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最近，印度一藥企在EUGMP檢查中，因?yàn)橐粋€(gè)關(guān)鍵缺陷和兩個(gè)主要缺陷沒(méi)有通過(guò)現(xiàn)場(chǎng)檢查，在缺陷正文中提到了一個(gè)中國(guó)制藥企業(yè)，躺著中槍。

【缺陷翻譯】

Overall, 24 deficiencies were observed during theinspection, 1 Critical and 2 Major deficiencies: * * * 

在檢查中共發(fā)現(xiàn)了24個(gè)缺陷項(xiàng)，其中包括1個(gè)關(guān)鍵缺陷和2個(gè)主要缺陷。

[Critical 1] 

No transfer of information to the user ofthe active substance as regards to the original manufacturers of the activesubstances only micronized at the site (i.e. manufacturer name, original batchnumber and COA) and exported to Europe or that may be sold to distributors exporting to Europe. The following active substances were micronized from othersources (as communicated by the company - may not be exhaustive): Azithromycin,Chloramphenicol, Chloramphenicol Palmitate, Ciprofloxacin HCl, Clarithromycin,Piperaquine phosphate, Roxithromycin and Sulfadoxine. Moreover, a non EU-GMPcompliant source for Azithromycin (NCF/010/RO, Hebei Dongfeng PharmaceuticalCo., Ltd, China) was micronized and directly exported to Europe under themanufacturer name Anuh Pharma. * * *

[關(guān)鍵缺陷1]

僅微粉工序在工廠進(jìn)行的活性物質(zhì)的原始生產(chǎn)商信息（如生產(chǎn)商名稱、原始批號(hào)及CoA）未傳遞給使用者，并且這些物料直接出口到了歐洲或者出售給了出口到歐洲的貿(mào)易商。以下這些被微粉的物料來(lái)自于其他來(lái)源（根據(jù)與公司的溝通，可能不詳盡）：阿奇霉素，氯霉素，棕櫚氯霉素、鹽酸環(huán)丙沙星、羅紅霉素、克拉霉素、磷酸哌喹，磺胺多辛。同時(shí)，一個(gè)不符合EU-GMP來(lái)源的疊氮紅霉素（NFC/010/RO,河北東風(fēng)制藥有限公司，中國(guó)）被微粉粉碎后直接出口到了歐洲的制藥商Anuh Pharma.

[Major 1] 

Deficiencies in documentation management.Several documents were found within a pile of rubble on the other side of awall. These included an original batch repacking record which should have beenplaced under retention and a large number of purchase orders dated from 2013for active substances, notably Azithromycin, Chloramphenicol, ChloramphenicolPalmitate, Roxithromycin and Ciprofloxacin HCl. * * *

[主要缺陷1]

在文件管理方面存在缺陷。在墻的另外一側(cè)的瓦礫中發(fā)現(xiàn)了一些文件。這些文件包括一個(gè)本應(yīng)該被良好保存的重包裝原始批記錄，以及大量自2013年開(kāi)始的活性物質(zhì)采購(gòu)訂單，特別是阿奇霉素，氯霉素，氯霉素棕櫚酸酯、羅紅霉素和鹽酸環(huán)丙沙星。

[Major 2] 

Deficiencies in process validation. Novalidation data was available for the blending of micronized batches. Nocleaning validation was available for one air jet mill used for micronization.No supporting data for the reduced testing of the recovered Ethyl Acetatesolvent was available.

[主要缺陷2]

工藝驗(yàn)證方面存在缺陷。微粉批次的混合沒(méi)有可用的驗(yàn)證數(shù)據(jù)。用于微粉的氣流粉碎機(jī)沒(méi)有進(jìn)行適當(dāng)?shù)那鍧嶒?yàn)證。沒(méi)有可用的數(shù)據(jù)支持回收乙酸乙酯的減少測(cè)試（可能是隔批檢驗(yàn)或者減少檢驗(yàn)項(xiàng)目，譯者注）。