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您的位置:首页 >> 资讯 >> 企业新闻 >> FDA警告信:湖北丹江口丹澳药业有限公司

FDA警告信:湖北丹江口丹澳药业有限公司

https://www.cphi.cn   2017-11-24 16:59 来源:转载

近日,FDA官网发布了对湖北丹江口丹澳药业有限公司的警告信,FDA于2017-07-31~08-04对其进行了检查,发现其原料药存在违反CGMP的行为。

       近日,FDA官网发布了对湖北丹江口丹澳药业有限公司的警告信,FDA于2017-07-31~08-04对其进行了检查,发现其原料药存在违反CGMP的行为。

       1. Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes.

       未能证实生产工艺可以重复生产出符合其既定质量标准的原料药。

       You did not validate the processes used to manufacture numerous batches of (b)(4) API prior to commercial distribution. You did not perform process qualification studies and lacked an ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality. You provided our investigator with a validation protocol that was approved on May 22, 2017, and the subsequent validation report that was approved on July 25, 2017, shortly before we inspected your facility.

       在商业销售之前,你们没有验证用于生产XX原料药的工艺。你们没有进行工艺确认研究和缺乏一个用于监测工艺控制状态的持续计划来确保稳定的生产操作和一致的药品质量。你们向我们的检查员提供了一份于2017年5月22日批准的验证方案,以及于2017年7月25日批准的它的验证报告,就在我们检查你们工厂前不久啊。

       Your batch records also lacked defined process parameters that you identified as critical for the manufacture of (b)(4) API such as blending (b)(4) and (b)(4).

       你们的批记录也没有定义好你们所识别的作为生产该原料药的关键工艺参数,例如混合XX和XX。

       Your firm does not have an adequate ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality. See FDA’s guidance document, Process Validation: General Principles and Practices, for general principles and elements of process validation at http://www.fda.gov/downloads/Drugs/.../Guidances/UCM070336.pdf.

       贵公司没有一个充分的用于监测工艺受控状态的持续计划来确保稳定的生产操作和一致的药品质量。有关工艺验证的一般原则和要素参见FDA指导文件——工艺验证:一般原则和规范:http://www.fda.gov/downloads/Drugs/.../Guidances/UCM070336.pdf。

       2. Failure of your quality unit to approve changes that potentially impact API quality.

       你们的质量部门未能执行其批准对原料药质量具备潜在影响的变更的职能。

       You failed to follow your change management program. Our investigator found numerous changes that were not adequately documented, and implemented without quality unit evaluation and approval per your procedure, Change Control. These changes included, but were not limited to, product specifications, test methods, analytical equipment, and cleaning procedures for the manufacturing of (b)(4) API. An effective change management program is essential to ensure adequate quality unit oversight of changes that may impact the quality of your (b)(4) API.

       你们未能遵循你们的变更管理程序。我们的检查员发现很多变更没有充分的记录,并且实施也没有按照变更控制规程得到质量部门的评价和批准。这些变更包括但不限于:XX原料药的质量标准,检验方法,检验设备和清洁程序。一个有效的变更管理程序对于确保质量部门充分监管可能影响产品质量的变更是必不可少的。

       FDA considers the expectations outlined in ICH Q7 in determining whether API are manufactured in conformance with CGMP. See FDA’s guidance document, Q7 Good Manufacturing Pracitce Guidance for Active Pharmaceutical Ingredients, for guidance regarding CGMP for the manufacture of API, at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073497.pdf. Specifically, refer to section XIII, Change Control.

       FDA考虑ICH Q7中罗列的期望作为判断原料药其生产是否符合CGMP的标准。关于原料药生产CGMP指南参见FDA指导文件——Q7活性药用成分良好生产规范指南

       3. Failure to ensure that all test procedures are scientifically sound and appropriate to ensure that your API conform to established standards of quality and purity.

       未能确保所有检验程序科学合理并适于确保你们的原料药符合既定含量和纯度标准。

       You failed to establish adequate test procedures. For example, your analyst manually integrated a high performance liquid chromatography test for (b)(4) API despite the fact that the chromatogram lacked peak resolution. When a chromatogram lacks peak resolution, detailed methods and appropriate oversight are essential to ensure test results, considered by the quality unit in batch release decisions, are scientifically valid. You lacked an approved protocol for manual integration or quality oversight of the practice.

       你们未能建立充分的检验程序。例如,你们的检验人员对XX原料药进行高效液相检验时使用手动积分,尽管此时该色谱缺乏峰分辨率。当一个色谱缺乏峰分辨率,需要详细的方法和充分的监管以确保检验结果科学有效。你们缺乏一份对手动积分的方案,也没有对该行为进行质量管控。

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