**Free Upcoming Webinar – October 6**
Review of Annex 1 – 2022: Environmental Monitoring Changes
In our first educational webinar since the release of Annex 1, PMS has put two of our experts to the task of explaining the environmental monitoring requirements, providing practical solutions, and answering your questions about the finalized EU GMP Annex 1 regulation.
Register here —>
In this interview, Mark Hallworth, Sr. GMP Scientist, Particle Measuring Systems, discusses the new EU GMP Annex 1 release. Topics discussed include Annex 1’s history, timing, changes, and next steps. Also included is a preview of what will be covered in the upcoming webinar.
Annex 1 Insights & Updates
The European Commission released their long awaited Annex 1 regulation in August 2022. Our experts have reviewed this document carefully and have shared their insights with you.
Below are some quick video snippets Particle Measuring Systems’ experts have put together on single topics covered by Annex 1:
- 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)
- Using a Risk Assessment to set microbiological plate incubation conditions
- Microbiological Plate Incubation
- Data Trending-Alert/Action Level Settings
Stay tuned for more snippets, or get a summary of the EU GMP Annex 1 requirements by reading the papers and FAQ’s below, or by watching the on-demand webinar at the right.
Scroll to the bottom for more of our Annex 1 compliant viable nonviable instruments and data management solutions.
Annex 1 Insights: Knowledge / Papers
In August 2022, a new revision of the EU GMP Annex 1 regulatory standard for sterile drug products was released, replacing the most recent draft from 2020 and the existing revision from 2008. The deadline for operational use of the new standards is August 25, 2023: a year after the release. These requirements regulate the manufacturing of sterile drugs made in and imported to the EU. Pharmaceutical manufacturing is performed in controlled environments to reduce contamination, and changes recently announced by Annex 1 focus more on strategic control than on measurement of quality. This new revision also better aligns the manufacturing principles contained in the Annex 1 to those presented by the World Health Organization (WHO), Pharmaceutical Inspection Cooperation Scheme (PIC/S), and US Food and Drug Administration (FDA).
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
The innovative microbial air sampler. ISO 14698:2003 compliant
This cleanroom microbial monitor is an innovative replacement for settle plates, provides 2-hour sampling, and minimizes false positives, resulting in a decrease in investigations.
Microbial remote air sampler uses a unique HEPA-filtered exhaust so it doesn’t contaminate your cleanroom.
Designed for intuitive and reliable portable particle counting
Meets the latest data integrity requirements
Facility Monitoring System with industrial control assures data integrity, process automation, simplicity of use, and data integration.
Creates a complete contamination monitoring solution for pharmaceutical manufacturers.