減少起始物料取樣和檢測的機會

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章生產(chǎn)在去年進行了更新。但是，并不是所有人都真的知道其中有一些具體的信息，是講原料藥和輔料的取樣和檢測可以減少的條件。尤其是第5.35和5.36包括有相關要求，而其中顯示出減少的可能性。

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.

基本來說，制劑生產(chǎn)商負責按上市許可申報文件中所述對起始物料進行檢測。但是，可以使用經(jīng)過批準的起始物料生產(chǎn)商的一部分或全部檢測結果，但至少必須按上市許可申報資料中所述做鑒別項。

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:

如果制劑商選擇外包檢測活動，則必須進行論述和記錄。另外，還必須滿足一些其它的措施要求，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.

要特別注意銷售控制（運輸、批發(fā)、存貯、發(fā)貨），以確保檢驗結果最后還是適用于所發(fā)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.

對起始物料檢測和取樣場所實施基于風險的審計，核實GMP符合性，確認所用的質(zhì)量標準和檢測方法與上市許可資料所述一致。

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.

起始物料的生產(chǎn)商/供應商檢驗報告應有負責人簽名，其應具備適當?shù)馁Y質(zhì)和經(jīng)驗。簽字確認符合協(xié)議的產(chǎn)品質(zhì)量標準。

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.

藥品生產(chǎn)商應具備足夠的處理起始物料生產(chǎn)商的經(jīng)驗----包括之前收到的批評估，以及在減少自己內(nèi)部的檢測之前的符合性歷史。

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.

按照適當?shù)拈g隔，制劑生產(chǎn)商或經(jīng)過批準的合同化驗室必須進行全檢，將結果與原料生產(chǎn)商或供應商的分析報告結果進行比較，檢查其可靠性。如果有差異，則必須進行調(diào)查，采取適當?shù)拇胧?。在完成這些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.

在上述網(wǎng)址可以找到完整的EU GMP指南第5章“生產(chǎn)”。

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