国产成人愉拍精品|亚洲中文字幕va毛片|亚洲成人在线免费观看|国产日韩欧美另类制服丝袜|久久久久国产精品免费网站|亚洲国产成人久久精品图片|无码人妻视频一区二区三区免|亚洲AV无码成人网站久久精品

禁止從印度主要生產(chǎn)商進口
2015-10-23 Medicn

Posted 15 October 2015

The US Food and Drug Administration (FDA) on Wednesday added Indian active pharmaceutical ingredient (API) manufacturer Megafine Pharma's Nashik site in Maharashtra, India, to a list of foreign manufacturing sites banned from sending products to the US.
美國FDA在周五增加印度原料藥生產(chǎn)商Megafine藥業(yè)加進了禁止銷售產(chǎn)品進入美國市場的外國生產(chǎn)商名單。

Megafine, which was hit with an FDA Form 483 back in May at the site, produces 24 APIs for the US market, including for drugs intended to treat Alzheimer's disease, depression, schizophrenia, multiple sclerosis and overactive bladders. The company also produces the same number of APIs for the EU market, as well as a number of other products for Canada, Australia, Brazil, Mexico and South Korea. The Nashik site, according to the company, has been inspected and approved by regulators including the European Medicines Agency, Japan's Pharmaceutical and Medical Devices Agency, the WHO and others.
Megafine，在5月已經(jīng)收到了FDA現(xiàn)場的483表，為美國生產(chǎn)24種原料藥，包括旨在治療阿爾茨海默氏癥、抑郁癥、精神分裂癥、多發(fā)性硬化癥和膀胱過動癥。公司也歐盟市場生產(chǎn)同樣數(shù)量的原料藥，也為加拿大、澳大利亞、巴西、墨西哥和南韓生產(chǎn)一定數(shù)量的其他產(chǎn)品。該公司Nashik場地已經(jīng)接受并被包括歐盟、日本、WHO和其他多個官方機構(gòu)批準。

The notice on Megafine does not indicate the specific issues that caused the import alert and does not indicate if the company's other manufacturing site in Vapi, India will be impacted.
對Magafine的通知沒有顯示引起進口警告的特別問題也沒有顯示該公司在印度Vapi的其他生產(chǎn)場地是否被影響。

Form 483 FDA

According to a heavily redacted 13-page Form 483, the company was cited for manipulating lab tests, as well as unjustified and unrecorded deviations from written lab mechanisms. The 483 notes that one of the company's quality control (QC) analysts "manipulated" a test chromatogram "by removing the unwanted peak out of the chromatogram and passed off the passing chromatogram as the valid result."
按照經(jīng)過修訂的多達13頁的483表，該公司偽造了試驗室測試以及未證明和未記錄書面的實驗室機制的偏差。483表注意到該公司一個QC分析員“通過去刪除色譜圖中不想要的色譜峰并將該色譜作為合法的結(jié)果”“偽造”一個測試色譜圖。

In addition, the FDA inspector found that the QC management could not explain the "wide variation between" an initial test result and a retest result, though, “It is believed that the initial OOS [out of specification] assay was switched with old passing sample vials and retested to obtain the passing test results."
另外，F(xiàn)DA檢查員還發(fā)現(xiàn)QC管理不能解釋初始測試結(jié)果和重新測試結(jié)果之間的“很大差異”，不過，“相信初始的OOS（超標）含量已經(jīng)用老的放行的樣品進樣替換了并重新測試得到了通過的測試結(jié)果”。

Another QC analyst was cited for manipulating high-performance liquid chromatography software "to obtain passing test results."
另一個QC分析員被發(fā)現(xiàn)偽造了HPLC色譜軟件“以獲得一個通過的測試結(jié)果”。

In addition, FDA found that no "investigation reports were initiated after identification of non-cGMP [current good manufacturing practice] practices within the production and quality control department."
另外，F(xiàn)DA還發(fā)現(xiàn)“在生產(chǎn)和QC部門發(fā)現(xiàn)了非cGMP行為后沒有調(diào)查報告”。

Companies on the import alert list that would like to request removal, according to FDA, "should provide information to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance. This may include a letter detailing its corrective actions, accompanied by documentation."
想要在進口警告清單中去除的公司按照FDA”應(yīng)該向FDA提供信息充分證明生產(chǎn)商已經(jīng)解決了導(dǎo)致違規(guī)行為出現(xiàn)的條件以便官方相信未來進入將是合規(guī)的。這可能包括一封詳細描述糾正措施并附有文件的申請信。

Forty-five other Indian pharmaceutical and API manufacturers are currently included on the import alert list, including Ranbaxy, Wockhardt and Ipca Laboratories.
45家其他印度的藥品和原料藥生產(chǎn)商目前已經(jīng)在進口警告清單中，包括Ranbaxy、Wockhardt和PCA。

Megafine did not respond to a request for comment.
Megafine沒有對評論做出反饋。