翻译：JULIA 来源：Julia法规翻译
受检公司：Sun Pharmaceutical Industries Ltd.
受检地址：SEZ Unit 1, Plot No. A-41, Ind. Area Phase VIII-A, S.A.S.Nagar, Mohali, Punjab, 160071 India
受检身份：制剂生产商
FEI号：3002807979
检查员：NicoleE. Knowlton/Investigator, Maotang Zhou/CDER Reviewer
检查日期：2018-09-10至 2018-09-14
签发日期：2018-09-14
发布日期：2018-09-24
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 FDAto 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 WE OBSERVED: 检查你公司期间我们发现
OBSERVATION 1 缺陷 1
The quality control unit lacks the responsibility and authority to approve and reject all in-process materials and drug products. 质量部门缺乏批准和拒收所有中间体和制剂的责任和权力。
Specifically, you did not reject the three (b)(4) Tablets (b)(4)mg exhibit batches that failed in-process (b)(4) sampling for (b)(4). Out of Specification Investigation No.283910, 282535, and 285929 approved 30/Jan/2018 shows exhibit batches (b)(4) and (b)(4) failed RSD and mean of each location and batch (b)(4) failed RSD for (b)(4) sampling for (b)(4). The results from these batches was submitted in support of drug application (b)(4) Tablets. Additionally, these results were not submitted in one of the appropriate Sections such as 3.2.P.2.3 (Process Development), 3.2.P.3.3 (Manufacturing Process Descriptions), or 3.2.P.3.4 (Controls of Critical Process Parametersand Intermediates); they were submitted in Section 3.2.P.3.5 (Process Validation and Evaluation).
具体来说，你们没有拒收中控XX样品不合格的3批XX片剂。20180130批准的OOS调查号283910、282535和285929显示申报批次XX和XX每个点的RSD和平均值均不合格，批次XX的XX取样RSD不合格。这些批准的结果均提交给FDA用于支持XX片剂的药品申报。另外，这些结果没有放在适当的部分如3.2.P.2.3（工艺开发）、3.2.P.3.3（生产工艺描述）或3.2.P.3.4（关键工艺参数和中间体控制）中提交，而是放在了3.2.P.3.5部分（工艺验证和评估）。
OBSERVATION 2 缺陷 2
The written stability testing program is not followed. 未遵守书面稳定性试验计划。
Specifically, your stability data is not representative of the intended manufacturing process for (b)(4) Tablets (b)(4)mg. Exhibit batches (b)(4) and (b)(4) failed in process (b)(4) sampling for (b)(4). These batches were placed on stability and data from these batches was submitted in support of drug application (b)(4) Tablets.
To date, your firm has manufactured (b)(4) feasibility/optimization batches on two different compression machines after the three exhibit batches were manufactured. As documented in Feasibility Trial Report of (b)(4) Tablets (b)(4)mg Report No. FSTR/02/1217-00, your firm determined compressed tablets on (b)(4) Compression Machine Model (b)(4) (ID MPDRCM02) will not yield acceptable (b)(4) results. Firm management stated you intended to use (b)(4) Compression machine (b)(4) (ID MPDRCM01) for commercial production of (b)(4) Tablets (b)(4)mg.
具体来说，你们的稳定性数据不能代表XX片剂将要使用的生产工艺。申报批准XX与YY中控XX取样不合格。这些批次被放在了稳定性中，其数据被提交给FDA用于支持XX药品申报。
截止今日，在生产了3批申报批次之后，你公司已在2台不同压片机上生产了XX批可行性/优化批次。正如XX片剂可行性试验报告（编号FSTR/02/1217-00）所记录，你们公司决定在XX型号（ID MPDRCM02）XX压片机上压片不能得到可接受的XX结果。公司管理人员声称你们要使用XX压片机（ID MPDRCM01）用于XX片剂的商业化生产。