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FDA announced theavailability of adraft guidance for industry, Quality Considerationsfor Continuous Manufacturing,which provides information regarding FDA’s current thinking on the qualityconsiderations for continuous manufacturing of small-molecule, solid oral drugproducts that are regulated by the Center for Drug Evaluation and Research(CDER), the agency announced in a Feb. 26, 2019 press release. The guidancedescribes several key quality considerations and provides recommendations forhow applicants should address these considerations in new drug applications(NDAs), abbreviated new drug applications (ANDAs), and supplemental NDAs andANDAs, for small-molecule, solid oral drug products that are produced via acontinuous manufacturing process. 药品评价和研究中心(CDER)在2019年2月26日的新闻稿中宣布，FDA颁布了有关连续生产中质量注意事项的一份工业指南草案，该指南提供了关于FDA在小分子口服固体药物连续生产质量问题上目前的思考。指南描述了几个关键的质量注意事项并且针对如何处理通过连续生产工艺生产的小分子口服固体药物在美国新药申请，仿制药申请以及补充申请方面的注意事项提供了建议。 FDA invites general commentsto the docket on the quality considerations described in the draft guidance,including comments on control strategy, facility, and process validationconsiderations for continuous manufacturing of small-molecule, solid oral drugproducts. In addition to comments on the guidance generally, FDA isrequesting comments and related supporting information on the following topics: FDA对指南草案中描述的质量注意事项的内容征求了一般性意见，包括连续生产小分子固体口服药物的控制策略、设施和工艺验证考虑事项的意见。除了对指南的一般意见外，FDA同时就以下主题征求了意见和相关支持信息:
FDA is seeking public commenton topics for potential inclusion in the final guidance or additional guidanceand any other alternative approaches. In addition to this guidance,pharmaceutical manufacturers with product-specific continuous manufacturingquestions may submit a proposal to the Emerging Technology Program. FDA正在就最终指南或附加指南以及任何其他替代方法中潜在结论的主题征求公众意见。除本指南外，具有特定产品连续生产问题的制药企业可向新兴技术项目提交建议。 In a Feb. 26, 2019 statement, FDA Commissioner Scott Gottlieb, MD, andJanet Woodcock, MD, director of CDER, described continuous manufacturing (CM)as “a key step towards promoting drug quality and improving the efficiency ofpharmaceutical manufacturing.” They noted that the draft guidance “will clarifythe FDA’s current thinking regarding innovative CM approaches and can helpresolve potential issues some companies have as they consider implementation,such as concerns that use of new CM technology might impact the time FDA takesto assess applications for new products and switching from a batch to CMprocess for existing products.” The guidance should advance implementation ofCM by explaining “what process and control strategy designs (includingequipment) are needed to meet regulatory considerations and how a CM platformtechnology can be used to manufacture multiple products, so that productdevelopers can have more certainty about the capital investments they need tomake. This can provide sponsors with more assurance about the costs of adoptingthese new methods and the payoffs they can anticipate from making theseinvestments,” said Gottlieb and Woodcock in the statement. 在2019年2月26日的一份声明中，FDA专员Scott Gottlieb医学博士和CDER主任Janet Woodcock医学博士将连续生产(CM)描述为“促进药品质量和提高药品生产效率的关键步骤。”他们指出，指南草案“将澄清FDA对创性新的连续生产方法目前的思考,并且能够帮助一些公司解决在执行过程中可能会面临的问题,比如使用新的连续生产技术可能会影响到FDA对新产品申请评估的时间以及将现有生产方式生产的产品切换到连续生产工艺的时间。”该指南应该通过解释这些问题推进连续生产的实施，如“需要什么样的过程和控制策略设计(包括设备)来满足监管方面的考虑，以及连续生产平台技术如何用于生产多种产品，以便产品开发人员能够对他们需要进行的资本投资有更多的确定性。”在采用这些新方法的成本以及他们能从这些投资中预期得到的回报方面，可以为赞助商提供更多的保证”Gottlieb and Woodcock在声明中说到。 They also pointed out thatFDA proposed development of a guidance on CM to the International Council forHarmonization of Technical Requirements for Pharmaceuticals for Human Use(ICH). The ICH assembly accepted the FDA’s proposal and set a goal of finalizingthe guidance by 2021. 他们还指出，FDA向国际人用药技术要求协调委员会(ICH)建议制定“连续生产”指南。ICH大会接受了FDA的建议，并设定了2021年完成指南定稿的目标。 Source: FDA 消息来源：FDA |
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