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公司：Chengdu Okay Pharmaceutical Co., Ltd. 成都欧康 地址：No.15 Chuangye Road Linqiong Industrial Zone, Qionglai,Sichuan Province, 611530, China 检查方：波兰药监 原料药 Diosmin地奥司明 检查日期 2015-10-28 Overall, 21 deficiencieswere observed during the inspection, including 5 critical and 10 majordeficiencies. The critical deficiencies were observed in QA Dept. includingcalculation of impurities of Diosmin and there were no records of standard(used as a reference) for testing in –house standard. Also the data integritywas not guaranteed. In manufacturing Dept. presented measuring methods wereinadequate to the results. The condition in clean area was not acceptable forfinal product. 检查期间总共发现21个缺陷，其中5个关键缺陷，10个主要缺陷。关键缺陷是在QA部门，包括成品杂质计算，内控标准检测用的对照品没有记录。数据完整性无法保证。在生产部门，测试方法无法得到结果。成品洁净区的条件不可接受。 Critical deficiencies:关键缺陷 Testing of the finalproduct: There was incorrectly way of calculation the impurities and Diosmincontent. There were no records of prepared in-house HPLC standard. There was noconfirmation of the conditions HPLC analysis. 成品检测：地奥司明杂质和含量计算方法不正确。没有内控HPLC对照品的记录。对HPLC检测条件没有确认。 Computerized systems-documentation and control: There was found in HPLC system that the method waschanged without any sayings of previous method. There were no logins andpasswords to the HPLC system and no procedure for granting permission to accessto the HPLC system. There was no register of persons authorized to access to theHPLC system. On the same computer station there were two different HPLC software. 计算机化系统—文件记录和控制：在HPLC系统中发现检测方法被更改，对之前的方法没有任何说法。HPLC系统没有登录和密码，没有程序来颁布HPLC系统入口许可。HPLC入口没有人员授权登记。同一个计算机站上有两个不同HPLC软件。 Manufacturingdocumentation: Presented measuring methods of pH during the inspection timewere inadequate to the results recorded in the batch report. 生产文件：检查时pH检测所用方法不足将结果记录在批报告中。 Premises: Crude Diosmindrying was carried out in an area which did not provided the appropriateconditions during the discharge from the dryer. 设施：地奥司明粗品干燥是在一个区域内，在干燥器出料时不能保证适当的条件。 Qualification of equipment:Some data of HVAC system qualification had been falsified. 设备确认：HVAC系统验证的一些数据是假造的。 The major deficiencies wereobserved among others: in the warehouse, in the manufacturing documentation andin the production area. 主要缺陷涉及区域有：仓库、生产文件记录和生产区域。
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东欧国家下手更狠！一下子弄这么多关键缺陷出来！
