WHO生产、试验和检测组织关于COVID-19期间受到限制的常见问题.pdf

WHO NOTICE TO STAKEHOLDERS 20200505 WHO生产、试验和检测组织关于 COVID-19 期间受到限制的常见问题 20200505 译文仅供参考 翻译：JULIA 页 1/13 NOTICE TO STAKEHOLDERS 干系人须知干系人须知 Frequently Asked Questions By The Manufacturing,Trial And Testing Organizations In Connection With Some Of Their Constraints Faced During The Covid-19 生产、试验和检测组织关于生产、试验和检测组织关于 COVID-19 期间受到限制的期间受到限制的常见问题常见问题 WHO NOTICE TO STAKEHOLDERS 20200505 WHO生产、试验和检测组织关于 COVID-19 期间受到限制的常见问题 20200505 译文仅供参考 翻译：JULIA 页 2/13 Table of contents 目录目录 NOTICE TO STAKEHOLDERS 1 干系人须知 1 INTRODUCTION AND BACKGROUND 3 1.QUESTIONS RELATED TO INSPECTIONS 检查相关问题 3 2.QUESTIONS RELATED TO QUALITY MANAGEMENT SYSTEMS(QMS)关于质量管理体系（QMS）的问题 5 3.QUESTIONS RELATED TO PERSONNEL 关于人员的问题 7 4.QUESTIONS RELATED TO FACILITIES AND EQUIPMENT 关于设施与设备的问题 8 5.QUESTIONS RELATED TO MATERIAL 关于物料的问题 9 6.QUESTIONS RELATED TO PRODUCTION 关于生产的问题 10 7.QUESTIONS RELATED TO QUALITY CONTROL LABORATORIES(MANUFACTURERS,NATIONAL AND PRIVATE LABS)关于质量控制实验室（生产商、国家和私人实验室）的问题 10 REFERENCES 参考文献 13 USEFUL LINKS RELATED TO COVID-19 与 COVID-19 有关的实用链接 13 WHO NOTICE TO STAKEHOLDERS 20200505 WHO生产、试验和检测组织关于 COVID-19 期间受到限制的常见问题 20200505 译文仅供参考 翻译：JULIA 页 3/13 INTRODUCTION AND BACKGROUND 介绍和背景介绍和背景 On 30 January 2020,WHO Director-General,Dr Tedros Ghebreyesus declared that the outbreak of COVID-19 caused by the 2019 novel coronavirus(SARS-CoV-2)had constituted a Public Health Emergency of International Concern.Since then many countries have implemented measures to combat the spread of the disease,including but not limited to travel restrictions lockdown,quarantine and social distancing.2020 年 1 月 30 日，WHO 总干事谭德塞宣布 2019 新冠病毒（SARS-CoV-2）导致的 COVID-19 构成全球关注的公共卫生紧急事件。其后许多国家已采取措施防止疾病蔓延，其中包括但不仅限于旅行限制、隔离和社交疏离。As a result,manufacturers of active pharmaceutical ingredients(APIs),finished pharmaceutical products(FPPs),vaccines,medical devices including in-vitro diagnostics(IVDs),vector control products,quality control laboratories and contract research organizations(CROs)of WHO Prequalified Products are facing several challenges during this COVID-19 pandemic.In particular,some of them may be unable to fully meet their usual responsibilities of following Good Manufacturing Practices(GMP),Good Practice for Quality Control Laboratories(GPPQCL),Good Practice for Pharmaceutical Microbiology Laboratories(GPPML)Good Clinical Practices(GCP),Good Laboratory Practices(GLP)and Quality Management System(QMS)requirements respectively.由于上述原因，在 COVID-19 期间，原料药（API）、制剂（FPP）、疫苗、医疗器械，包括体外诊断试剂（IVD）、病媒控制产品、质量控制实验室和 WHO 预认证产品的合同研究组织（CRO）面临几大挑战。尤其是这些组织中有些可能无法全面履行各自遵守优良生产规范（GMP）、优良质量控制实验室规范（GPPQCL）、优良药品微生物实验室规范（GPPML）、优良临床规范（GCP）、优良实验室规范（GLP）和质量管理体系（QMS）要求的日常职责。This document was developed by WHO Prequalification Unit-Inspection Team(PQT/INS)with input from the Norms and Standards Pharmaceuticals(NSP),Health Products Policy and Standards Department,WHO.It provides basic guidance to manufacturers/laboratories/contract research organizations(herein after referred to as organizations),on regulatory expectations and flexibility during the COVID-19 pandemic in the form of questions and answers.It is underlined that the pandemic is affecting countries at different levels and the progress of the pandemic in each country may be at different stage;hence national measures and guidance should also be considered.The definitive aim is to ensure the quality,safety,efficacy and continuity in the supply of products and services in order to attain a high level of public health.The document will be updated to address new questions and to include further information for organizations to the evolution of the pandemic.It will remain valid until further notice.本文件由 WHO预认证部门-检查组（PQT/INS）制订，结合了标准药品（NSP）、卫生产品政策和标准部门、WHO 的意见。本文以问答方式为生产商/实验室/合同研究组织（以下称组织）提供 COVID-19 期间关于监管要求和灵活性的基本指南。要强调的是疫情影响各国程度不同，每个国家可能处于不同的抗疫阶段，因此还要考虑国家措施和指南。最终目的是确保产品和服务的质量、安全性、有效性和持续性，以维护高水平的公共卫生。本文将随疫情变化进行更新以回答新问题，包括更多信息。没有进一步通知前本文保持有效。1.QUESTIONS RELATED TO INSPECTIONS 检查相关问题检查相关问题 1.1.Would WHO PQT/INS consider waiving or postponing a routine site inspection for manufacturing,trial and testing organizations which have been inspected by WHO PQT/INS?WHO PQT/INS 是否会考虑豁免或推迟对是否会考虑豁免或推迟对已接受过已接受过 WHO PQT/INS 检查的检查的生产、试验和检测生产、试验和检测组织的常规检查？组织的常规检查？WHO NOTICE TO STAKEHOLDERS 20200505 WHO生产、试验和检测组织关于 COVID-19 期间受到限制的常见问题 20200505 译文仅供参考 翻译：JULIA 页 4/13 Yes,WHO PQT/INS may consider waiving or postponing an onsite inspection based on an initial risk assessment provided a successful WHO PQ inspection was performed in the past.In lieu of an onsite inspection,WHO may consider carrying out a desk assessment.The organizations would be contacted by WHO PQT/INS and requested to provide further information,where necessary.WHO PQT/INS will inform the organizations on the compliance outcome.If the desk assessment cannot adequately fulfil the purpose and requirement of the inspection,an onsite inspection will need to be performed when travel restrictions are lifted.是的。如果该现场过去曾经顺利通过 WHO PQ现场检查，则 WHO PQT/INS 会考虑根据初步风险评估的结果豁免或推迟现场检查。WHO可能会考虑使用远程评估来取代现场检查。WHO PQT/IN 会联系受检单位，要求其提供更多资料（必要时）。WHO PQT/INS 会将合规判定结果通知受检单位。如果远程评估无法满足检查的目的和要求，则需要在旅行限制解除时进行现场检查。1.2.Would WHO PQT/INS consider“waiving an onsite inspection”,for new products under prequalification,of organizations already inspected by WHO PQT/INS?WHO PQT/INS是否会考虑是否会考虑对曾接受过对曾接受过 WHO PQT/INS 现场检查的预认证新药品现场检查的预认证新药品“豁免现场检查”“豁免现场检查”？Yes,WHO PQT/INS may consider waiving an onsite inspection based on an initial risk assessment provided a successful WHO PQ inspection has been performed.In lieu of an onsite inspection,WHO may consider carrying out a desk assessment.The organizations would be contacted by WHO PQT/INS and requested to provide further information,where necessary.WHO PQT/INS will inform the organization on the compliance outcome.If the desk assessment cannot adequately fulfil the purpose and requirement of the inspection,an onsite inspection will need to be performed when travel restrictions are lifted.是的。如果该现场过去曾经顺利通过 WHO PQ现场检查，WHO PQT/INS 可能会考虑根据初步风险评估的结果豁免现场检查。如果远程评估无法满足检查的目的和要求，则需要在旅行限制解除时进行现场检查。1.3.Would WHO PQT/INS consider waiving an onsite inspection of a new organization(addition of a new manufacturing site)for an already prequalified product?WHO PQT/INS 是是否会考虑豁免一个已通过预认证的药品的新组织的现场检查（增加一个新的生产场所）？否会考虑豁免一个已通过预认证的药品的新组织的现场检查（增加一个新的生产场所）？Yes,WHO PQT/INS may consider waiving an onsite inspection based on an initial risk assessment provided a successful inspection has been performed by another regulatory body.In lieu of onsite inspections,WHO may consider carrying out a desk assessment.The organizations would be contacted by WHO PQT/INS and requested to provide further information,where necessary.WHO PQT/INS will inform the organization on compliance outcome.If the desk assessment cannot adequately fulfil the purpose and requirement of the inspection,an onsite inspection will need to be performed when travel restrictions are lifted.是的，如果该现场过去曾经顺利通过另一药监机构的现场检查，WHO PQT/INS 会考虑根据初步风险评估结果豁免现场检查。WHO可能会考虑进行远程评估。WHO PQT/IN 会联系受检单位，要求其提供更多资料（必要时）。WHO PQT/INS 会将合规判定结果通知受检单位。如果远程评估无法满足检查的目的和要求，则需要在旅行限制解除时进行现场检查。1.4.Would WHO PQT/INS consider waiving an onsite inspection for a new organization relating to a new product under assessment?WHO PQT/INS 是否会考虑豁免一个新组织正在是否会考虑豁免一个新组织正在审评的新产品的现场检查？审评的新产品的现场检查？Yes,WHO PQT/INS may consider waiving an onsite inspection on a case by case basis for high priority medicines,vaccines,medical devices including IVDs,vector control products and related organizations.In lieu of onsite inspections,WHO may consider carrying out a desk assessment.The organizations would be contacted by WHO PQT/INS and requested to provide further information,WHO NOTICE TO STAKEHOLDERS 20200505 WHO生产、试验和检测组织关于 COVID-19 期间受到限制的常见问题 20200505 译文仅供参考 翻译：JULIA 页 5/13 where necessary.WHO PQT/INS will inform the organization on the compliance outcome.If the desk assessment cannot adequately fulfil the purpose and requirement of the inspection,an onsite inspection will need to be performed when travel restrictions are lifted.是的，WHO/PQT/INS 会根据各案考虑豁免优先药品、疫苗、医疗器械包括 IVD、向量控制产品和相关组织的现场检查。WHO可能会考虑使用远程评估来取代现场检查。WHO PQT/IN 会联系受检单位，要求其提供更多资料（必要时）。WHO PQT/INS 会将合规判定结果通知受检单位。如果远程评估无法满足检查的目的和要求，则需要在旅行限制解除时进行现场检查。1.5.Would WHO PQT/INS consider waiving an onsite inspection of a Quality Control Laboratory(QCL)?WHO PQT/INS 是否会考虑豁免是否会考虑豁免 QC实验室（实验室（QCL）的现场检查？）的现场检查？Although inspection of QCLs is not considered a priority during the COVID-19 pandemic,WHO PQT/INS may consider postponing the inspection on a case by case basis.In lieu of an onsite inspection,WHO may consider carrying out a desk assessment.The laboratory would be contacted by WHO PQT/INS and requested to provide further information,where necessary.WHO PQT/INS will inform the organization on the compliance outcome.If the desk assessment cannot adequately fulfil the purpose and requirement of the inspection,an onsite inspection will need to be performed when travel restrictions are lifted.虽然 QCL的检查在 COVID-19疫情期间并不会作为优先项目，但 WHO PQT/INS 可能会考虑根据各案推迟检查。WHO可能会考虑使用远程评估来取代现场检查。WHO PQT/IN 会联系受检单位，要求其提供更多资料（必要时）。WHO PQT/INS 会将合规判定结果通知受检单位。如果远程评估无法满足检查的目的和要求，则需要在旅行限制解除时进行现场检查。1.6.Would WHO PQT/INS consider a delay in implementation of corrective and preventive actions(CAPA)resulting from an inspection that took place before or during the Covid-19 pandemic?WHO PQT/INS 是否会考虑是否会考虑在在 COVID-19疫情之前或期间的现场检查疫情之前或期间的现场检查导致的导致的CAPA 的的推迟实施？推迟实施？It is expected that CAPA corresponding to WHO PQ inspections conducted before or during the COVID-19 outbreak are submitted within the set deadlines.However,if justifiable,the organization may contact the respective inspection team and request for an extension of the deadline for CAPA submission.我们期望组织在设定的时间限内提交 COVID-19 之前或期间 WHO PQ 现场检查相应的 CAPA。但是如果有合理原因，组织可联系相关检查组，申请延长 CAPA 提交期限。1.7.Would WHO PQT/INS encourage a more structured meeting to discuss pending inspection issues with organizations,via suitable online communication tools?WHO PQT/INS是否鼓励召开更有建设性的会议，是否鼓励召开更有建设性的会议，与组织通过适当的在线交流与组织通过适当的在线交流工具讨论未决的检查问题？工具讨论未决的检查问题？Yes,WHO PQT/INS would welcome suitable online communication tools meetings to discuss pending inspection issues provided the concerned organization provides in advance an agenda with the topics for discussion and considering availability of inspection team members.是的，如果相关组织提前提交一份会议内容安排，说明要讨论的主题，在检查团队成员有时间情况下，WHO PQT/INS 欢迎使用适当的在线交流工具召开会议，讨论未决的检查问题。2.QUESTIONS RELATED TO QUALITY MANAGEMENT SYSTEMS(QMS)关于质量管理体系（关于质量管理体系（QMS）的问题）的问题 2.1.What are the regulatory expectations in terms of applying QMS principles during the COVID-19 pandemic?在在 COVID-19期间，关于期间，关于 QMS 原则应用原则应用方面方面有何有何监管期望？监管期望？It is acknowledged that the COVID-19 pandemic has a significant impact on people and businesses around the world and in many cases,re-prioritization of business activities is necessary in order WHO NOTICE TO STAKEHOLDERS 20200505 WHO生产、试验和检测组织关于 COVID-19 期间受到限制的常见问题 20200505 译文仅供参考 翻译：JULIA 页 6/13 to continue operations.Business continuity and disaster plans should be deployed,where applicable.The definitive aim should be to ensure the quality,safety,efficacy and continuity in the supply of products and services to meet a high level of public health and protect human lives.我们了解 COVID-19 疫情对全球人民和商业都有着重大影响。很多组织需要重新调整业务活动的优先度，以保持经营的持续性。适用时，应使用业务持续性和灾难计划。确保产品和服务供应的质量、安全性、有效性和持续性，满足高水平的公众健康要求，保护大众生命是最终目标。Top/senior management has the responsibility of ensuring an effective QMS is in place,is adequately resourced,and that roles,responsibilities,and authorities are defined,communicated and implemented throughout the organization.高级管理层有义务确保具备高效的 QMS，提供足够的资源，明确角色、职责和权力，并在组织内沟通和实施。It is expected that organizations located in countries where the COVID-19 pandemic does not have a significant impact and create constraints on everyday operations,operate under the implemented QMS,as usual.For organizations located in countries where the COVID-19 pandemic has led to significant disruptions in everyday life and operations,it is expected that top/senior management with the assistance of expert personnel review their QMS,using risk management principles in order to identify hazards,estimate the risk associated with the identified hazards,compare the identified and analysed risks against established criteria,decide to reduce and/or accept risks,share information about the risks and risk management plan with concerned personnel and finally review and monitor the output of the risk management process.It is expected that all key operations and processes are included in the risk management process to protect human lives and public health.Detailed records of the application of risk management principles should be maintained.如果组织位于受 COVID-19 疫情影响不严重，对日常运作没有形成限制的国家，应按常规执行 QMS。如果组织位于日常生活和运转受 COVID-19疫情严重破坏的国家，高级管理层在专家协助下审核其 QMS，使用风险管理原则识别危害，评估所识别出的危害有关的风险，将所识别和分析的风险与既定标准进行比较，决定是否需要降低和/或接受风险，与相关人员分享风险和风险管理计划的资料，最后审核并监控风险管理过程的结果。要求将所有关键操作和流程均包括在风险管理流程中，保护人员生命和公众健康。应保存风险管理原则应用的详细记录。Following the implementation of risk management principles,it may be necessary to adjust some processes and operations in order to continue operating under the QMS,establish new procedures and/or revise existing ones.These changes should be appropriately justified,assessed and documented using the existing change management system.If departures from the QMS principles and established procedures and processes are unavoidable during the COVID-19 pandemic,then the organization has to justify and evaluate these deviations and follow the deviation/non-conformance procedure.在实施了风险管理原则之后，可能有必要调整一些流程和操作，以继续按 QMS 运作，建立新程序和/或修订现有程序。应使用现有变更管理系统对这些变化进行恰当论证、评估和记录。如果在 COVID-19 期间无法避免偏离 QMS 原则和既定的程序与流程，则组织必须说明理由，评估这些偏差并遵守偏差/不符合程序。A plan for transition back to the normal state should also be established based on local/national/international recommendations considering risk management principles in order to facilitate return to the routine operations and activities after the pandemic state is lifted.还应根据当地/国家/国际建议，同时考虑风险管理原则制订重回正常状态的过渡计划，以便在WHO NOTICE TO STAKEHOLDERS 20200505 WHO生产、试验和检测组织关于 COVID-19 期间受到限制的常见问题 20200505 译文仅供参考 翻译：JULIA 页 7/13 疫情结束后回到常规操作和活动。3.QUESTIONS RELATED TO PERSONNEL 关于人员的问题关于人员的问题 3.1.What should personnel do to ensure compliance with QMS principles and regulatory standards during the COVID-19 pandemic?COVID-19期间，期间，为确保符合为确保符合 QMS 原则和注册原则和注册标准，标准，人员要如何做？人员要如何做？Top/senior management is responsible for identifying key operations to be maintained during the pandemic and personnel to work on/off-site based on risk management principles taking into account national regulations,guidance and measures.疫情期间，高级管理人员要负责基于风险管理原则，同时考虑国家法规、指南和措施，识别需要维护的关键操作，以及哪些人员要在现场工作。Selection of key operations and personnel should be justified and documented.Operations that could be performed remotely without compromising the QMS principles,should be encouraged.Consideration should be given to prevent the spread of the virus within the organization by limiting the number of personnel in the premises,where appropriate and by applying suitable organizational measures which should be justified,documented and monitored.More