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[翻译交流] 2018/11/28 FDA警告信:韩国 Barox

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药徒
发表于 2018-12-7 11:00:32 | 显示全部楼层 |阅读模式

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During our inspection, our investigator observed specific violations including, but not limited to, the following:
在我们检查期间,我们的检察员观察到了不限于以下的违规项:
1.      Your firm failed to establish written responsibilities and procedures applicable to the quality control unit (21 CFR 211.22(d)).
贵公司未能建立适用于质量控制部门的书面责任和程序
Your firm relabels over-the-counter (OTC) drug products made for you by a contract manufacturer. You then distribute these drug products to the United States. You have no written documents describing roles and responsibilities of a Quality Control Unit (QCU). All of your employees, including those in the QCU, lack knowledge of CGMP requirements.
贵公司对合同制造商生产的OTC药进行了重新贴标签处理。然后贵司将这些产品分销到美国。贵司没有书面文件来描述质量控制部门的角色及职责。贵司所有的职员,包括质量控制部门,缺乏对CGMP要求的了解。
Your response states, "These procedures will be reviewed and approved by the quality unit as below," and the remainder of the document contained 21 CFR part 211 citations quoted verbatim. Your response failed to provide:
在贵司的回复中说道:“这些程序将由质量部门按照如下重新审核及审批” 。该文件的其余部分逐字引用了21 CF4R 211。
贵司的回复没有提供:

·      A detailed description of the responsibilities of your QCU. 对于质量控制部门角色职责的详细描述
·      Evidence that you have established appropriate written procedures for QCU functions. 质量控制部门建立起适当的书面程序的证明
·      Evidence that your personnel are appropriately trained to perform their assigned function. 人员经过适当的培训后具有岗位相应能力的证明


2.      Your firm failed to exercise strict control over labeling issued for use in drug product labeling operations (21 CFR 211.125(a)). 贵公司未能严格控制药品标识操作中使用的标签(21 CFR 211.125(a))

You have no procedures for relabeling operations, including issuance or reconciliation of labels. You relabel at least (b)(4) drug products, including (b)(4) for the U.S. market, without proper labeling controls to prevent labeling mix ups.
贵司没有重贴标签操作程序,包括标签的发放以及数量核对。贵司将至少xx批产品重贴了标签,包括供应到美国市场的xx,没有恰当的标签控制防止标签弄混。
Your response failed to provide written procedures for labeling operations performed at your facility. You failed to ensure that relabeling occurs under appropriate CGMP controls.
在贵司的回复函中没有提供贵司贴签操作的书面程序。您未能确保重贴标签操作是符合相应CGMP要求的。
3.      Your firm failed to establish and follow written procedures regarding storage and warehousing of drug products (21 CFR 211.142).
贵司未能建立以及遵守药品存储相应的书面程序
You have no procedures for storage and warehousing of drug products, including quarantine storage before release of drug products.
你们没有药品存储及入仓的程序,包括药品放行前的适当的隔离。
Your response failed to provide written procedures for storage and warehousing. Holding of drug products must be performed under appropriate CGMP controls.
在你们的回复中,没有提供药品存储及入仓的书面程序。药品的保存必须遵守相应CGMP要求。
CGMP consultant recommended
建议引入CGMP咨询师
Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34, to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance.
基于我们识别出的贵司的违规行为,我们强烈建议贵司雇佣符合21 CFR 211.34 第四部分资质的专家来帮助贵司保持CGMP合规。您使用顾问并不能免除您的公司遵守CGMP的义务。贵公司的执行管理层仍负责全面解决所有缺陷,并确保持续遵守CGMP。

Owner’s responsibilities 公司所有者职责
Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors, such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.
药品生产必须遵守CGMP。FDA认识到很多药品制造商跟许多独立合同商合作,例如原料药生产商,分析实验室,包装供应商,以及标签。但FDA将这些独立合同商认为是药品生产商的一部分。
You are responsible for the quality of drugs you produce, regardless of agreements in place with your contract facility. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act to ensure safety, identity, strength, quality, and purity. See FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements
你们应对所生产的药品质量负责,不能仅仅依靠跟合同商的协议来保证外包活动的合规性。您必须确保药品是按照FD&C法案第501(a)(2)(B)条生产的,以确保药品安全性、同一性、强度、质量和纯度。详见FDA指南:药品合同生产:质量。
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大师
发表于 2018-12-7 13:01:51 | 显示全部楼层
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药徒
发表于 2018-12-10 15:48:43 | 显示全部楼层
Thanks for sharing
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药神
发表于 2022-8-3 19:24:32 | 显示全部楼层
非常感谢分享
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