Chapter 5 of the EC GMP Guide for the area of production was already updated last year. However, not everybody really knows that it contains concrete information about the conditions when testing and sampling of APIs and excipients can be reduced. Particularly sections 5.35 and 5.36 include requirements and thus show possibilities for a reduction.

EU GMP指南第5章生(shēng)産在去年進行(xíng)了更新。但(dàn)是，并不是所有(yǒu)人(rén)都真的知道(dào)其中有(yǒu)一些(xiē)具體(tǐ)的信息，是講原料藥和(hé)輔料的取樣和(hé)檢測可(kě)以減少(shǎo)的條件。尤其是第5.35和(hé)5.36包括有(yǒu)相關要求，而其中顯示出減少(shǎo)的可(kě)能性。

Basically, the manufacturers of finished products are responsible for every testing of starting materials as described in the marketing authorisation dossier. Yet, part of or complete test results from the approved starting material manufacturer can be used, but at least their identity has to be tested - as described in the in the marketing authorisation dossier.

基本來(lái)說，制(zhì)劑生(shēng)産商負責按上(shàng)市許可(kě)申報文件中所述對起始物料進行(xíng)檢測。但(dàn)是，可(kě)以使用經過批準的起始物料生(shēng)産商的一部分或全部檢測結果，但(dàn)至少(shǎo)必須按上(shàng)市許可(kě)申報資料中所述做(zuò)鑒别項。

If one chooses to outsource the testing activity to the supplier, this has to be justified and documented. Moreover, a few additional measures have to be fulfilled, like:

如果制(zhì)劑商選擇外包檢測活動，則必須進行(xíng)論述和(hé)記錄。另外，還(hái)必須滿足一些(xiē)其它的措施要求，如：

1. Particular attention should be paid to the distribution controls (transport, wholesaling, storage, delivery) to ensure that ultimately the test results are still applicable to the delivered material.

要特别注意銷售控制(zhì)（運輸、批發、存貯、發貨），以确保檢驗結果最後還(hái)是适用于所發送的物料。

2.Performance of risk-based audits at the sites executing the testing and sampling of starting materials to verify the GMP compliance and to ensure that the specifications and testing methods are used as described in the marketing authorisation dossier.

對起始物料檢測和(hé)取樣場(chǎng)所實施基于風險的審計(jì)，核實GMP符合性，确認所用的質量标準和(hé)檢測方法與上(shàng)市許可(kě)資料所述一緻。

3.The certificate of analysis of the manufacturer/supplier of the starting material should be signed by a designated person with appropriate qualifications and experience. The signature confirms the compliance with the agreed product specification.

起始物料的生(shēng)産商/供應商檢驗報告應有(yǒu)負責人(rén)簽名，其應具備适當的資質和(hé)經驗。簽字确認符合協議的産品質量标準。

4.The medicinal product manufacturer should have adequate experience in dealing with the starting material manufacturer - including assessment of batches previously received and the history of compliance before reducing own, internal testing.

藥品生(shēng)産商應具備足夠的處理(lǐ)起始物料生(shēng)産商的經驗----包括之前收到的批評估，以及在減少(shǎo)自己內(nèi)部的檢測之前的符合性曆史。

5.At appropriate intervals, the medicinal product manufacturer or another approved contract laboratory has to carry out a full analysis to compare the test results with the results of the certificate of analysis of the material manufacturer or supplier, and thus to check their reliability. In case of discrepancy, an investigation has to be performed and appropriate measures taken. The certificates of analysis cannot be accepted until those measures are completed.

按照适當的間(jiān)隔，制(zhì)劑生(shēng)産商或經過批準的合同化驗室必須進行(xíng)全檢，将結果與原料生(shēng)産商或供應商的分析報告結果進行(xíng)比較，檢查其可(kě)靠性。如果有(yǒu)差異，則必須進行(xíng)調查，采取适當的措施。在完成這些(xiē)措施之前不能接受分析報告。

You can access the complete Chapter 5 "Production" of the EU GMP Guide here.

在上(shàng)述網址可(kě)以找到完整的EU GMP指南第5章“生(shēng)産”。

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