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近日，WHO发布了《GOOD MANUFACTURING PRACTICES FOR HEATING, VENTILATION AND AIR-CONDITIONING SYSTEMS FOR NON-STERILE PHARMACEUTICAL DOSAGE FORMS: PART 2 INTERPRETATION OF PART 1 – GMP FOR HVAC SYSTEMS（非无菌制剂暖通空调GMP指南：第二部分——HVAC系统GMP）》，该指南计划于2018年10月22~26日提交给ECSPP第53次会议。 该指南总结如下（部分）：
该指南结构如下： Section 1 and 2. Introduction and Scope 章节1和2：简介和范围 3. Glossary 术语 4. Premises 厂房 5. Design of HVAC systems and components HVAC系统和部件的设计 6. Full fresh air and recirculation systems 全新风和再循环系统 7. Air filtration, airflow direction and pressure differentials 空气过滤、气流流型和压差 8. Temperature and relative humidity 温度和相对湿度 9. Dust, vapour and fume control 粉尘、烟雾控制 10. Protection of the environment 环境保护 11. Commissioning 试车 12. Qualification 确认 13. Maintenance 维护 原文已上传网站，点击文章末端“阅读原文”下载，全文正在翻译，欢迎加入GMP办公室翻译组qq群：307361958参与翻译 部分章节翻译如下： Section 9. Dust, vapour and fume control 章节9 粉尘、烟雾控制 Manufacturers should ensure that dust-generated vapours and fumes are effectively removed from the manufacturing areas. Extraction or collecting systems should be designed and qualified to demonstrate this. Sufficient air velocity should be maintained in such systems to effectively remove dust and vapours. 生产商应确保粉尘产生的烟雾从生产区域有效清除。应设计排风和捕集系统并确认可行。该系统应维持足够的气流速度以有效清除粉尘和烟雾。 A dust extractor should normally not serve different rooms where different products can be processed at the same time due to the risks such as backflow or flow from room to room resulting in possible contamination and cross-contamination. 当存在同一时间生产不同产品时，一个除尘器通常不应在不同房间工作，因存在诸如从一个房间到另一个房间返流或流动，导致可能的污染和交叉污染。 Wherever possible, dust or vapour contamination should be removed at source, i.e. as close as possible to the point where the dust is generated. Dust extraction ducting should be designed with sufficient transfer velocity (determined by the manufacturer depending on materials and products processed) to ensure that dust is carried away, and does not settle in the ducting (a guidance value is 15–20 m/s). 如有可能，应在源头清除粉尘或气雾污染，如尽可能靠近产尘区。除尘管道应被设计具备足够的传输速度（由生产商根据所加工的物料和产品决定）以确保粉尘清除，而不滞留在管道内（指导值：15-20m/s）。 Section 12. Qualification 章节12 确认 Manufacturers should consider all stages of qualification for their HVAC systems. This includes, where appropriate, user requirement specification, design qualification, factory acceptance test, site acceptance test, installation qualification, operational qualification and performance qualification. Qualification to be done over the life cycle of the HVAC system should be described and executed including, e.g. when changes are made to the system. 生产商应考虑对HVAC系统进行所有阶段的确认。这包括，适当时，用户需求规范（URS）、设计规范、工厂验收测试、现场验收测试、安装确认、运行确认和性能确认。应描述并执行HVAC系统生命周期中进行的确认，包括如但系统发生变更时。 Validation master plan(s), protocols, reports and source data for tests should be available. The scope and extent of qualification should be determined based on risk assessment. Parameters with limits included in qualification (such as temperature test, airflow direction, viable and non-viable particle counts) should be justified by manufacturers. The procedures followed for the performance of the tests should generally be in line with the standard as described in ISO 14644. 应有验证主计划、方案、报告和测试源数据。确认的范围和程度应基于风险评估确定。生产商应论证确认（如温度测试、气流流向、活性和非活性粒子计数）中所包含的参数范围。测试所遵循的程序通常应与ISO14644一致。 Some of the typical HVAC system parameters that should be included in the tests during qualification are listed below. It is recommended that the tests be done at defined intervals. The tests typically cover: 确认期间测试应包括的典型的HVAC系统参数罗列如下。建议测试在规定时间进行。测试包括如下： — temperature; 温度 — relative humidity; 相对湿度 — supply air quantities; 送风质量 — return air or exhaust air quantities; 回风或排风质量 — room air-change rates; 房间换气次数 — pressure differentials; 压差 — airflow direction test; 气流流型测试 — installed filter leakage tests; 过滤器泄漏测试 — particle counts; 悬浮粒子计数 — clean-up or recovery rates; 自净/恢复时间 — microbiological counts; 微生物计数 — warning/alarm systems. 报警系统 Table 1. Considerations in testing 表1 测试的考虑点
Switching off of AHUs AHU的切换 It is recommended that the HVAC system be operational on an ongoing basis. Where a manufacturer decides to use energy saving modes or switch some selected AHUs off at specified intervals such as overnight, weekends or extended periods of time, care should be taken to ensure that materials and products are not affected. In such cases, the decision, procedures and records should be sufficiently documented and should include risk assessment, standard operating procedures (SOPs), records and validation. This includes procedures and records for the start-up and shut-down sequence of air handling units. 建议HVAC系统持续运行。当决定在特定时间使用节能模式或选择关闭部分AHU，如夜间、周末或很长时间，应关注确保物料和产品不受影响。这种情况下，应充分记录该决定、规程和记录，并包括风险评估、标准操作规程（SOP）、记录和验证。这包括风机处理单元（AHU）的开启和关闭顺序的规程和记录。  公众号 GMP办公室
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