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受检公司：Zhejiang Huahai Pharmaceutical Co., Ltd. 浙江华海药业 受检地址：Xunqiao, Linhai, Zhejiang 317024, China 中国浙江临海汛桥 受检身份：制剂和原料药生产商 FEI号：3003999190 检查员：Justin A, Boyd, Investigator / Peter E.Baker, Investigator 检查日期：2016-011-14 至 2016-11-18 签发日期：2016-11-18 发布日期：2018-08-09 This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations. And do not represent a final agency determination regarding your compliance if you have an objection regarding an observation, or have implemented, or plan to implement corrective action in response to an observation, you may discuss the objection or action with the FDA representative(s) during the inspection or submit this information to FDA to address above. If you have any questions, please contact FDA at the phone number and address above. 本文件列出了FDA代表在对你工厂检查期间所发现的问题。这些只是检查发现，并不代表FDA对你公司合规性的最终结论。如你们对某一缺陷有异议，或已实施或计划实施纠正措施来纠正某个缺陷，你们在检查期间与FDA代表讨论你们的异议与措施，或通过上述地址向FDA提交资料。如有问题，请通过上述地址电话与FDA取得联系。 DURING AN INSPECTION OF YOUR FIRM WEOBSERVED: 检查你公司期间我们发现 OBSERVATION 1 缺陷1 Written procedures designed to prevent contamination of drug products purporting to be sterile are not followed. 未遵守设计用以防止理应无菌的药品交叉污染的书面程序。 1. Intervention during filling operations have not been defined in procedures and were not documented in the (b)(4) submission batch records. 程序中未定义在灌装操作期间的干预，亦未记录在XX申报批记录中。 3. No defect set of vials is maintained for training and qualification of the visual inspection process. 未制作目检操作培训和确认用缺陷西林瓶系列。 OBSERVATION 2 缺陷2 Failure to establish laboratory controls that include scientifically sound and appropriate specifications, standard sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.. 未建立化验室控制使其包括科学合理适当的质量标准、标准取样计划和检测方法用以确保药品符合适当的鉴别、剂量、质量和纯度标准。 1. Environmental monitoring media for air, surface, and personnel monitoring does not contain any neutralizer for the disinfectants used in the clean room. 环境监测中空气、表面和人员监测用培养基并不含有任何洁净间所用消毒剂的中和剂。 3. Monitoring of the unfiltered bulk compounded batch does not include evaluation for endotoxin and the samples are collectedat least (b)(4) prior to the start of (b)(4). 对过滤前配制药液的监测没有内毒素项目，在XX开始之前至少取样XX。 5. Limits on reject type are not established inthe visual inspection procedures. 目检程序中未设定拒收类型的限度。 OBSERVATION 3 缺陷3 Processing areas are deficient regarding the system for cleaning and disinfecting the equipment. 工艺区域的设备清洁和消毒系统有缺陷。 1. (b)(4) of the filling room is done (b)(4) to control spores with a (b)(4) solution. The validation of the (b)(4) process didnot include placement of biological indicators in hard to reach areas, such asin RABS (b)(4) areas that may be clocked by equipment, high areas or low areas.灌装间的XX已完成用以使用XX溶液控制孢子。XX工艺的验证未包括在难接近区域放置生物指示剂，例如在可能被设备阻碍的RABS的XX区域、较高区域或较低区域。 3. Transfer of the filling machine (b)(4) parts from their storage in unclassified areas to the Grade A areas was not evaluated in the validation “Efficiency Qualification of Material Transferring by Non-Sterilization Method into Grade B”. 验证“非灭菌方法转移物料至B级区的有效性确认”中未评估灌装机XX部件从其非洁净区存贮处转移至B级区的操作。 OBSERVATION 4 缺陷4 Data is not recorded contemporaneously. 数据记录不同步。 1. The QC analyst responsible for environmental monitoring does not document sampling at the time it occurs. It was reported the analyst remembers the times and documents all at once after finishing. 负责环境监测的QC化验员未在取样时即行记录。报告说化验员凭记忆记下时间然后在完成之后全部写下来。
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