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近日，WHO发布了《设备/设施/系统确认指南》，本次将该指南原标题《Validation on qualification of systems, utilities and equipment（系统、设施和设备确认指南）》更名为《Guidelines on qualification（关于确认的指南）》：
该指南摘译如下（全文已上传网站，点击文章末端“阅读原文”或加入GMP办公室翻译组qq群：307361958 可获取）： 4. GENERAL 一般要求 4.1 The validation master plan, or other relevant document, should specify the policy, organization, planning, scope and stages applied in qualification on site, and should cover, e.g. production, quality control and engineering. 验证主计划，或其他相关文件应写明工厂确认工作的方针、组织、计划、范围和阶段，并应包括，如生产、质量控制和工程。 4.2 Quality risk management principles should be applied in qualification. 质量风险管理原则应被应用于确认。 4.3 The scope and extent of qualification and requalification should be determined based on the principles of impact assessment and risk management principles. 确认和再确认的范围和程度应基于影响性评估原则和风险管理原则确定。 4.4 Qualification should be executed by trained personnel. Training records should be maintained. 确认应由经培训的人员执行。确认记录应被保留。 4.5 Where appropriate, new premises, systems, utilities and equipment should be subjected to all stages of qualification. This includes the preparation of user requirement specifications (URS), design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). 适当时，新厂房、系统、设施和设备应经过所有阶段的确认。包括用户需求规范（URS）的准备、设计确认（DQ）、安装确认（IQ），运行确认（OQ）和性能确认（PQ）。 4.6 Justification should be provided where it is decided that not all stages of qualification are required. 若决定不进行所有阶段的确认，应说明理由。 4.7 Qualification should be done in accordance with predetermined and approved qualification protocols. 确认应依据预先确定并经批准的确认方案执行。 4.8 The results of the qualification should be recorded and reflected in qualification reports. 确认的结果应被记录并反映于确认报告。 4.9 There should be a logical sequence for executing qualification including such as premises (rooms), then utilities and equipment 确认的执行应有一个逻辑顺序，包括例如，先进行厂房（洁净室），然后设施和设备。 4.10 Normally, qualification stages should be sequential. (For example, operational qualification should follow after the successful completion of installation qualification.) In some cases, different stages of qualification may be executed concurrently. 通常，各确认阶段应该是连续的。（例如，应在安装确认成功完成后进行运行确认）某些情况下，不同阶段的确认也可以同步进行。 4.11 Equipment should be released for routine use only once there is documented evidence that the qualification has been successful. 只有当文件证明确认成功后，设备才可以放行作提出使用。 4.12 Certain stages of the qualification may be done by a supplier or a third party, subject to the conditions and responsibilities as defined in a written agreement between the parties. The contract giver remains responsible to ensure that the qualification is done in accordance with the principles of good manufacturing practices (GMP). 确认的某一个阶段可以由供应商或第三方机构来执行，依双方书面协议中定义的条件和责任。合同供方应确保所执行的确认符合GMP原则。 4.13 The relevant documentation associated with qualification, including standard operating procedures (SOPs), specifications and acceptance criteria, certificates and manuals, should be available. 确认相关的文件，包括标准操作规程（SOP），标准和接受标准，证书和手册应该可用。 4.14 Utilities and equipment should be maintained in a qualified state and should be periodically reviewed for the need for requalification. Requalification should be considered when changes are made. 设施和设备应被维护在一个已确认状态并定期回顾以评估再确认的必要性。变更后应进行再确认。 5. USER REQUIREMENT SPECIFICATIONS 用户需求规范 5.1 URS should be prepared for but not limited to, utilities and equipment, as appropriate. 包括但不限于设施和设备，都应有URS。 5.2 URS should be used at later stages in qualification to verify that the purchased and supplied utility or equipment is in accordance with the user’s needs. 在确认的后续阶段应使用URS来确认所购买的和供应的设施或设备符合其用户需求。 6. FACTORY ACCEPTANCE TEST AND SITE ACCEPTANCE TEST 工厂验收测试和现场验收测试 6.1 Where a utility or equipment is assembled, or partially assembled at a site other than that of the purchaser or end-user, testing and verification may be done, based on quality risk management principles, to ensure that it is appropriate and ready for dispatch. 当设施或设备在买方之外其他场地或最终使用方场地完成组装或部分组装，根据风险管理原则，可以进行测试和确认以确认其适用并可以发货。 6.2 The checks and tests during factory acceptance test (FAT) should be recorded. 工厂验收测试（FAT）期间进行的检查和测试应被记录。 6.3 The acceptability of the assembly and overall status of the utility or equipment should be described in a conclusion of the report for the FAT, prior to shipment. 在发运前，FAT报告的结论应描述设施或设备的装配和总体状态的可接受性。 6.4 Tests, based on quality risk management principles, may be performed to verify the acceptability of the utility or equipment when it is received at the end-user. This is a site acceptance test (SAT). 根据风险管理原则，设施或设备的可接受性测试可以在最终用户接收后进行，此为现场验收测试（SAT）。 6.5 The results of the tests should be recorded and the outcome of the acceptability of the utility or equipment should be recorded in the conclusion section of the report for the SAT. 应记录测试的结果，并在SAT报告的结论章节记录设施或设备的可接受性。 7. DESIGN QUALIFICATION 设计确认 7.1 DQ should demonstrate that the system, as designed, is appropriate for its intended use as defined in the URS. DQ应证实所设计的系统符合其URS中定义的预期用途。 7.2 A suitable supplier should be selected and approved for the relevant utility or equipment. 应选择批准适当的设施或设备的供应商。 8. INSTALLATION QUALIFICATION 安装确认 8.1 Utilities and equipment should be correctly installed, in an appropriate location. 设施和设备应安装正确，在合适的位置。 8.2 There should be documented evidence of the installation. This should be in accordance with the IQ protocol which contains all the relevant details. 安装应有文件证实。应符合IQ方案，包含所有相关细节。 8.3 IQ should include identification, verification and installation of relevant components identified, e.g. services, controls and gauges. IQ应包括相关部件的鉴定、核实和安装，如服务器、控制器和测量。 8.4 Identified measuring, control and indicating devices, should be calibrated on site unless otherwise appropriately justified. The calibration should be traceable to national or international standards. Traceable certificates should be available. 仪器、控制和显示设备的校准应在现场进行，除非经过适当论证。校准应可追溯至国家或国际标准。应有可追溯的证书。 8.5 The execution of the protocol should be recorded in the report. 方案的执行应在报告中记录。 8.6 The report should include, e.g. the title, objective, site, details of the supplier and manufacturer, system or equipment name and unique identification number, model and serial number, date of installation, tests executed, components and their identification numbers or codes and material of construction, actual results of tests and measurements, relevant procedures followed for tests and certificates as applicable. 报告应包括，如标题、目的、位置、供应商和生产商的详细信息、系统或设备的名字以及唯一编号、型号和序列号、安装日期、所执行的测试、部件及其标识号或代码以及构成材料、测试的实际结果和测算、检验遵循的相关规程和证书（如适用）。 8.7 Deviations and non-conformances including those from URS, DQ and acceptance criteria specified and observed during installation should be recorded, investigated, and corrected or justified. 偏差和不符合情况应被记录，调查和纠正或论证，包括那些不符合URS、DQ和既定接受标准的情况。 8.8 Normally, the outcome of the IQ should be recorded in the conclusion of the report, before OQ is started. 通常，在OQ开始前，应在报告的结论中记录IQ的结果。 8.9 Requirements and procedures for calibration, maintenance and cleaning should normally be prepared during IQ or OQ. 校准、维护和清洁的要求和规程通常应在IQ或OQ期间完成。 9. OPERATIONAL QUALIFICATION 运行确认 9.1 Utilities and equipment should operate correctly and their operation should be verified in accordance with an OQ protocol. OQ normally follows IQ but depending on the complexity of utility or equipment, it may be performed as a combined installation/operation qualification(IOQ). 设施和设备应正确运行，并且其运行应被确认符合OQ方案。OQ通常在IQ之后，但是根据设施或设备的复杂性，也可以组合进行安装/运行确认（IOQ）。 9.2 OQ should include but is not limited to the following: OQ应包括但不限于如下： - tests that have been developed from the knowledge of processes, systems and equipment to ensure the utility or equipment is operating as designed; 基于工艺、系统和设备知识而进行的测试，以确保设施或设备按照设计运行。 - tests to confirm upper and lower operating limits, and/or “worst case” conditions. 用以确认操作上下限度范围和或“最差条件”的测试。 9.3 Training of operators for the utilities and equipment should be provided and training records maintained. 应对设施和设备的操作人员进行培训，并有培训记录。 9.4 Calibration, cleaning, maintenance, training and related tests and results should be verified to be acceptable. 校准，清洁，维护，培训和相关测试以及结果应被确认可以接受。 9.5 Deviations and non-conformances observed should be recorded, investigated and corrected or justified. 偏差和不符合情况应被记录，调查和纠正或论证。 9.6 The results for the verification of operation should be documented in the OQ report. The outcome of the OQ should be recorded in the conclusion of the report, normally before PQ is started. 运行确认的记过应被记录于OQ报告中。通常在PQ开始前，OQ的结果应被记录于报告的结论中。 10. PERFORMANCE QUALIFICATION 性能确认 10.1 PQ should normally follow the successful completion of IQ and OQ. In some cases it may be appropriate to perform PQ in conjunction with OQ or process validation. PQ一般在IQ和OQ成功完成后进行。某些情况下，PQ与OQ或工艺验证联合进行，也是合适的。 10.2 PQ should include, but is not limited to the following: PQ应包括但不限于，如下： - tests, using production materials, qualified substitutes or simulated products proven to have equivalent behaviour under normal operating conditions with worst case batch sizes where appropriate; 测试，适当时，在最长条件批量下使用经证实在正常操作条件下具有同等行为的生产物料、经确认的替代品或模拟产品。 - tests should cover the operating range. 测试应覆盖运行范围。 10.3 Utilities and equipment should consistently perform in accordance with their design specifications and URS. The performance should be verified in accordance with a PQ protocol. 设施和设备性能应一贯地符合其设计标准和URS。其性能确认应按照一份PQ方案进行。 10.4 There should be records (e.g. PQ report) for the PQ to indicate the satisfactory performance over a predefined period of time. Manufacturers should justify the period over which PQ is done. PQ应有记录（如PQ报告）表明其在规定时间内性能符合要求。生产商应论证PQ完成的时间。 11. PERIODIC REVIEW AND REQUALIFICATION 定期回顾和再确认 11.1 Utilities and equipment should be maintained in a qualified state through the life cycle of the utility or equipment. 设施和设备应在其生命周期内被维护在一个已确认的状态。 11.2 Utilities and equipment should be reviewed periodically to confirm that they remain in a qualified state and to determine the need for requalification. 设施和设备应被定期回顾以确认其保持在已确认状态并确定再确认的必要性。 11.3 Where the need for requalification is identified, this should be performed. 当再确认的需求被确定，则需要进行。 11.4 Risk management principles should be applied in the review and requalification and the possible impact of small changes over a period of time should further be considered. 在回顾和再确认时应使用风险管理原则，并进一步考虑微小变更累积的可能影响。 11.5 Risk management principles may include factors such as calibration, verification, maintenance data and other information. 风险管理原则应包括因素如校准、检定、维护数据和其他信息。 11.6 The qualification status and requalification due dates should be documented, e.g. in a qualification matrix, schedule or plan. 应文件规定确认状态和再确认有效期，例如在一份确认矩阵，日程表或计划中。 11.7 In case a utility or equipment in use is identified, where it had not been subjected to qualification, a qualification protocol should be prepared where elements of URS, design specifications, operation and performance are verified for acceptability. The outcome of this qualification should be recorded in a report. 为避免一个在用的设施或设备未经过确认，应有一个确认方案确认诸如URS、设计规范、运行和性能符合接受标准。确认的结果应被记录于一个报告中。     公众号 GMP办公室 
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