【讨论】年度产品质量回顾的重要性（APQR/ APR/ PQR）的质量改进方法

清歌一曲月如霜

【讨论】Importance of Annual Product Quality Review (APQR/APR/PQR) in Quality Improvemen

Nov 17, 2013

Know the importance of Annual Product Quality Review (APQR) in pharmaceutical manufacturing and guidelines of different regulatory agencies on APQR.

Annual Product Quality Review is prepared in pharmaceutical to review consistency of the products annually regarding their quality including the deviations, change controls and market complaints. It is used as an effective product quality improvement tool.
Annual Product Review verifies the consistency of the existing manufacturing process. It also helps to determine the quality and process defects of the products. It determines the defects and possible improvements of the method and process. Trend of the yield, analytical results, manufacturing parameters of the products are also highlighted.

It reviews the quality of raw material and packing material used for the product. Trend of these materials indicates the quality of the material and the supplier also. In-process and the finished product results are reviewed to determine the consistency of the product quality.
Quantity of the final product is reviewed by the trending the yield of every batch. Out of specification helps to determine the process defects during the production of the specific product. Failure of batch is also included in APQR to determine the batch rejection of the product. Stability study and its trend help to determine the defects regarding the product stability.
APQR helps to determine the need of re-validation of the process and effect of any improvement made previously. Corrective and preventive actions and their impact on product quality are also reviewed and determined.
Annual Product Quality Review is a mandatory requirement of Good Manufacturing Practice. FDA uses the term “Annual Product Review” (APR) while “Product Quality Review” (PQR) term is used in EU-GMP guidelines.
According to 21 CFR 211.180 (e) all finished products should reviewed annually for the quality standards to determine the need of the change in specification or manufacturing of drug product. Market complaints and product recalls should also be reviewed annually. view guideline
PIC/S guidelines state to conduct and document periodic review of the pharmaceutical products annually. Starting and packing material, critical in-process controls, failed batch and their investigation, deviations and changes carried out in the process and analytical procedure should be included in Annual Product Review.
Like other guidelines ICH Q7 too states that Quality Product Review should be conducted annually and reason for the corrective action should be documented and completed in time. view guideline
APQR preparation is not mandatory in WHO GMP but all other regulatory agencies have given notification to prepare the APQR.

2013年11月17日

了解年度产品质量回顾（ APQR ）在医药制造业和不同的监管机构对APQR指引的重要性。

乃制药年度产品质量回顾检讨每年就其质量偏差，变更控制和市场投诉的产品的一致性。它是用来作为一种有效的产品质量改进工具。
产品年度审核验证现有的制造过程中的一致性。这也有助于确定的产品的质量和工艺缺陷。确定的缺陷和可能的改进的方法和过程。趋势产量，分析结果，制造产品的参数也得到强调。

审阅用于产品的原材料和包装材料的质量。这些材料的发展趋势表示的材料的质量和供应商。过程和成品结果进行审查，以确定产品质量的一致性。
最终产品的数量趋势每批产量审阅。超出规定范围，有助于确定特定产品的生产过程中的工艺缺陷。批次的故障，还包括在APQR确定批次拒收产品。稳定性研究及趋势，帮助确定产品的稳定性方面的缺陷。
APQR帮助，以确定是否需要重新验证以前所做的任何改进的过程和效果。纠正和预防措施以及他们对产品质量的影响也检讨及厘定。
年度产品质量回顾是良好生产规范的强制性要求。 FDA采用“年度产品回顾” （ APR ） ，而“产品质量回顾” （ PQR ）术语在欧盟GMP指南。
根据21 CFR 211.180 （e）所有成品应每年检讨的质量标准，以决定是否需要药物产品的规格或制造的变化。市场投诉和产品召回也应每年进行检讨。查看指引
PIC / S的指引列明进行和记录的医药产品，每年定期检讨。启动和包装材料，关键过程控制，不合格批次产品，他们的调查，开展的过程和分析过程中的偏差和变化中应包括产品的年度审核。
像其他指引ICH的Q7也指出，应每年进行一次质量产品评论和纠正行动的原因，应当记录，并及时完成。查看指引
APQR准备在WHO的GMP ，但不是强制性的，所有其他监管机构的规定发出通知，准备APQR 。

十字路口

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ylq31166

学习学习谢谢分享

beiwei5du

为什么国内在法规层面不对起始物料（原辅料和包装材料）等进行年度回顾,而只对原辅料变更进行年度回顾呢？？？个人觉得在我国供应商体系还没有成熟情况下，还是最好规定起始物料的年度回顾吧，但靠通过“供应商审计”来实现会好么？

入不了门者

beiwei5du 发表于 2015-3-3 16:40
为什么国内在法规层面不对起始物料（原辅料和包装材料）等进行年度回顾,而只对原辅料变更进行年度回顾呢？ ...

成品回顾了还做原辅料干嘛，不是多此一举吗。原辅料回顾出来的问题最后肯定也会在成品中体现，不是做重复工作吗

小美2005

也就是APR、PQR、APQR意思差不多，都是年度质量回顾？

石勒

学习学习！感谢分享