为什么出口的产品，国内监管机构也要求做PQR

beiwei5du · 发表于 2016-10-28 23:44:20

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26. What are the requirements for Product Quality Review (PQR) for products that are for export only?

The PQR requirements for products that are for export only are the same as the PQR requirements for all other products.

为什么出口的产品，国内监管机构也要求做PQR,是出于什么原因考虑的呢？？该问答选自TGA官网。

beiwei5du · 发表于 2016-10-28 23:47:35

PQRs are a requirement in PIC/S Guide for GMP, Clause 1.4.
Regular periodic or rolling quality reviews of all registered pharmaceutical products, including
export only
products, should be conducted to highlight any overall trends (not necessarily visible
with other quality systems) and to identify product/process improvements by verifying and
identifying:
• the consistency of the existing process(es);
• trends in product data;
• the appropriateness of current specifications for starting materials, intermediates and
finished products;
• to verify compliance of the registered particulars of pharmaceutical products (Marketing
Authorisation);
• deficiencies not detected by routine testing, monitoring or performance metrics; and
• identify opportunities for product and process improvements.

静水蓝心 · 发表于 2016-10-29 06:50:23

受教了！

番茄炒蛋 · 发表于 2016-10-29 08:42:09

这个是PIC/S本身的要求吧，原因的话揣测一下：提供工艺得到持续性确认的证据？

叶非 · 发表于 2016-10-29 10:13:46

PQR的要求，是GMP管理的要求，又不仅仅是监管的要求。这个和你产品是否出口，有什么关系？

一沙一叶 · 发表于 2016-10-29 20:41:40

是质量管理体系的要求，不过国内监管应该不会查吧

小金库 · 发表于 2023-2-18 18:45:19

受益匪浅

[GMP相关] 为什么出口的产品，国内监管机构也要求做PQR

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