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附件为WHO原文及翻译参考稿件，原文官网链接为 https://extranet.who.int/prequal ... gdaoApril2017_0.pdf
https://extranet.who.int/prequal/news?f[0]=field_category%3A36
具体内容如下
WHO Response to the USFDAimport alert issued for Qinhuangdao Zizhu Pharmaceutical Co Ltd, ActivePharmaceutical Ingredient (API) Manufacturing Site WHO对美国FDA发布秦皇岛紫竹药业API生产场所进口禁令的回应 On 8th March 2017, Qinhuangdao ZizhuPharmaceutical was placed on the import alert by the USFDA. 2017年3月8日，秦皇岛紫竹药业被USFDA发布进口禁令。 The Good Manufacturing Practice ( GMP) inspection wascarried out by the USFDA at Qinhuangdao Zizhu Pharmaceutical, No. 10, LonghaiAvenue, Economic Development Zone, Qinhuangdao, Hebei, China 066004 on 28November to 1 December 2016. The inspection found failures in the level ofadherence to cGMP for APIs. In particular, the USFDA inspection team discovereda breach of data integrity related to testing in the Quality Controllaboratory. USFDA于2016年11月28日至12月1日对其河北秦皇岛龙海道10号的原料药生产场所进行了检查。检查发现其不符合原料药的CGMP要求水平。特别是USFDA检查团发现其在QC化验室的检测相关数据完整性有问题。 WHO Prequalification Team (PQT) had inspectedQinhuangdao Zizhu Pharmaceutical in October 2015 for levonorgestrel,mifepristone and ethinylestradiol APIs. The inspection concluded with 5 majordeficiencies including data integrity issues and several minor deficiencies.The manufacturer provided corrective and preventive actions (CAPAs) for alldeficiencies; the inspection was closed as compliant based on the CAPAsprovided by the manufacturer. WHO预确认团队（PQT）于2015年10月检查了秦皇岛紫竹药业，检查覆盖左炔诺孕酮、米非司酮和炔雌醇原料药。检查发现5个主要缺陷，包括数据完整性问题和几个轻微缺陷。生产商提交了所有缺陷的CAPA，根据生产商提供的CAPA，该次检查已关闭，结论为符合要求。 WHO has prequalified two finished pharmaceuticalproducts (FPP) for which the inspected Qinhuangdao Zizhu Pharmaceutical islisted as the levonorgestrel supplier. WHO has also prequalified Mifepristoneand ethinylestradiol APIs manufactured by Qinhuangdao Zizhu Pharmaceutical CoLtd. WHO已经通过了对两个使用紫竹药业生产的左炔诺孕酮生产的制剂（FPP）产品的预确认。WHO还通过了秦皇岛紫竹药业生产米非司酮和炔雌醇原料药的预确认。 To date, WHO-PQT has not received any reports ofquality issues on levonorgestrel tablets from the market. 截止目前，WHO-PQT尚未收到市场上关于左炔诺孕酮的质量问题的任何报告。 WHO action and advice WHO措施和建议 WHO has been in touch with Qinhuangdao ZizhuPharmaceutical Co Ltd. and USFDA to discuss this matter. WHO已与紫竹药业和USFDA就此事进行了接触和讨论。 At the moment, there is no alternative levonorgestrelAPI which has been prequalified by WHO-PQT. WHO-PQT is working closely with theFPP manufacturers to identify additional sources for levonorgestrel. 目前，WHO-PQT还没有对其它左炔诺孕酮原料药进行过预确认。WHO-PQT正与制剂生产商紧密合作，寻找左炔诺孕酮原料药的其它来源。 Meanwhile, FPP manufacturers of prequalified productsthat use levonorgestrel manufactured by Qinhuangdao Zizhu Pharmaceutical arerequested to take additional measures such as comprehensive testing uponreceipt to help ensure that the quality of all batches of levonorgestrel isassured. 同时，使用紫竹所生产的左炔诺孕酮原料药的通过预确认的制剂生产商需要采取附加措施，如全面的接收检测，以帮助确保所有左炔诺孕酮批次的质量。 Until further notice, procurement agencies maycontinue to procure FPPs that contain API produced at Qinhuangdao ZizhuPharmaceutical. The prequalification status of Qinhuangdao Zizhu PharmaceuticalCo Ltd. prequalified APIs (levonorgestrel, Mifepristone and ethinylestradiol)remains unchanged. 在发布后续通知之前，采购代理可以持续采购含有紫竹生产的API的制剂。秦皇岛紫竹药业的预确认状态（左炔诺孕酮、米非司酮和炔雌醇）保持不变。 WHO-PQT is planning to conduct an on-site inspectionof Qinhuangdao Zizhu Pharmaceutical. WHO-PQT正计划对秦皇岛紫竹药业进行现场检查。 WHO will continue to follow up on this issue andprovide updates. WHO将持续跟踪此问题并发布状态更新。
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发表于 2017-7-5 14:15:26
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发表于 2017-7-5 14:23:54
），需要采取相应的措施，避免因为自己以前的检查通过，引起后续制剂生产商的潜在问题。而且文末也说了，WHO要对该厂进行现场检查了。