药品质量回顾频次

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欧盟最新问答，关于质量回顾频次，然而不知道怎么截图，只好复制下来了，原话如下

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


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.

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谢谢分享。