标题: WHO发布HVAC系统指南修订版 [打印本页] 作者: aiyao 时间: 2016-5-26 08:39 AM 标题: WHO发布HVAC系统指南修订版 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.
The chapter "Premises" was moved to the front to emphasize its importance. 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.
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.