FDA警告信：质量部职责、生产负责放行、总经理批准SOP

4月7日，FDA对罗马尼亚Global Treat Srl的警告信中提及质量部门的职责问题，该公司产品检验记录由生产人员审核放行而非质量人员、SOP由总经理负责批准而非质量人员，此外，在客户合同中未描述该公司与客户之间在接收、记录、调查和报告投诉和严重不良事件方面的角色和责任。尽管该公司表示将在合同将指定客户是"授权代表"，但是，FDA表示，无论与客户签订何种协议，他们仍需对药品的质量负责。

缺陷翻译如下：

Your quality unit (QU) is not fully exercising its authority and/or responsibilities. Your QU failed to ensure that you have adequate procedures and did not provide adequate oversight of your manufacturing activities. For example:

你们的质量单位 （QU） 未能完全行使其权力和/或责任。你们的 QU 未能确保拥有适当的程序，并且未能对生产活动提供充分的监督。例如：

• Your QU failed to conduct a complete review of all production and control records, as well as laboratory notebooks before batch release. For example, production personnel instead of the QU received and reviewed final microbiological test results and signed off on the product data sheet, releasing the product for distribution.

• 你们的质量单位未能在批放行之前对所有生产和检验记录以及实验室记录本进行全面审查。例如，生产人员而不是QU接收并审阅了微生物测试的最终结果，并在记录上签名，将产品放行。

• Your General Manager, rather than your QU, reviews and approves procedures that are related to production and quality. The QU lacked final review and approval of documents and procedures that affect your firm’s drug product identity, strength, and quality.

• 你们的总经理（而不是质量单位）审核和批准与生产和质量相关的程序。对于影响你公司药品的鉴定、含量和质量的文件和程序，QU缺乏最终审核和批准。

• Your firm lacks written procedures delineating the roles and responsibilities between you and your client, HemoTreat LLC, regarding receipt, documentation, investigation, and reporting of complaints and serious adverse events.

• 贵公司缺乏书面程序，描述你公司与客户 HemoTreat LLC 之间在接收、记录、调查和报告投诉和严重不良事件方面的角色和责任。

In your response, you stated that procedures will specify that the Director of the QU gives the final approval for batch release and disposition. You also committed to reviewing your procedures regarding the receipt, documentation, investigation of complaints and adverse events and provide training.

在答复中，你们表示程序将指定 QU 总监对批放行和处置进行最终批准。你们还承诺审查有关接收、记录和调查投诉和不良事件的程序，并提供培训。

Your response is inadequate. Your response did not adequately address the impact of the lack of QU oversight and lack of review and approval of documents and procedures that affect your firm’s drug product identity, strength, and quality.

你们的回复是不充分的。你们的回复没有充分解决缺乏 QU 监督以及对影响药品鉴定、含量和质量的文件和程序缺乏审查和批准的影响。

Your response is also inadequate because of how complaints and adverse events are addressed. While you stated your contracts will specify that HemoTreat LLC is an “authorized representative”, your response lacked sufficient details about how HemoTreat LLC will receive, document, investigate, and report complaints and adverse events. Moreover, you, as the owner, are responsible for the quality of your drug products regardless of agreements in place with your client, HemoTreat LLC.

你们关于投诉和不良事件如何解决的回复也是不充分的。虽然你们表示你们的合同将指定 HemoTreat LLC 是"授权代表"，但你们的回复缺乏关于 HemoTreat LLC 将如何接收、记录、调查和报告投诉和不良事件的足够详细信息。此外，作为所有者，无论与客户 HemoTreat LLC 签订何种协议，你们对你们的药品质量负责。

In response to this letter, provide a comprehensive assessment with your planned corrective actions and preventive actions (CAPA) to ensure your QU is given the authority and resources to independently and effectively function. The assessment should also include, but not be limited to:

回复此函，提供全面的评估，以及计划采取的纠正措施和预防措施（CAPA），以确保你们的 QU 获得独立和有效运作的权力和资源。评估还应包括，但不限于：

• A complete assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation

• 全面评估在整个生产和实验室操作中使用的文件记录系统，以识别文件记录实践不足的地方。包括详细的 CAPA 计划，全面修复公司文件记录规范，确保在整个操作过程中保留可归属、清晰、完整、原始、准确、同步的记录。

• A determination of whether procedures used by your firm are robust and appropriate.

• 确定贵公司使用的程序是否健全且适当。

• Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.

• 在整个操作过程中进行QU监督的规定，以评估对适当规范的遵守情况。

• A complete and final review of each batch and its related information before the QU disposition decision.

• 在 QU 处置决定之前，对每个批次及其相关信息进行全面和最终审查。

• Oversight and approval of investigations and discharging of all other QU duties to ensure the identity, strength, quality, and purity of all products.

• 监督和批准调查和履行所有其他 QU 职责，以确保所有产品的鉴定、含量、质量和纯度。

       文章来源：法默康GMP咨询

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