Annex 1 Insights & Updates
The European Commission released their Annex draft for review and comment. Our experts have reviewed this document carefully and have shared their insights with you.
Here are some quick video snippets on single topics covered by Annex 1 Rev 12:
- 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)
- Science v. Standardization: Meeting auditor’s expectations by understanding the reasoning behind the rules
Stay tuned for more spinets or get a summary of the EU GMP Annex 1 Draft Revisions by reading the paper below or watching the on-demand webinar at the right. We also have FAQs with answers below. Also, scroll to the bottom for some of our GMP compliant products.
Annex 1 Insights: Knowledge / Papers
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.
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?
EU GMP Annex 1 Compliant Products
Cleanroom Microbial Monitor: BioCapt® Single-Use
This cleanroom microbial monitor is an innovative replacement for settle plates, provides 2 hr sampling, and minimizes false positives, resulting in a decrease in investigations.
Cleanroom Particle Counter: Lasair® III
Cleanroom particle counter sets the standard for cleanroom particle counters and meets the requirements of ISO 14644-1:2015 and ISO 21501-4.
Facility Monitoring System (FMS): FacilityPro®
Facility Monitoring System with industrial control assures data integrity, process automation, simplicity of use, and data integration.
Microbial Air Sampler: MiniCapt® Mobile
The innovative microbial air sampler. ISO 14698:2003 compliant
PharmaIntegrity Data Integrity
Creates a complete contamination monitoring solution for pharmaceutical manufacturers.
