Resuming Normal Drug andBiologics Manufacturing During the COVID-19 Public Health Emergency
Guidance for Industry
I. Introduction 概述
II. Background 背景
III. Recommendations 建议
A. Addressing Deviations From Established CGMP Activities 解决CGMP活动偏差
B. Risk Management and Other Important Elements of a Plan To ResumeNormal Drug Manufacturing 风险管理和恢复正常药品生产的其它重要因素
C. Prioritizing Activities To Resume Normal Drug Manufacturing 恢复正常药品生产的优先工作
IV. Additional Resources 其它资源
I. Introduction 概述
FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.
FDA在保护美国免受诸如传染性冠状病毒病2019（COVID-19）等新兴传染病的威胁方面发挥着关键作用。FDA致力于提供及时的指导，以支持疫情应对工作。
FDA is issuing this guidance to help drug and biological product manufacturers during the COVID-19 public health emergency plan and prioritize current good manufacturing practice (CGMP) activities as they transition from operations impacted by the public health emergency to normal manufacturing operations. This guidance describes how to evaluate and prioritize the remediation of CGMP activities that were necessarily delayed, reduced, or otherwise modified during the public health emergency in order to maintain production and the drug supply.
FDA发布此指南意在COVID-19公共卫生应急计划期间帮助药品和生物制品生产商，并优先考虑企业从受影响状态过度到正常生产运作期间的CGMP活动。本指南介绍了如何评估和优先处理在公共卫生紧急情况下必须延迟、减少或以其他方式修改的CGMP活动，以维持生产和药品供应。
Except as noted in thisguidance, this policy is intended to remain in effect only for the duration ofthe public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).
除另有说明外，本政策仅在由HHS于2020年1月31日宣布并于1月27日生效的COVID-19公共卫生紧急事件期间有效，包括HHS秘书处根据《公共卫生服务法》（PHS法案）（42 USC 247d（a）（2））第319（a）（2）节进行的任何延期。
Given this public health emergency, and as discussed in the Notice in the Federal Register of March 25,2020 (85 FR 16949), titled “Process for Making Available Guidance Documents Related to Coronavirus Disease 2019,” available at https://www.govinfo.gov/content/pkg/FR- 2020-03-25/pdf/2020-06222.pdf, this guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.
鉴于此次突发公共卫生事件，如2020年3月25日联邦公报（85 FR 16949）中题为“提供与2019年冠状病毒病相关的指导文件的过程”的公告所讨论，由于FDA已确定事先公开参与该指南是不可行或不适当的，因此本指南的实施无需事先征询公众意见（参见《联邦食品，药品和化妆品法》（FD＆C法）第701（h）（1）（C）节和21 CFR 10.115（g）（2）。本指南将立即执行，但仍需根据FDA的优良指南规范接收建议。
In general, FDA’s guidancedocuments, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
通常，FDA的指导文件（包括本指南）并不构成法律强制义务。相反，指南描述了FDA当前对某个主题的想法，仅应被视为建议，引用了特定的监管或法规要求者除外。在FDA指南中使用“应”一词的意思是建议或推荐某事，但非强制。
III. Recommendations 建议
Drug manufacturers should assess the impact of the COVID-19 public health emergency on CGMP activities that were necessarily delayed, reduced, or otherwise modified in order to maintain production and the drug supply, and they should identify necessary remediations that ensure drug quality while endeavoring to return to normal manufacturing operations. FDA recognizes that in some cases, remediation activities that a manufacturer started during the public health emergency may not be completed until after the duration of the public health emergency. In such cases, the manufacturer should continue to follow the recommendations in this guidance with respect to such activities after termination of the public health emergency.
药品生产商应评估COVID-19公共卫生突发事件对CGMP活动的影响。为了维持生产和药品供应，这些活动被延迟、减少或以其他方式进行了修改。在努力恢复正常生产操作时，药品生产商应识别出必要的补救措施，确保药品质量。FDA认识到，在某些情况下，生产商在公共卫生突发事件期间开始的补救活动可能要等到公共卫生突发事件发生之后才能完成。在这种情况下，生产商应在公共卫生突发事件终止后继续遵循本指南中有关此类活动的建议。
If a drug manufacturer departed from established CGMP activities impacted by the COVID-19 public health emergency, the drug manufacturer should identify these deviations and any necessary remediation actions (see section III(A) below). The drug manufacturer should evaluate these actions as part of their risk management approach (see section III(B)). The results of the evaluation will help the drug manufacturer prioritize resumption activities (see section III(C)).
如果药品生产商受COVID-19公共卫生突发事件影响偏离了既定CGMP活动，则药品生产商应确定这些偏差和任何必要的补救措施（见第III（A）节）。药品生产商应评估这些措施，作为其风险管理方法的一部分（见第III（B）节）。评估结果将有助于药物生产商确定恢复活动的优先级别（见第III（C）节）。
