WHO发布质量体系、设备设施、QC实验室、生产、人员、物料应对新冠疫情指南！

验证师

原创 翻译组  制药经理人

近日，WHO发布了制造、试验和测试组织与COVID-19相关的问题解答文件，包含了药品制造、医疗器械、疫苗、质量控制实验室等机构在面对COVID-19疫情时需要解决的各类问题的解答：

与检查相关的问题
与质量管理体系(QMS)相关的问题
与人员相关的问题
与设施和设备相关的问题
与物料相关的问题
与生产相关的问题
QC实验室相关问题


全文翻译如下：





FREQUENTLY ASKED QUESTIONS BY THE MANUFACTURING, TRIAL AND TESTING ORGANIZATIONS IN CONNECTION WITH SOME OF THEIR CONSTRAINTS FACED DURING THE COVID-19 OUTBREAK
制造、试验和测试组织与COVID-19相关的问题解答



Tableof contents

目录

Introduction and background
介绍及背景
Questions related to inspections
与检查相关的问题
Questions related to quality managementsystems (QMS)
与质量管理体系(QMS)相关的问题
Questions related to personnel
与人员相关的问题
Questions related to facilities andequipment
与设施和设备相关的问题
Questions related to material
与物料相关的问题
Questions related to production
与生产相关的问题
Questions related to quality controllaboratories
QC实验室相关问题
References
参考资料


INTRODUCTION AND BACKGROUND
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TedrosGhebreyesus博士宣布，2019年新型冠状病毒(SARS-CoV-2)引发的新型冠状病毒肺炎疫情构成了国际关注的突发公共卫生事件。从那时起，许多国家已经采取措施来对抗这种疾病的传播，包括但不限于封锁旅行限制、隔离检疫和社会疏远。

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.
因此，药物活性成分、制剂、疫苗、包括体外诊断剂在内的医疗器械、病媒控制产品、质量控制实验室和合同研究机构在这场新型冠状病毒肺炎大流行期间面临着各种挑战。特别是，部分实验室可能无法完全履行其常规职责，即分别遵守良好制造规范（GMP）、质量控制实验室的良好规范(GPPQCL)、药物微生物实验室良好规范(GPPML)、良好临床试验规范（GLP）、和质量管理体系（QMS）的规定。

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预确认检查小组 (PQT/INS )根据WHO卫生产品政策和标准部的规范和标准药品(NSP)的意见编写。它以问答的形式为制造商/实验室/合同研究组织(以下简称组织)提供了关于新型冠状病毒肺炎流行期间的监管期望和灵活性的基本指导。需要强调的是，这一流行病正在影响不同级别的国家，每个国家的流行病进展可能处于不同阶段;因此，还应考虑国家措施和指导。其最终目标是确保产品和服务的质量、安全性、有效性和持续性，以实现高水平的公共卫生。将对该文件进行更新，以处理新的问题，并为各组织提供有关该大流行病演变的进一步资料。本文件保持有效，直至另行通知为止。


1. QUESTIONS RELATED TO INSPECTIONS
与检查相关的问题

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是否会考虑取消或延迟对已接受WHO PQT/INS检查的制造、试验和检验组织进行例行现场检查？

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，WHO PQT/INS将根据初步风险评估考虑取消或延迟现场检查，条件是过去曾成功进行过WHO PQ检查。WHO可能考虑进行案头评估以代替现场检查。WHO PQT/INS将与这些组织联系，并要求它们在必要时提供进一步的信息。WHO PQT/INS将向各组织通报符合性结果。如果案头评估不能充分满足检查的目的和要求，则需要在旅行限制取消时进行现场检查。

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是否考虑对已接受WHO PQT/INS检查的组织的新产品预确认“延迟现场检查”？

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，WHO PQT/INS将考虑在初步风险评估的基础上取消现场检查，条件是曾经接受成功的WHO PQ检查。WHO可考虑进行案头评估来代替现场检查。WHO PQT/INS将与这些组织联系，并要求它们在必要时提供进一步的信息。WHO PQT/INS将向组织通报符合性结果。如果案头评估不能充分满足检查的目的和要求，则需要在旅行限制取消时进行现场检查。

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是否会考虑对一个已经通过预确认的产品取消对一个新组织(增加一个新的生产场所)的现场检查？

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，WHO PQT/INS将考虑根据初步风险评估取消现场检查，条件是另一监管机构已成功进行了检查。WHO可以考虑进行案头评估代替现场检查。WHO PQT/INS将与这些组织联系，并要求它们在必要时提供进一步的信息。WHO PQT/INS将向组织通报符合性结果。如果案头评估不能充分满足检查的目的和要求，则需要在旅行限制取消时进行现场检查。

1.4. Would WHO PQT/INS consider waiving an onsite inspection for a new organization relating to a new product under assessment?
对于一个新的组织的新的在审产品，WHO PQT/INS是否会考虑取消现场检查？

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, 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将考虑根据具体情况，对高优先级的药物、疫苗、医疗器械包括IVDs、病媒控制产品和相关组织免除现场检查。WHO将考虑进行案头评估代替现场视察。WHO PQT/INS将与这些组织联系，并要求它们在必要时提供进一步的信息。WHO PQT/INS将向组织通报符合性结果。如果案头评估不能充分满足检查的目的和要求，则需要在旅行限制取消时进行现场检查。

1.5. Would WHO PQT/INS consider waiving an onsite inspection of a Quality Control Laboratory (QCL)?
WHO PQT/INS是否考虑取消对质量控制实验室(QCL)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.
虽然在新型冠状病毒肺炎流感大流行期间，对QCLs的检查并不被认为是优先事项，但WHO PQT/INS可能会考虑根据实际情况推迟检查。WHO可考虑进行案头评估代替现场检查。WHO PQT/INS将与该实验室联系，并要求在必要时提供进一步的信息。WHO PQT/INS将向组织通报符合性结果。如果案头评估不能充分满足检查的目的和要求，则需要在旅行限制取消时进行现场检查。

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?
对于在新型冠状病毒肺炎流感大流行之前或期间的检查缺陷，WHO PQT/INS会考虑延迟其纠正和预防措施(CAPA)的实施吗？

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.
新型冠状病毒肺炎疫情爆发之前或期间进行的WHO PQ检查的CAPA答复，需要在规定的期限内提交。但是，如果有正当理由，组织可以联系相应的检查小组，请求延长CAPA提交的期限。

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是否鼓励通过适当的在线交流工具，举行更有组织的会议，与各组织讨论悬而未决的检查问题？

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，如果有关组织事先提供一份议程，列出待讨论的议题，并考虑检查组成员的时间安排，WHO PQT/INS将欢迎举行适当的在线交流会议讨论悬而未决的检查问题。


2. QUESTIONS RELATED TO QUALITY MANAGEMENT SYSTEMS (QMS)
与质量管理体系有关的问题

2.1. What are the regulatory expectations in terms of applying QMS principles during the COVID-19 pandemic?
在COVID-19大流行期间应用质量管理体系原则的监管期望是什么？

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 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.
新型冠状病毒肺炎流行病对世界各地的人和企业有着严重影响，在许多情况下，为了继续运营，重新确定企业活动的优先次序是必要的。应酌情部署业务连续性和灾害计划。最终目标应该是确保产品和服务的质量、安全、有效性和持续性，以满足高水平的公共卫生和保护人的生命。

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.
高层/高级管理人员有责任确保有效的质量管理体系，配备有充足的资源，并确保角色、责任和权力在整个组织中得到明确、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.
位于新型冠状病毒肺炎疫情没有明显影响并对日常运作造成限制的国家的机构，应如往常一样在实施的质量管理体系下运作。对于位于新型冠状病毒肺炎流行病导致日常生活和业务严重中断的国家的组织，高层/高级管理人员应在专家人员的协助下审查其质量管理体系，利用风险管理原则来识别危害，估计与所识别危害相关的风险，将识别和分析的风险与既定标准进行比较，决定减少和/或接受风险，与相关人员分享有关风险和风险管理计划的信息，最后审查和监测风险管理过程的产出。所有关键业务和进程都应纳入风险管理进程，以保护人的生命和公共健康。应该保留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.
在实施风险管理原则后，可能需要调整一些流程和操作，以便继续在质量管理体系下运作，建立新的程序和/或修订现有的程序。这些变更应该使用现有的变更管理系统进行适当的理由说明、评估和记录。如果在新型冠状病毒肺炎流行期间不可避免地偏离质量管理体系的原则和既定的程序和过程，那么组织必须证明和评估这些偏离，并遵循偏离/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.
还应根据考虑到风险管理原则的地方/国家/国际建议，制定恢复正常状态的计划，以便在大流行状态解除后，恢复日常业务和活动。


3.  QUESTIONS RELATED TO PERSONNEL
人员相关问题

3.1. What should personnel do to ensure compliance with QMS principles and regulatory standards during the COVID-19 pandemic?
在新型冠状病毒肺炎流感大流行期间，人员应该如何确保遵守质量管理体系原则和监管标准？

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.
最高/高级管理层负责确定大流行期间需要维持的关键业务，并根据风险管理原则，在考虑到国家条例、指导和措施的情况下，确定人员在现场/场外开展工作。

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 specifically, measures to be considered include but not limited to:
关键操作和人员的选择应该有正当的理由并记录在案。应该鼓励在不损害质量管理体系原则的情况下远程执行的操作。应考虑防止病毒在组织内传播，办法是酌情限制房舍内的人员数目，并采取适当的组织措施，这些措施应有正当理由，记录在案，并加以监测。更具体地说，应考虑的措施包括但不限于:

Developing a contingency plan in case any employee or subject (relevant to CROs only) is tested positive for COVID-19.
制定一个应急计划，以防任何员工或物品(仅与CRO有关)检出新型冠状病毒肺炎阳性。
Providing remote training on extra hygiene measures and procedures.
提供关于额外卫生措施和程序的远程培训。
Encouraging personnel to stay home if sick, or if any member of their family is sick and to report to the organization’s physician or authorities for prompt identification and isolation.
鼓励员工在生病或其家庭成员生病时留在家中，并向该组织的医生或当局报告，以便及时进行检查和隔离。
Encouraging personnel to avoid public gatherings and using crowded public transport.
鼓励员工避免公众集会或使用拥挤的公共交通工具。
Implementing body temperature control before entry to the facilities.
在进入工厂前实施体温控制。
Implementing frequent hand washing with soap and water and the use of hand disinfectant, where appropriate.
实施频繁的洗手，使用肥皂和水，并在适当情况下使用手消毒剂。
Reminding personnel to avoid touching their eyes, nose, and mouth with unwashed hands.
提醒员工避免用未洗手的手触摸眼睛、鼻子和嘴巴。
Increasing physical distance between employees or limiting the number of employees in a specific room/area (e.g. personnel change rooms, canteen, clean areas).
增加员工之间的物理距离或限制特定房间/区域内的员工人数(如更衣室，食堂，洁净区)。
Avoiding face-to-face work area designs.
避免面对面的工作。
Using disposable personal protective equipment (e.g. masks, gloves, goggles, shoe coverings, coveralls, gowns) or reducing the duration of use of re-usable personal protective equipment.
使用一次性个人防护装备(例如口罩、手套、护目镜、鞋套、工作服)或缩短可重复使用的个人防护装备的使用时间。
Avoiding visitors or contractors entering the facilities during the pandemic, unless necessary and ensuring that extra hygiene measures are applied and visitors are observed from a safe distance during their visit.
除非有需要，应避免访客或承办商在大流行期间进入工厂，并确保在访问期间采取额外的卫生措施和在安全距离内观察访客。


4. QUESTIONS RELATED TO FACILITIES AND EQUIPMENT
与设施和设备有关的问题

4.1. How should facilities and equipment be maintained at suitable operational states during the COVID-19 pandemic?
4.1.在新型冠状病毒肺炎流感大流行期间，应如何维护设施和设备在适当的运行状态下？

In general, manufacturing facilities and equipment are expected to be cleaned and sanitized, where appropriate, according to established procedures. The organizations should review and evaluate the cleaning/disinfection agents and intervals and ensure that the cleaning frequency and methods provide sufficient protection when contamination is suspected or confirmed due to coronavirus. Where new cleaning agents or disinfectants are to be applied, consideration should be given to not adversely affect the product or service and the operations performed in the room/with the equipment.
一般来说，生产设施和设备应该被清洁和消毒，如果合适的话，按照既定的程序。各机构应检讨和评估清洁/消毒剂及时间间隔，并确保在怀疑或证实由冠状病毒引致污染时，清洁次数和方法能提供足够的保护。如使用新的清洁剂或消毒剂，应考虑不对产品或服务以及在该房间/设备上的操作产生不利影响。

In clean areas where Heating Ventilation and Air-conditioning (HVAC) systems are used, additional engineering controls (e.g. increased ventilation rates, use of physical barriers) should be evaluated and considered if there is a risk of coronavirus contamination. Similarly, close monitoring of cleanroom process controls such as air filtration, positive air pressure and air flow patterns to ensure proper function, should be assessed and implemented based on risk management principles.
在使用暖通空调系统的洁净区，如有冠状病毒污染的风险，应评估和考虑采取额外的工程控制措施(例如增加换气次数、使用物理屏障)。同样，应根据风险管理原则评估和实施密切监控洁净室过程控制，如空气过滤、正压和空气流动模式，以确保正确的功能。

Where facilities, systems, utilities and equipment need to be qualified, calibrated, verified and maintained, it is expected that the existing procedures are followed (see also Q&A 3.1). However, during the pandemic, it may not be possible for contractors to provide engineering, maintenance, qualification and calibration support. Risk assessments should be conducted on the suitability of facilities, systems, utilities and equipment beyond their calibration/maintenance due date and if used beyond their calibration/maintenance due date, the deviation/non-conformance procedure should be followed. If it is deemed necessary to maintain, qualify or calibrate equipment the following alternatives should be evaluated and applied and any additional measures as necessary with appropriate documented justification:
设施、系统、公用设施和设备的确认、校准、验证和维护，应遵循现有程序(另见问答3.1)。然而，在大流行期间，对于外包服务商，可能无法提供工程、维护、确认和校准支持。应对设施、系统、公用系统和设备在校准/维修有效期之后的适用性进行风险评估，如果在校准/维修有效期之后使用，则应遵循偏差/不符合程序。如果认为有必要对设备进行维护、确认或校准，则应评估和采用下列替代方式，并采取任何必要的额外措施，并提供适当的书面论证:

Send equipment off site for requalification, calibration or maintenance to service providers, where possible. Upon receipt of the equipment back on site, verify its status, maintain necessary records and appropriately clean/disinfect before use. Consideration should be given to performing installation qualification, where necessary.
如有可能，将设备送出现场进行再确认、校准或维护。在设备返回工厂后，确认其状态，保持必要的记录和适当的清洁/消毒之前使用。必要时应考虑执行安装确认。
Calibration or maintenance of equipment, facilities, utilities, systems to be remotely performed by the contractor using electronic means under the supervision of the organization.
在组织的监督下，由外包服务商使用电子手段远程操作设备、设施、公用系统和系统进行校准或维护。
Calibration or maintenance to be performed by an appropriately trained employee under the remote supervision of the contractor (e.g. video-conference).
由受适当培训的员工在外包服务商的远程监督下进行校准或维护(例如视频会议)。
Where equipment/system has two or more calibrated instruments measuring the same parameter and located in close proximity (e.g. thermometer for visual control and recording thermocouple of a cold room), the instrument with valid calibration status may be used to verify the validity of readings of the second instrument that is beyond its calibration due date, provided a documented risk assessment is performed and the outcome indicates that the risk is acceptable.
如果设备/系统有两台或两台以上已校准的仪器测量相同的参数，并且位置靠得很近(例如用于日常巡查温度计和记录冷库温度的热电偶)，有效校准状态的仪器可用于确认超出校准有效期的另一个仪器读数的有效性，条件是进行了书面的风险评估并且结果表明风险是可以接受的。


5. QUESTIONS RELATED TO MATERIAL
物料相关问题

5.1. How should organizations handle incoming materials and release of finished products?
组织应如何处理进料和成品放行？     

Materials received from external sources should be handled carefully to avoid any risk of contamination. In particular,
从外部来源接收的物料应小心处理，以避免任何污染风险,特别是：
Consideration should be given to clean and sanitize incoming materials received in their original containers or packs using suitable methods and sanitizers before transferring them to the warehouse storage.
应考虑使用适当的方法和消毒剂清洁和消毒收到的装于原装容器或包装中的物料，然后再将其转移到仓库储存。
Cleaning, sanitization and disinfection procedures should not compromise the quality of the materials nor the safety of the personnel.
清洁、消毒、消毒的程序不得影响物料的质量和人员的安全。
Sampling of incoming material should be performed following the approved procedure(s). The organizations should not reduce the established sampling process for APIs received for manufacturing finished products unless reduced sampling is appropriately validated in accordance with relevant guidelines.
对进料的取样应按照批准的程序进行。除非根据相关指南进行适当的验证，否则组织不应减少已建立的API取样程序。
Finished products should only be dispatched when they are fully tested and released. Poor hygiene practices should not lead to potential contamination or cross-contamination of the dispatched products with the coronavirus.
成品只有在经过充分测试和放行后才能发货。不应有易导致待运产品受冠状病毒污染或交叉污染的不良的卫生习惯。
Appropriate measures should be in place to track and trace the involvement of personnel, use of equipment and utilities. Adequate controls should be in place to ensure the product is stored under hygienic and approved conditions before it is shipped, during transit and considering possible delays in transit warehouses.
应采取适当措施，追踪和追溯人员参与、设备和公用系统的使用情况。应实行适当的控制措施，确保产品在运输之前、运输过程中以及考虑过境仓库可能出现的延误情况下，在卫生和经批准的条件下储存。


6. QUESTIONS RELATED TO PRODUCTION
与生产有关的问题

6.1. How should organizations continue to run production activities during the COVID-19 pandemic?
在新型冠状病毒肺炎大流行期间，组织应该如何继续进行生产活动？

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 (see also Q&A 3.1).
最高/高级管理层有责任根据风险管理原则，考虑国家法规、指南和措施，确定大流行期间需要维持的关键业务以及人员到厂工作还是在家办公 (另见问答3.1)。

In case contract workers are used, the organizations must ensure that the same hygiene and health requirements as for permanent employees are followed. Production and packaging operations should be performed according to established procedures. It should be ensured that any extra hygiene measures don't adversely affect the quality of products and are documented.
如果雇用合同工，必须确保符合与长期雇员相同的卫生和健康要求。生产和包装操作应按照既定程序进行。应确保任何额外的防护措施不会对产品质量产生不利影响，并有文件记录。

Documented evidence should be made available with each production and packaging activity performed to ensure traceability of personnel and operations. Process validation activities including media fills simulations should be performed in accordance with established procedures.
应提供每次生产和包装活动的书面证据，以确保人员和操作的可追溯性。工艺验证活动，包括培养基模拟灌装，应按照既定程序进行。


7. QUESTIONS RELATED TO QUALITY CONTROL LABORATORIES (MANUFACTURERS, NATIONAL AND PRIVATE LABS)
质量控制实验室（生产商实验室、国家实验室以及第三方实验室)相关问题

7.1. How do QCLs ensure activities are appropriately running during the COVID-19 pandemic?
QCLs如何确保活动在新型冠状病毒肺炎流感大流行期间正常运行？

Testing starting and packaging materials, intermediates and finished products are one of the main tasks of the quality control units and by independent (national and private) quality control laboratories. It must be ensured that all appropriate tests are conducted on incoming goods, materials and finished products and released only after their quality has been judged as satisfactory, as per usual practice. If national or private QCLs are responsible to perform testing as part of the batch release, the authorized person should continue to ensure completeness of testing before a product is released for sale. Contingency plans should be in place should the authorized person become infected or unable to perform his/her duties.
检测起始和包装材料、中间体和成品是质量控制单位和独立(国家和私营)质量控制实验室的主要任务之一。必须按照惯例，确保对进口货物、材料和制成品进行所有适当的测试，只有在其质量被判定为令人满意之后才予以放行。如果国家或私人qcl负责执行测试作为批量放行的一部分，QP应继续确保产品发布销售前测试的完整性。如QP受感染或无法执行职务，应制订应急计划。

The laboratory equipment and instruments should be qualified/ calibrated (see also Q&A 4.1) and handled appropriately such that they do not become a source of infection or cross-contamination of the coronavirus.
实验室设备和仪器必须经过确认/校正(另见问答4.1)和妥善处理，以免成为冠状病毒的感染源或交叉污染。

Additional cleaning and sanitization should be carried out for all surfaces, including surfaces that personnel are likely to touch, such as keyboards, mouse and computer screens associated with HPLC, GC, FTIR, UV-VIS and other laboratory equipment.
应对所有表面进行额外的清洁和消毒，包括人员可能接触的表面，如键盘、鼠标和与HPLC、GC、FTIR、UV-VIS和其他实验室设备相关的计算机屏幕。

7.2. Are QCLs allowed to perform skip or reduced testing during the COVID-19 pandemic?
在新型冠状病毒肺炎流感大流行期间，是否允许QCL进行跳过或减少测试？

It is the responsibility of the organizations to perform complete testing of incoming materials, intermediates and finished products following agreed specifications and method of analysis.
各组织有责任按照商定的标准和分析方法对进料、中间体和成品进行全面测试。

A science and risk-based approach for the evaluation and implementation of a reduced or skip testing program for the release of starting materials, intermediates, APIs, excipients, packaging components and finished products may be considered in accordance with regulatory guidelines. Organizations are required to notify their competent regulatory authorities and WHO PQT of their intention to conduct skip or reduced testing before its implementation. Based on the submitted evidence supporting documentation, a decision on the acceptance/rejection for skip testing will be communicated accordingly.
可以根据管理准则考虑采用科学和基于风险的方法，评价和执行减少或跳过的原料、中间体、原料药、辅料、包装部件和成品放行测试方案。在实施打算进行跳过或减少测试之前，各组织必须通知其主管监管当局和WHO PQT。基于所提交的证据支持文件，关于跳过测试的接受/拒绝的决定将被相应地通知。

7.3. Are QCLs allowed to perform skip or reduced testing on stability study samples during the COVID-19 pandemic?
在新型冠状病毒肺炎大流行期间，QCL是否允许对稳定性试验样品进行跳过或减少测试？

Skip or reduced testing may be considered for on-going stability studies. Organizations are required to notify their competent regulatory authorities and WHO PQT Unit of their intention to conduct skip or reduced testing before its implementation. Based on the submitted evidence supporting documentation, a decision on the acceptance/rejection for skip testing will be communicated accordingly.
在进行稳定性试验时可考虑跳过或减少试验。在实施跳过或减少测试之前，应通知其主管当局和WHO PQT部门。基于所提交的证据支持文件，关于跳过测试的接受/拒绝的决定将被相应地通知。

syhorchid

了解一下

xqliu

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ysyd

了解一下   

W虎背熊腰小蒸包

来学习，今天领导喊写风险评估

小金库

谢谢分享。