WHO发布HVAC系统指南修订版

翻译：julia 来自：蒲公英

GMP News
25/05/2016

WHO issues revised Guideline on HVAC Systems

WHO发布HVAC系统指南修订版

The World Health Organization (WHO) recently issued a guideline for commenting which describes the requirements for HVAC systems used for the manufacture of non-sterile dosage forms. As most guidelines on this topic address the requirements for sterile forms, the previous version (TRS 961, Annex 1) from 2011 was gladly accepted by industry. Mentioned are non-sterile dosage forms as tablets, capsules, liquids or ointments, but also for the final steps in the manufacture of APIs. The WHO guideline means to provide guidance specifically for the areas design, installation, qualification and maintenance of ventilation systems. For the manufacture of highly potent materials the WHO refers to their Guideline TRS 961, Annex 3.

WHO最近发布了指南征求意见，其中描述了非无菌制剂生产所用HVAC系统要求。由于此主题的大多数指南讲述的是无菌制剂的要求，之前的版本是2011年的（TRS 961附录1），药业很高兴地接受了。所提到的是非无菌制剂即片剂、胶囊、口服液或膏剂，也适用于原料药生产最后步骤。WHO指南是为了给通风系统的区域设计、安装、确认和维护提供指南。对于高效价物料的生产，WHO参考指南TRS 961附录3。

The biggest changes comprise: 最大的变更包括

• The chapter 'Premises' was moved to the front to emphasize its imp

  ortance. The chapter now further comprises some sample layouts  

• “设施”章节移到前面以强调其重要性。该章节现在进一步包括了一些平面样例。

• The section 'Commissioning, Qualification and Validation' was revised to match it with the  WHO Guideline TRS 937, Annex 4 (Supplementary guidelines on good manufacturing practices: validation) 

• “调试、确认和验证”部分进行了修订，以符合WHO指南TRS 937附录4（GMP指南补充：验证）

• The part 'Maintenance' was removed from the part 'Commissioning, Qualification and Validation' and is now a separte chapter

• “维护”部分从“调试、确认和验证”部分里拆出来，现在成了一个独立的章节

• In addition a number of comments were added, graphs revised, and the overall readability was improved

• 除了增加的大量意见外，图表也修订了，改善了全面可读性

Due to the many references and the numerous and improved illustrations the document is a good source for the (exemplary) requirements in the manufacture of solid and non-sterile dosage forms.

由于有许多参考文献，和大量的改善过的图示，文件现在成了固体和半固体制剂生产中（典型）要求的良好资源。

To find out more please visit the WHO website where you will find the draft document SUPPLEMENTARY GUIDELINES ON GOOD MANUFACTURING PRACTICES FOR HEATING, VENTILATION AND AIR-CONDITIONING SYSTEMS FOR NON-STERILE PHARMACEUTICAL DOSAGE FORMS. The deadline for comments is the 12 July 2016. The results are expected to be discussed during the 51st WHO expert committee meeting in October.

更多信息参见WHO官网，可以找到文件草案。征求意见截止日期为2016年7月12日，意见将在10月第51次WHO专家会议上讨论。