是否需要执行更新后的ISO14644？

新的ISO 14644发布，但EU GMP附录1更新还未发布，要按什么标准检测？EMA在其官网上的问答中给出了回答。

EUGMP guide annexes: Supplementary requirements: Annex 1: Manufacture of sterilemedicinal products

 

7. Do Ineed to follow the requirements of the updated ISO 14644 part 1 standard?

Annex1 of the EU GMP guide is currently under revision and will take account of theupdated ISO standard. In the meantime, for qualification or re-qualification ofclean room facilities, medicinal productmanufacturers may apply the updated ISO standard with reference to Annex C(counting of macroparticles), or may continue to follow the previous ISOstandard. Routine monitoring, however, should continue to be carried out inaccordance with the existing Annex 1.

EUGMP指南附录：补充要求：附录1：无菌药品生产

 

7.我需要执行更新后的ISO14644第一部分标准要求吗？

EUGMP指南附录1目前正在修订中，其修订将考虑更新后的ISO标准。同时，对洁净区的确认和再确认来说，药品生产商可以应用更新后的ISO标准，参考附录C（微粒计数），也可以继续执行之前的ISO标准。日常监测则应根据现有附录1执行。

 

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000027.jsp&mid=WC0b01ac05800296ca