FDA宣布两项旨在使药品质量计划现代化的举措

恨我不成钢

Posted on July 26, 2018 by FDA Voice

FDA之声于2018年7月26日发布

By: Janet Woodcock, M.D., and Michael Kopcha, Ph.D., R.Ph.

Patients expect and deserve high-quality drugs – this means consistently safe and effective medicines, free of defects and contamination. To satisfy these important expectations, the FDA strives to make sure that FDA-approved drugs are manufactured to meet quality standards to ensure that every dose is safe, effective, and capable of providing its intended benefit.

患者期望得到高质量的药物—这意味着药物始终能保持安全有效，没有缺陷和污染。为了满足患者的殷殷期望，FDA努力确保所批准药物的在生产上符合质量标准，从而保证每个剂量安全、有效并且能够提供预期的益处。

Quality metrics are used in a variety of industries to monitor the quality control systems and processes that ensure standards are met, and to identify opportunities for manufacturing improvements. For the pharmaceutical industry, the use of quality metrics offers potential benefits to patients, manufacturers, and the FDA – including the potential to better combat drug shortages.

在许多行业中，质量度量被用于监控质量控制系统和过程，以确保达到标准，并识别制造改进的机会。对于制药工业，使用质量度量为患者、制造商和FDA提供潜在的益处，包括更好地防止药物短缺的可能性。

With these benefits in mind, the FDA has announced two new voluntary programs – the Quality Metrics Feedback Program and the Quality Metrics Site Visit Program – in response to stakeholder requests for continued dialogue on quality metrics, and to provide methods for industry to engage and inform the FDA’s use of them in the future. The programs will also help drug manufacturers to gain a better understanding of how quality metrics are a common feature of quality culture, and support improvements in product and process quality.

考虑到这些好处，FDA已经宣布了两个新的自愿计划——质量度量反馈计划和质量度量试点访问计划——以响应利益相关者关于质量度量的持续对话的要求，并为行业提供方法，让他们参与并告知FDA在未来的使用。这些项目还将帮助药品制造商更好地理解质量度量是质量文化的一个共同特征，并支持改进产品和工艺质量。

Feedback from early adopters and manufacturers who implemented quality metrics programs to address manufacturing problems, as well as independent academic research supported by the FDA, indicates that a manufacturer’s overall quality program benefits from the use of quality metrics. Quality metrics, such as data on the rate at which manufactured lots have been rejected for failing to meet established standards, can help manufacturers monitor quality control systems and drive continuous improvement efforts. For the FDA, data on quality metrics can help us better assess risk when scheduling inspections. This has the potential of decreasing the frequency of surveillance inspections for lower-risk establishments and narrowing the focus of on-site inspections conducted.

来自早期采用者和制造商的反馈，他们实施了质量度量程序来解决制造问题，以及由FDA支持的独立学术研究，表明制造商的整体质量计划受益于质量度量的使用。质量标准，例如生产批次因未达到既定标准而被拒率的数据，可以帮助制造商监控质量控制系统并推动持续改进工作。对于FDA来说，质量度量的数据可以帮助我们在安排检查时更好地评估风险。这有可能减少对低风险设施的监督检查频率，并缩小现场检查的重点范围。

The proximal cause of many drug shortages are quality issues such as substandard manufacturing facilities or processes. Quality metrics can be useful in identifying situations in which a drug supply disruption may occur, which can help mitigate potential future drug shortages. This will help to reassure patients that quality medicines will be available when they need them.

许多药品短缺的直接原因是质量问题，如不合格的生产设备或工艺。质量度量可用于识别可能发生药物供应中断的情况，这有助于减轻未来潜在的药物短缺。这将有助于让患者放心，当他们需要高质量的药物时，他们将会得到。

§  The Quality Metrics Feedback Program solicits information from drug manufacturers and sponsors that have implemented and are currently using quality metrics programs. The FDA is encouraging applicants eligible for Type C meetings as well as abbreviated new drug application (ANDA) holders to submit meeting requests to the FDA to discuss quality metrics for specific products. As part of the feedback effort, the FDA is also beginning a pilot study to gain feedback from other types of establishments where these types of meetings are not applicable, such as active pharmaceutical ingredient suppliers, over-the-counter monograph product establishments, and contract manufacturing organizations (CMOs).

§  质量度量反馈计划从制药商和赞助商那里获得信息，这些产品已经实施并正在使用质量度量程序。FDA鼓励符合C类会议的申请人，以及简化的新药申请（ANDA）持有人向FDA提交会议请求，以讨论特定产品的质量标准。作为反馈工作的一部分，FDA还开始进行试验研究，以获得来自其他类型的机构的反馈，以下机构不适用这类型的会议，例如活性药物成分供应商、非处方专线产品机构和合同制造组织(CMOs)。

§  The purpose of the Quality Metrics Site Visit Program is to provide on-site, firsthand learning opportunities to the FDA staff involved in the development of the FDA Quality Metrics Program. The Site Visit Program also is intended to provide stakeholders with the opportunity to explain the advantages and challenges they’ve experienced when implementing and managing their quality metrics programs.

§  质量度量试点访问计划的目的是提供有FDA工作人员参与FDA质量度量项目的发展的现场,亲身学习机会。试点访问计划还旨在向利益相关方提供机会，说明他们在实施和管理其质量度量计划时所经历的优势和挑战。

The FDA’s new initiatives continue to enhance the focus of the conversation between the FDA and drug manufacturers to better understand – and make use of – quality metrics programs. We are confident these efforts will improve both the efficiency and the effectiveness of drug manufacturing, helping to assure a reliable and high-quality drug supply.

FDA的新举措将继续加强FDA和药品制造商之间的对话，以更好地理解和利用质量度量程序。我们相信，这些努力将提高药物生产的效率和效益，有助于确保可靠和高质量的药物供应。

胜利者

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PennyNie

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