翻译：JULIA 来源： Julia法规翻译
受检公司：Lupin Ltd.
受检地址：28-1,Midc Industrial Area, Chikalthana, Aurangabad, Maharaahtra, 431210, India
受检身份：Manufacturer of Finished Drugs制剂生产商
FEI号：3004995645
检查员：RuamcyC Penn/Investigator
检查日期：2019-05-06 至 2019-05-15
签发日期：2019-05-15
发布日期：2019-05-22
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 actionwith 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 INSPECTIONOF YOUR FIRM WE OBSERVED: 检查你公司期间我们发现
OBSERVATION 1 缺陷 1
Written records of investigationsin to unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.未能解释的差异以及产品批次或其组份不符合标准的书面调查记录有时无结论或无跟踪。
Specifically, 具体来说，
Your firm has notdocumented completed investigations for the following:
你公司未完整记录以下调查：
A. From July 2017 until February 2019, there were (b)(4) cases ((b)(4) cases of (b)(4)mg; (b)(4) cases of (b)(4)mg; (b)(4) cases of (b)(4)mg) where the In-Process Control (b)(4) testing of (b)(4) tablets yielded out of specification results. Retesting was conducted but no corrective actions were taken at the time including conclusions of “No assignable cause” or “Manual Error” without documentation of the manual error. The (b)(4) tester and formulation were changed in January and August 2018, but no CAPA was developed and no follow-up action was assigned.
自2017年7月至2019年2月，共有XX起中控XX检测结果超标。进行了复测，但当结论为“未找到可归结原因”或“人为错误”时未采取纠正措施，未记录下人为错误。XX检测仪和处方于2018年1月和8月进行了变更，但未制订CAPA亦未指定跟踪措施。
B. No investigation was initiated for the discrepancy found with the (b)(4) Tablet Compressor showing an out of range compaction force in the end protocol compaction force statistics versus the operating messages in (b)(4)mg batch (b)(4) (finished goods batch (b)(4)).
发现压片机XX的压力超范围时未启动调查。
C. Complaint DPC-AU-261-18-0016 consisted of human hair being embedded within an (b)(4) mg tablet. There was no expansion of the investigation to determine microbial contamination and impact.
投诉DPC-AU-261-18-0016说XX片剂里嵌有人发，未将调查扩展至微生物污染检测和影响。
OBSERVATION 2 缺陷 2
Laboratory controls do notinclude the establishment of scientifically sound and appropriate specifications, sampling plans and test procedures designed to assure that components, in-process materials and drug products conform to appropriate standards of identity,strength, quality and purity.实验室控制未包括建立科学合理和恰当的质量标准、取样计划和检测方法，用以确保组分、中间体和成品符合适当的均一性、含量、质量和纯度标准。
Specifically, 具体来说，
Growth promotion isdeficient in that (b)(4) average colony counts obtained from the certificates of analysis are used to accept new media rather than using actual counts obtained from verified, already accepted media. This process has not been validated to show at least equivalency to USP methods.
促生长试验有缺陷，COA上的XX平均菌落计数被用于接受新的培养基，而未使用已验证已接受的培养基所得的实际计数结果做判定。该程序未经过验证证明其至少等同于USP方法。
OBSERVATION 3 缺陷 3
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. 未建立收率监测控制程序，未验证可能导致中间体和成品特性变化的生产工艺性能。
Specifically, 具体来说，
A. Temperature mapping studies were conducted onthe finished drug product warehouses (b)(4) but did not use the data to scientifically justify the placement of the temperature data loggers. The loggers were not placed in the hot spots derived from the studies. The variability for the movement of the shelves was also not taken into account during the studies.
制剂成品仓库XX做了温度分布研究，但未使用这些数据来科学论证温度记录仪的放置点。记录仪未放在研究所结论的最热点。在研究中亦未考虑货架移动的变化。
B. Yield limit specifications have not been established for critical manufacturing steps such as in-process (b)(4) of (b)(4)mg and (b)(4) capsules. The process was stated to have been validated but (b)(4) commercial batches would be needed to validate the yield specification.
关键生产步骤如XX胶囊的中间步骤未制定收率限度标准。公司声称该工艺已经过验证，但XX商业批次需要验证其收率标准。
DATES OF INSPECTION 检查日期
2019-05-06 至2019-05-10 （周一至周五）2019-05-13 至2019-05-15（周一至周三）
