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 Particle Measuring Systems’ experts have put together on single topics covered by Annex 1 Rev 12 2020:
- 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
- Using a Risk Assessment to set microbiological plate incubation conditions
- Microbiological Plate Incubation
- Data Trending-Alert/Action Level Settings
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 Annex 1 compliant viable non viable instruments and data management solutions.
Annex 1 Insights: Knowledge / Papers
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?
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.
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 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.
The new chapter addition to the 2020 EU GMP Annex 1 for the Manufacture of Sterile Medicinal Products details viable and non-viable environmental and process monitoring to a degree not previously seen. It’s made clear that process monitoring and risk assessment is essential to the development of an effective contamination control strategy.
Annex 1 Compliant Particle Counters
This cleanroom microbial monitor is an innovative replacement for settle plates, provides up to 4 hour sampling, and minimizes false positives, resulting in a decrease in investigations.
Designed for intuitive and reliable portable and remote airborne particle counting. Meets all regulatory requirements.
Facility Monitoring System with industrial control assures data integrity, process automation, simplicity of use, and data integration.
The innovative microbial air sampler. ISO 14698:2003 compliant
Creates a complete contamination monitoring solution for pharmaceutical manufacturers.