Solutions to Ensure You Meet EU GMP Annex 1
Our experts have the knowledge and solutions to ensure you are Annex 1 compliant and beyond. This resource page includes on-demand webinars, papers, videos, and solutions at the bottom.
Begin by downloading one or both of our very popular Annex 1 guides:
Review of Annex 1 2022: Environmental Monitoring Changes
Annex 1 2022: Comparison to Previous Version
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 a preview of what is discussed in the Webinar on the right.
Annex 1 Insights & Updates
The European Commission released its 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.
Contact us today for a customized solution to meet your
environmental monitoring needs.
Annex 1 Insights: Knowledge / Papers
Annex 1 2022 Comparison to Previous Version
Annex 1 2022 Comparison to Previous Version
Introduction
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).
The new revision is a complete rewrite of the existing Annex 1 from 2008 and almost quadruples the length. It divides the document into 10 newly defined sections. One major sectioning change is the separation and differentiation of Certification (Section 4) and Monitoring (Section 9), which allows for expanded guidance and distinction between premise design/qualification and ongoing routine monitoring. There is a new section that discusses the concept of contamination control strategy (CCS). This section shifts to a new paradigm of incorporating CCS as a central holistic approach to how each aspect of contamination interacts with the facility as a whole. There is also a new section that discusses and identifies Quality Risk Management (QRM) as a central principle to defining processes, operations, and limits, and it ties to CCS to balance process against risk. Additionally, as laid out in the new revision, regulations for Environmental Monitoring is essentially the same with a few enhanced descriptions to better align with QRM.
See this paper (Review of Annex 1 2022) for further investigation of the new Annex 1 2022!
Review of Annex 1 2022: Environmental Monitoring Changes
Introduction
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 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.
EU GMP Annex 1 – Rev. 12 2020 – Insights and Updates
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
Microbial Monitor: BioCapt® Single-Use
This cleanroom microbial monitor is an innovative replacement for settle plates. In combination with an active air sampler, it provides Annex 1 compliant 2-hour sampling, and minimizes false positives, resulting in a decrease in investigations.
Lasair® Pro Aerosol Particle Counter
Designed for intuitive and reliable portable particle counting
Meets the latest data integrity requirementsFacility Monitoring System (FMS): FacilityPro®
Facility Monitoring System with industrial control assures data integrity, process automation, simplicity of use, and data integration.
MiniCapt® Mobile Microbial Air Sampler
The innovative microbial air sampler. ISO 14698:2003 compliant
Remote Air Sampler: MiniCapt®
Annex 1 compliant, remote microbial air sampler uses a unique HEPA-filtered exhaust to reduce contaminate introduction to your cleanroom.
Remote Particle Counter: IsoAir® Pro-E
A compact remote VHP resistant particle counter for an effective and flexible particle monitoring system.
Airnet® II / IIs Remote Particle Sensors (2 Channels)
The Airnet particle sensor meets the specifications of EU GMP Annex 1 and ISO 21501-4 to measure the size and number of particles suspended in the air for real-time monitoring of defect-causing particles.
Pharmaceutical Net Pro: Environmental Monitoring Software
Pharmaceutical Net Pro environmental monitoring software provides monitoring, reporting and management tool that delivers high reliability and data integrity.
PharmaIntegrity Data Integrity
Creates a complete contamination monitoring solution for pharmaceutical manufacturers.
Viable Cleanroom Monitor: BioCapt® Impactor
Viable cleanroom monitor enables the capture of viable particles on a suitable media surface for later incubation and enumeration.