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本帖最后由 意林枫 于 2017-5-25 13:12 编辑
昨夜，FDA官网发出对江苏常州金坛前药制药原料药工厂的警告信，缺陷包括：
该警告信摘译如下：
Mr. Zheng Goubin General Manager Changzhou Jintan Qianyao Pharmaceutical Raw Material Factory 常州金坛前药制药原料药工厂 No. 678 Zhuangcheng, Baita Town, 中国江苏省常州市金坛区庄城678号 Jintan District, Changzhou City, China 213200
Dear Mr. Goubin:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Changzhou Jintan Qianyao Pharmaceutical Raw Materials at No. 678 Zhuangcheng, Changzhou, Jintan, from February 13–17, 2017. FDA于2017年2月13-17日检查了你们位于常州市金坛区庄城678号的制药工厂：常州金坛前药制药原料药工厂
This warning letter summarizes significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). 本警告信概括了与原料药CGMP的重大偏差。
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). 由于你们的方法、设施、或者生产、加工、包装或者储存的控制不符合CGMP，你们的原料药被认定为掺假。
We reviewed your March 2017 response in detail. 我们详细审阅了你们于2017年3月的回复。
During our inspection, our investigator observed specific deviations including, but not limited to, the following. 在我们检查期间，我们的检查员发现的具体偏差包括但不限于，如下：
1. Failure to implement a system for managing quality encompassing the organizational structure, procedures, processes and resources, as well as activities to ensure confidence that the API will meet its intended specifications for quality and purity. Failure to define and document all quality-related activities. 未能实施一个系统来管理质量，包括组织架构、规程、流程和资源，以及用以确保原料药的质量和纯度有信心能符合其既定标准的一系列活动。未能定义和记录所有质量相关的活动。
Before August 2016, your firm did not have any quality-related procedures in place even though you were manufacturing and shipping drugs to the United States. Although you had drafted some procedures by the time of our February 2017 inspection, you had not yet implemented any such procedures as of the date of our inspection. 2016年8月之前，贵司没有任何质量相关的规程可用，尽管你们生产并且向美国销售了药品。尽管你们在2017年2月的检查时已经起草了一些规程，到我们检查之日为止，你们还没有实施任何这些规程。
2. Failure to have adequate written procedures for the receipt, identification, quarantine, storage, sampling, testing, handling, and approval or rejection of raw materials. 原材料的入库、鉴别、隔离、储存、取样、检验、处理，以及批准或拒收没有适当的书面规程。
For example, when our investigator asked for a list of your critical raw materials and your sampling requirements, you told our investigator that you had no written procedures for testing and sampling incoming materials. Instead, you explained, your warehouse employees accounted for incoming raw material handling, sampling, and testing “in their heads.” 例如，当我们的检查员想要看你们关键原材料的清单以及你们的取样要求时，你们告诉我们的检查员说你们还没有入库物料的检验和取样的书面规程。反而，你们解释说，你们的仓库员工对入库原料的处理、取样和检验心里清楚的很。
3. Failure to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards. 没有实验室控制记录，包括来自所有实验室检验的用以确保符合既定标准的完整数据。
For example, our investigator reviewed the audit trail from your assay testing for (b)(4) lot (b)(4), and found that you tested the same sample set three times over several days without documentation or investigation. You reported only the result of the third and final test for purposes of completing your certificate of analysis and releasing this batch of API. 例如，我们的检查员审阅了你们XX产品XX批次的含量分析的审计追踪，并发现你们在几天时间内对同一个样品序列检验了三次，也没有记录或者调查。你们仅报告了第三次最终检检验的结果来完成你们的检验报告书并放行了这批原料药。 4. Failure to prepare adequate batch production records and record the activities at the time they are performed. 未能准备充分的批生产记录并实时记录。
For example, our investigator found that your operator used process parameter values from previous batches of (b)(4) to complete new batch records when she was too tired to immediately record the data and had forgotten the values. 例如，我们的检查员发现你们的操作员在他们太累难以立即记录数据和忘记的情况下，使用以前XX产品批次的工艺参数值来完成新的批记录
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发表于 2017-5-25 12:03:13
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