关于产品质量回顾频度的要求

恨我不成钢

欧洲药监局（EMA）近日在其官网上发布其新的问答，关于欧盟GMP指南第一部分：药品的基本要求：第1章：药品质量体系（2018年7月新版），关于年度回顾频度：

What should be the frequency of the product quality review (PQR)?

产品质量回顾的频度应该是多少？

The product review is expected annually. Review timeframes can be appropriately adjusted based upon manufacturing and campaign duration with adequate justification. The timeframe criteria should be established in a SOP. The trending can include results gathered from the previous period to ensure its robustness. Even if no manufacturing has occurred in the review period, the quality and regulatory review should be conducted as per section 1.10 and include stability results, returns, complaints, recalls, deviations (including those arising from qualification and validation activities) and regulatory background. The review of the last PQR should also be conducted.

产品质量回顾期望的频度是每年。在有充分理由的情况下，也可以根据生产周期适当调整。应在SOP中建立可调整时间的标准。趋势可以包括从前一时期收集的结果以确保其稳健性。即使在回顾期间没有生产，质量和监管回顾也应按照第一章1.10节进行，包括稳定性结果，退货，投诉，召回，偏差（包括确认和验证过程产生的偏差）和监管背景。还应对最后一次PQR进行审查。

并肩

好像没什么新意呢

18362192280

明确了一下吧，这是

wsx

有新意，回顾期限内没有生产的要求。
Even if no manufacturing has occurred in the review period, the quality and regulatory review should be conducted as per section 1.10 and include stability results, returns, complaints, recalls, deviations (including those arising from qualification and validation activities) and regulatory background. The review of the last PQR should also be conducted.

qixintec

为什么只有一段