文章可以在网上收到http://www.pharmtech.com/product-annualquality-review-us-eu-comparative-analysis ...

嗯，非常感谢，受益匪浅！

zysx01234

关键知道这些有鸟用，一个年报要详细或简单，要看制作的人的能力和其他因素

xqliu

学习一下啦，谢谢提供分享。

2A2MXnrNlF

静水蓝心 发表于 2016-10-29 21:05
楼主很专业，可是不明白为什么总是分享片段？

放了几段英文字的贴就是专业、未免太吹牛吧。

静水蓝心

2A2MXnrNlF 发表于 2016-10-31 07:05
放了几段英文字的贴就是专业、未免太吹牛吧。

说人家专业就是抱着学习的态度去学习
！不喜就不要喷，这是学习交流的平台，不是用来讽刺挖苦别人的，你专业那就你来啊！