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(轉(zhuǎn)）20160302 ECA新聞：中國和印度原料藥生產(chǎn)商欺詐和主要GMP違規(guī) 已有1人參與
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2樓2016-08-24 10:55:08
shidongke
金蟲 (著名寫手)
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20160302 ECA新聞：中國和印度原料藥生產(chǎn)商欺詐和主要GMP違規(guī) GMP News 02/03/2016 Fraud and Major GMP Violations at API Manufacturers in India and China 中國和印度原料藥生產(chǎn)商欺詐和主要GMP違規(guī) The Non-Compliance reports in the Eudra-GMDP database of the European Medicines Agency (EMA)are - to a certain extent - the European counterpart of FDA's Warning Letters. These reports are first drawn up then put in the database after a GMP inspection performed by a representative of the European national competent authorities at an API or medicinal product manufacturer showed serious GMP deficiencies. Similar to Warning Letters, the consequences of Non-Compliance reports are for the companies concerned critical, e.g. withdrawal of the GMP certificate or product recalls. EMA的歐盟GMDP數(shù)據(jù)庫里的不符合報(bào)告是----某種程度上----歐洲版的FDA警告信。這些報(bào)告在歐洲國家藥監(jiān)局對原料藥或制劑生產(chǎn)商的GMP檢查中發(fā)現(xiàn)嚴(yán)重GMP缺陷后先寫就，然后放進(jìn)數(shù)據(jù)庫。與警告信相似，不符合報(bào)告的對于公司來說是關(guān)鍵的，例如，吊銷GMP證書或召回產(chǎn)品。 Two Non-Compliance reports issued at the end of last year concerned API production sites in China and India. 中國和印度有2份不符合報(bào)告在去年年底公布。 Regarding the Chinese manufacturer "Minsheng Group Shaoxing Pharmaceutical Co. Ltd", GMP inspectors from the French competent authority found 2 critical and 4 "major" deficiencies. Those deficiencies are summarised below: 關(guān)于中國的生產(chǎn)商“民生集團(tuán)紹興藥業(yè)有限公司”，來自法國藥監(jiān)的GMP檢查員發(fā)現(xiàn)2個(gè)關(guān)鍵4個(gè)主要缺陷。這些缺陷總結(jié)如下： • Falsification of source of starting materials: the starting materials supposed to have been manufactured in-house actually came from an external non GMP-compliant supplier and have been repackaged and relabelled accordingly (critical deficiency). • 原料藥來源做假：起始物料應(yīng)該是公司內(nèi)部自己生產(chǎn)的，而實(shí)際是來自外部非GMP符合的供應(yīng)商，并且進(jìn)行了相應(yīng)的重新包裝和重新標(biāo)簽（關(guān)鍵缺陷） • The API manufactured according to the Chinese Pharmacopoeia was wrongly and intentionally released as USP quality; there was no traceability of the testing activities (critical deficiency). • 根據(jù)中國藥典生產(chǎn)的原料藥錯(cuò)誤地有意作為USP質(zhì)量放行，沒有檢測活動可供追溯。（關(guān)鍵缺陷） • The cleaning and maintenance operations of the manufacturing line were insufficient (major). • 生產(chǎn)線的清潔和維護(hù)不充分（主要缺陷） • Deficient equipment design (pipelines); non-compliant transfer of the intermediate solution using nitrogen; non-compliant change management with regard to equipment (major). • 設(shè)備設(shè)計(jì)有缺陷（管線）、中間體溶液使用氮?dú)鈧魉筒缓弦?guī)、設(shè)備變更管理不合規(guī)（主要缺陷） • Hoses were lying on a dirty floor of an area not mentioned in the general layout of the site. Those hoses were unidentified and their cleaning status was unclear (major). • 軟管放在臟的地面上，該區(qū)域在工廠總平圖上沒有提到。這些軟管沒有標(biāo)識，其清潔狀態(tài)不清楚（主要缺陷） • Audit trail function in the chromatographic system was deactivated; there was no procedure in place for audit trail (major). • 色譜系統(tǒng)的審計(jì)追蹤功能沒有激活，沒有審計(jì)追蹤程序（主要缺陷） By the way, the inspection of the Chinese manufacturer performed by the French authority was part of the prequalification programme of the WHO which means that it had been initiated by the manufacturer himself within the framework of his application for the inclusion of his products in the list of prequalified pharmaceutical APIs of the WHO. 順便說一下，法國藥監(jiān)對中國生產(chǎn)商的檢查是WHO預(yù)確認(rèn)程序的一部分，這表示該檢查是由生產(chǎn)商自己激活的，意在將其產(chǎn)品包括在WHO的預(yù)確認(rèn)原料藥清單上。 Secondly, the inspection of the Indian company "AstraZeneca Pharma India Ltd." was carried our by inspectors of the Swedish competent authority. The GMP deviations observed are summarised below: 第二個(gè)是由瑞典藥監(jiān)對印度公司“阿斯利康藥業(yè)印度公司”的檢查。發(fā)現(xiàn)的GMP偏差總結(jié)如下： • The manufacturing process of the API was not sufficiently validated (major). • 原料藥生產(chǎn)工藝未經(jīng)過充分驗(yàn)證（主要缺陷） • The documentation routine was not GMP-compliant (major). • 文件記錄常規(guī)做法不合規(guī)（主要缺陷） • Data integrity wasn't assured (major). • 未保證數(shù)據(jù)完整性（主要缺陷） • Design and maintenance of the equipment was insufficient (major). • 設(shè)備的設(shè)計(jì)和維護(hù)不充分（主要缺陷） The GMP deficiencies discovered in both production sites concern essential GMP requirements for the manufacture of APIs as laid down in the ICH Q7 Guideline and in the EG GMP Guide Part II since already 16 years. Unfortunately, GMP inspectors from European authorities, the EDQM and the FDA are - again and again - confronted to such GMP deficiencies, mainly in Indian and Chinese manufacturing sites. 在兩個(gè)生產(chǎn)工廠里發(fā)現(xiàn)的GMP缺陷關(guān)系到基本的GMP要求，是ICH Q7指南和EU GMP指南第二部分16年之前就制訂的原料藥生產(chǎn)要求。不幸的是，歐洲藥監(jiān)GMP檢查員，EDQM和FDA一而再，再而三地面對這樣的GMP缺陷，主要是在印度和中國生產(chǎn)工廠。 |
3樓2016-08-24 10:55:33
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