1. Your firmfailed to have, for each batch of drug product, appropriate laboratorydetermination of satisfactory conformance to final specifications for the drugproduct, including the identity and strength of each active ingredient, priorto release (21 CFR 211.165(a)). 你们公司对每批药品进行适当的化验室测试，确保其在放行之前符合药品的最终标准，包括每种活性成分的鉴别和剂量(21 CFR 211.165(a))。 You released over-the-counter(OTC) (b)(4) drug products without data to support their conformance tospecifications (e.g., strength). During our investigator’s review of batchrecords for five of your OTC products, you could not provide analytical data tosupport the release of these products. One of your lab personnel also statedthat you did not test every lot of finished products prior to release. 你们没有数据支持其符合质量标准（例如剂量）即放行了OTCXX药品。在我们的调查人员对你们5个OTC药品批记录审核期间，你们未能提供分析数据来支持这些产品的放行。你们一个化验室人员还说你们在放行每个批次制剂产品之前都不检测。 2. Your firmfailed to ensure that laboratory records included complete data derived fromall tests necessary to assure compliance with established specifications andstandards (21 CFR 211.194(a)). 你们公司未能确保化验室记录中包括所有必须测试中所生成的完整数据，这些测试是为了确保产品符合其既定标准(21 CFR 211.194(a))。 Our investigator documentedmultiple examples of falsifying laboratory records. Your quality controllaboratory employee stated that he fabricated laboratory data for untestedfinished drug products by manipulating electronic laboratory records. Forexample, he changed the file names for test results of previously tested drugsso that the file names appeared to reflect the results of other lots ofproduct. Your firm used this falsified laboratory data to determine thestrength of your OTC (b)(4) drug products. Your response stated thatyour quality assurance manager instructed laboratory analysts to manipulate,falsify, or fabricate data. 我们的调查人员记录下了多个伪造化验室记录的例子。你们的QC实验室员工说他通过捏造电子实验记录为未曾检测的药品伪造实验室数据。例如，他改变了之前检测过的药品的检测结果的文件名，这样该文件名看起来反映的是另一些批准药品的结果。你们公司使用这些伪造的化验室数据来决定你们OTC XX药品的剂量。你们在回复中声称说你们的QA经理指示化验员捏造、伪造或虚构数据。 3. Your firm’squality control unit failed to review and approve all drug product productionand control records to determine compliance with all established, approvedwritten procedures before a batch is released or distributed (21 CFR 211.192). 你们公司的质量控制部门未能审核和批准所有药品生产和检测记录来确定产品在放行或销售之前是否符合所有既定的经批准的书面程序(21 CFR 211.192)。 Your OTC sunscreen drugproduct, (b)(4), contains (b)(4) active ingredients: (b)(4).Your batch records for lot (b)(4) of this product included concentrationvalues for these active ingredients that did not match the data found in yourinstruments. You used the inaccurate data reported in your batch records tocalculate potency results that were within specification, and you relied onthese inaccurate results to release your product. However, when we used theinstrument data instead of the results in your batch records to perform thesame calculations, we found that the lot was out-of-specification (OOS)(superpotent) for (b)(4) active ingredients. Your quality unit did notidentify this discrepancy prior to releasing this lot. 你们的OTC防晒药品XX中含有XX活性成分：XX。你们XX批次该药品的批记录包括有这些活性成分的浓度值，与在你们仪器中发现的数据并不相符。你们使用了不准确的数据报告在你们的批记录中用以计算得到符合质量标准的含量结果，你们依赖这些不准确的结果来放行你们的产品。但是，当我们使用仪器中的数据替代你们批记录中的数据来进行相同的计算时，我们发现该批次的XX活性成分是OOS（超过效价）。你们的质量部门在放行此批准时并未发现此分歧处。 4. Your firmfailed to exercise appropriate controls over computer or related systems toassure that only authorized personnel institute changes in master productionand control records, or other records (21 CFR 211.68(b)). 你公司未能对计算机和相关系统执行恰当的控制以确保只有经过授权的人员才可以修改主生产和检测记录以及其它记录(21 CFR211.68(b))。 Laboratory equipment used togenerate analytical data for release purposes lacked restricted access. Forexample, analysts shared usernames and passwords, and all users hadadministrator rights that permitted them to delete or modify files inhigh-performance liquid chromatography and gas chromatography equipment.You had no mechanism to facilitate traceability of the individuals who changed,adjusted, or modified data generated by computerized systems. 用于生成放行目的分析数据的化验室设备缺乏接触权限控制。例如，化验室共用用户名和密码，所有用户都具有管理员权限，允许他们删除或修改HPLC和GC仪器中的文件。你们没有机制来方便追踪修改、调整或改动计算化系统生成的数据。 5. Your firm failed toestablish laboratory controls that include scientifically sound and appropriatespecifications, standards, sampling plans, and test procedures designed toassure that components, drug product containers, closures, in-processmaterials, labeling, and drug products conform to appropriate standards ofidentity, strength, quality, and purity (21 CFR 211.160(b)). 你们公司未能建立化验室控制来包括科学合理和恰当的规范、标准、取样计划和检测方法，设计用以确保成分、药品容器、密闭器、中间体、标签和药品符合恰当的鉴定、含量、质量和纯度标准(21 CFR211.160(b))。 Our investigator found thatyou failed to test incoming active pharmaceutical ingredients used tomanufacture finished products for the United States using the U.S. Pharmacopeia(USP). Your specifications allow a higher level of impurities, such as (b)(4)and (b)(4), than the limits established by USP. 我们的调查人员发现你们未使用USP检测用于生产销往美国的制剂成品生产的进厂活性药用成分。你们的质量标准允许使用比USP中所设定限度更高水平的杂质，例如XX和XX。 C GMP Consultant Recommended CGMP顾问建议 Based upon the nature of theviolations we identified at your firm, we strongly recommend engaging aconsultant qualified as set forth in 21 CFR 211.34 to assist your firm inmeeting CGMP requirements. 依据我们在你们公司发现的违规情况，我们强烈建议你们使用一位符合21CFR211.34要求的顾问来协助你们公司符合CGMP要求。 Your use of a consultant doesnot relieve your firm’s obligation to comply with CGMP. Your firm’s executivemanagement remains responsible for fully resolving all deficiencies andensuring ongoing CGMP compliance. 你们使用顾问并不解除你们公司符合CGMP的义务。你们公司的高级管理层仍负有义务全面解决所有缺陷，确保持续CGMP符合性。
| 
|手机版|蒲公英|ouryao|蒲公英
( 京ICP备14042168号-1 ) 增值电信业务经营许可证编号：京B2-20243455 互联网药品信息服务资格证书编号：(京)-非经营性-2024-0033
发表于 2018-12-4 21:50:19
置顶卡
变色卡