D级洁净区洁净级别需每年进行确认吗?
设备确认与验证

如果可以定期确认,应如何进行风险评估?

2024-04-15 10:05 识林-树苗     
5个回答

2010版GMP未对D级区洁净级别的确认做强制规定。

2023版GMP指南 厂房设施与设备 中对于D级是有再确认要求的,并有相应的测试项目推荐


2024-04-19 16:20 JJF     

欧盟GMP附录1明确要求D级每年做再确认,其中包括洁净室分级。

据说中国GMP在修订中,应该逃不掉吧。

2024-04-19 18:14 Sumei     

如果在中国市场,没有法规明确,可以通过风险评估勉强吧,如果在欧盟市场必须做。


   

2024-04-17 13:45 陆云     

法规要求的项目就按法规要求做,如果不想每年写方案,可以出一个通用的规程或方案,可以每年纳入周期工作,然后采用ISPE第二版中的再确认评估方式开展,可以达到你想做的那种情况

EU GMP 附录一:4.32 The requalification of cleanrooms and clean air equipment should be carried out periodically following defined procedures. The requalification should include at a minimum the following:

4.32 应按照规定的程序定期对洁净室和洁净空气设备进行再确认。再确认应至少包括以下内容:

- Cleanroom classification (total particle concentration).-洁净室分级(总微粒浓度)。

- Integrity test of final filters.-最终过滤器的完整性测试。

- Airflow volume measurement.-风量测定。

- Verification of air pressure difference between rooms.-确认房间之间的压差。

- Air velocity test (Note: For grade B, C and D the air velocity test should be performed according to a risk assessment documented as part of the CCS. However, it is required for filling zones supplied with unidirectional airflow (e.g. when filling terminally sterilised products or background to grade A and RABS). For grades with non-unidirectional airflow, a measurement of recovery testing should replace velocity testing).-风速测试(注:对于B级、C级和D级,应按照风险评估进行风速测试,并记录作为CCS的一部分。但是,单向流的灌装区要求执行(例如,灌装最终灭菌产品时或A级和RABS的背景区)。对于非单向流的级别,恢复测试应代替风速测试)。

The maximum time interval for requalification of grade A & B areas, is 6 months.A级和B级区再确认的最长时间间隔为6个月。

The maximum time interval for requalification of grade C & D areas, is 12 months.C级和D级区再确认的最长时间间隔为12个月。

2024-04-17 10:22 漆白雪黑     

看品种了,EU GMP 附录一 的要求如下:The maximum time interval for requalification of grade A & B areas, is 6 months. The maximum time interval for requalification of grade C & D areas, is 12 months.


2024-04-15 19:54 亦心