附录1 解析&更新
欧盟委员会公布了GMP附件草案,待审核和评论。PMS专家详细研读这份文件后,将自己所得见解进行了整理。
PMS美国粒子监测系统公司专家根据2020新版GMP附录1中的不同主题制作了以下视频:
- Update: Continuous Viable Monitoring
- Alternative Micro Methods and Rapid microbial
- Single Use Considerations and a solution
- Cleaning & Disinfection: What you need to know
- Classification – Qualification – Monitoring
- Quality Risk Management (QRM)View Page
- Using a Risk Assessment to set microbiological plate incubation conditions
- Data Trending-Alert/Action Level Settings
通过阅读下面的文章或观看网络研讨会视频,收获欧盟GMP附录1草案修订相关的要点或摘要。以及常见问题和答案。此外,滚动到底部还能够了解到GMP附录1相匹配的粒子和浮游菌监测设备和数据管理解决方案。
GMP附录1解析:知识点/白皮书
EU Annex 1:Impact on Environmental Monitoring for Clean Manufacturing
On December 20th, the first draft for a Revision of EU ANNEX 1 was published for public comment. Particle Measuring Systems put together a team of industry experts to provide their insights of the new aspects of environmental monitoring in sterile manufacturing and its probably implications to Pharmaceutical manufacturers.
Annex 1 Revision 2017 Comments from Industry Experts
The updated EU GMP Annex 1 Draft was released for public comment in December 2017, and the industry experts at Particle Measuring Systems have shared their response on the revision.
Viable Monitoring Solutions to Prepare Your Contamination Control Strategy (CCS) for Annex 1 FAQ
Viable monitoring requirements and solutions per the latest Annex 1 draft (rev 12) are discussed here by industry experts. Watch the on-demand webinar and access FAQS here.
Concerned about how Annex 1 might affect you?
Industry experts answer over 40 common Annex 1 draft questions including:
- During cleanroom classification, is it mandatory to monitor viable and non-viable counts simultaneously?
- Can you choose not to use one of the microbiological sampling methods for qualification of a classified area?
- Does the removal of the 5 micron particle size from ISO 14644 mean the qualification time for Grade A and B will be vastly reduced?
- Have particle sizes greater than 5.0 been removed as a requirement of Grade A or B monitoring?
GMP附录1匹配粒子计数器
微生物监测采样头: BioCapt® Single-Use
这款洁净室微生物监测仪是沉降皿的优选替代品,采样时长可达2小时,并有效减少假阳性,从而减少调查次数。
Lasair® III 便携式粒子计数器
LASAIR®III便携式粒子计数器充分满足了便携式粒子计数器的标准,符合ISO1464—1:2015和ISO21501-4要求。
FacilityPro®环境监测系统
工业控制系统保证数据完整性、过程自动化、使用的简便性和数据集成。
MiniCapt®微生物采样器
新型微生物采样器,符合ISO 14698:2003标准。
PharmaIntegrity Data Integrity
为制药企业创建一个完整的污染监测解决方案。