20151022 ECA新闻：WHO公布非无菌制剂用HVAC系统指南草案

20151022 ECA新闻：WHO公布非无菌制剂用HVAC系统指南草案  

GMP News
22/10/2015

WHO publishes draft guideline for HVAC systems for non-sterile pharmaceutical dosage forms

WHO公布非无菌制剂用HVAC系统指南草案

Nearly all guidelines addressing the requirements with regard to HVAC systems or air qualities focus on the manufacture of sterile medicinal products. This is especially true for the Annex 1 of the EU GMP Guideline.

几乎所有关于HVAC系统或空气质量的指南都在关注的是无菌药品的生产，特别是EU GMP指南的附录1.

The WHO now published a revised working document of the guideline for public consultation which specifically addresses the requirements for HVAC systems used during the manufacture of non-sterile pharmaceutical dosage forms. The version valid so far dates back to 2011 and is contained in the WHO Technical Report Series, No. 961 as Annex 5 (Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms). The main changes are the integration of sample layouts (such as for weighing and dispensing) in the chapter "Premises" and a revision of the chapter "Commissioning, Qualification and Validation". Furthermore, a separate chapter now is devoted to maintenance.

WHO现在公布了修订后的工作文件征求意见，其中特别强调了非无菌药品制剂生产用HVAC系统的要求。目前有效版本还是2011年的，是在WHO的第961号技术报告中作为附录5（非无菌制剂生产用HVAC系统优良生产规范补充指南）。主要变更是在“设施”章节里包括了取样平面图（例如，称重和分料），并且对“调试、确认和验证”章节进行了修订。另外，现在新建了一个独立的章节给维保。

You can find the current draft of the "Guideline Supplementary guidelines on GMPs for HVAC systems for non-sterile pharmaceutical dosage forms" in the members' area of the ECA website.

你可以在

ECA

网页上会员区里找到现行的“非无菌制剂药品生产用

HVAC

系统

GMP

补充指南”草案。

转自：http://zhuyujiao1972.blog.163.com/blog/static/9869472720159221044061/