FDA警告信：MAH可以委派质量管理职责吗？可以不了解生产工艺吗？可以没有质量部门吗？

警告信缺陷翻译如下：

Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

贵公司的质量部门未能履行其责任，确保所生产的药品符合 CGMP，并符合既定的特性、含量、质量和纯度标准 （21 CFR 211.22）。

Your firm lacked an adequate quality unit (QU) to exercise appropriate procedures and controls to ensure your over-the counter (OTC) drug products are manufactured in compliance with CGMP.

贵公司缺乏足够的质量部门 （QU） 来执行适当的程序和控制措施，以确保药品的生产符合 CGMP。

Your firm utilized contract manufacturing organizations (CMOs) to perform manufacturing, processing, and packaging activities on your behalf. You received drug products from these CMOs and declared your firm as the manufacturer on import records. You delegated the QU responsibilities to your CMOs. For example, your agreement with(b)(4) states that you “sub-contract to (b)(4) the responsibility for ensuring that the products comply with all provision of the Regulations and Directive.”

贵公司使用合同制造组织 （CMO） 代表执行生产、加工和包装活动。你们从这些CMO 那里收到了药品，并在进口记录中将你们公司声明为制造商。你们将质量部门（QU）职责委派给CMO。例如，你们的协议规定你们“将确保药品符合法规和指令所有规定的责任分包给 （b）（4）”。

By delegating your QU responsibilities, your firm failed to have adequate oversight and procedures for your CMOs to ensure they operate in compliance with CGMPs. The records and information you provided demonstrate that your firm did not effectively exercise its responsibilities to oversee the quality of your CMO’s manufacturing operations. According to documentation provided by your firm, your CMO lacks an adequately designed aseptic processing room where ophthalmic drop products are manufactured and has not performed the following:

通过委派 QU 职责，贵公司未能为你们的 CMO 提供足够的监督和程序，以确保他们按照 CGMP 操作。你们提供的记录和信息表明，贵公司没有有效地履行监督CMO 生产操作质量的责任。根据贵公司提供的文件，贵公司的 CMO 缺乏充分设计的无菌生产车间来生产滴眼液，并且没有执行以下操作：

• Dynamic airflow visualization studies for aseptic processing

• 对无菌工艺的动态气流可视化研究

• (b)(4) effectiveness testing for benzalkonium chloride containing ophthalmic products

• 含苯扎氯铵的眼科产品的(b)(4)有效性检测

See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.

请参阅 FDA 指南：药品 CGMP 法规的质量体系方法，以帮助实施质量体系和风险管理方法，以符合21 CFR 第 210 和 211 部分的CGMP 法规。

In your response to this letter, provide:

回复此函，请提供：

A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:

全面的评估和补救计划，以确保你们的 QU 获得有效运行的权利和资源。评估还应包括但不限于：

• 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稳健和适当

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

• 对整个操作过程提供QU监督的规定，以评估对适当规范的符合情况

• 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完整和最终的审查

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

• 监督和批准调查并履行所有其他 QU 职责，以确保所有产品的特性、含量、质量和纯度

Also describe how top management supports quality assurance and reliable operations, including but not limited to timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of control.

此外，描述最高管理层如何支持质量保证和可靠运营，包括但不限于及时提供资源以主动解决新出现的生产/质量问题并确保持续的受控状态。