• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

+41 71 987 01 01

  • Youtube
  • Linkedin
  • English / CH
    • 中文
    • 台灣
    • Singapore
    • Denmark
    • English
    • Français
    • Français / CH
    • Deutsch
    • Deutsch / CH
    • Deutsch / AT
    • Italiano
    • 日本語
    • 한국어
    • Português, Brazil
    • Español
Newsletter

Search

Particle Measuring Systems
Without measurement there is no control
Get a Quote
  • Home
  • Products
    • Air
    • Liquids
    • Microbial Samplers
    • Compressed Gases
    • Molecular
    • Software / Data Management
  • CAS Clean Air Services
    • Cleanroom Measurement Services
      • Smoke Studies
    • Thermal Validation
  • Education
    • PMS™ Knowledge Center
      • Particle Counting Education
      • Beginner Guide to Particle Counting
      • Contamination Monitoring Videos
      • Webinars – Archived
    • Blog
  • Applications
    • Industries
      • Hospital Regulatory Compliance Services
      • Pharma
      • Cosmetics & Personal Care
      • Aerospace
      • Photonics & Optics
      • Semi
    • ISO 14644
    • ISO 21501-4
    • USP 797
    • USP 788
    • Parts Cleanliness Testing
    • Annex 1
    • 21CFR 11
  • Service and Support
    • Product Calibration & Service
      • Balometers
      • Anemometers
    • Project Management
    • Hardware & Software Support
    • Customer Service
  • About Us
    • Contact Particle Measuring Systems
    • Why Outsource With CAS
    • Why Choose US
    • Credibility & Registrations
    • Careers
    • Executive Team
    • Press Releases
    • Corporate Responsibility, Sustainability, Health & Safety
    • COBE
    • About Spectris
    • Trademarks & Patents
    • Anti-Slavery
    • Export Compliance

Annex 1 Environmental Monitoring Solutions for Your Contamination Control

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:

  1. Update: Continuous Viable Monitoring
  2. Alternative Micro Methods and Rapid Microbial
  3. Single Use Considerations and a Solution
  4. Cleaning & Disinfection: What you need to know
  5. Classification – Qualification – Monitoring
  6. Quality Risk Management (QRM)
  7. Using a Risk Assessment to set microbiological plate incubation conditions
  8. Microbiological Plate Incubation
  9. 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!

    read all

  • 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).

    read all

  • 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.

    read all

  • EU GMP Annex 1 – Rev. 12 2020 – Insights and Updates

    EU GMP Annex 1 Insights

    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.

    read all

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 requirements

  • Facility 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

    PharmaIntegrity Data Integrity

    Creates a complete contamination monitoring solution for pharmaceutical manufacturers.

  • BioCapt® viable cleanroom monitor

    Viable Cleanroom Monitor: BioCapt® Impactor

    Viable cleanroom monitor enables the capture of viable particles on a suitable media surface for later incubation and enumeration.

Learn more about these Annex 1 solutions

Review of Annex 1 2022: Environmental Monitoring Changes

EU GMP Annex 1 has been released after much anticipation, and the trail of revisions has caused confusion. PMS has put two of our experts to the task of explaining the environmental monitoring requirements, providing practical solutions, and answering your questions.

  • Mark HallworthPresenter

    Mark Hallworth

    Life Sciences Global Manager and Sr. GMP Scientist, Particle Measuring Systems
  • Presenter

    David Crance

    Life Sciences and OEM Sales Manager, Particle Measuring Systems
Watch Now

Ask a Question

Einstein image

Do you have an EU GMP Annex1 question? Read our frequently asked questions (FAQ's) below or submit your specific question and one of our experts will respond shortly.

Contact Us

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • Molecular Monitors
  • BioCapt® Certificate of Analysis (CofA)
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Contamination Monitoring Solutions for the Photonics & Optics Industry
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

Service & Support

Knowledge Center

  • COBE
  • Contact Particle Measuring Systems

About Us

  • COBE
  • Contact Particle Measuring Systems

Particle Measuring Systems EN-CH

Reinluftweg 1
9630 Wattwil, Switzerland

T: +41 79 261 67 41
E: [email protected]

Keep in touch! Receive industry news from us:

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • Molecular Monitors
  • BioCapt® Certificate of Analysis (CofA)
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Contamination Monitoring Solutions for the Photonics & Optics Industry
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

Applications

  • ISO 21501-4
  • USP 788
  • Parts Cleanliness Testing

Service & Support

Education and Training

  • PMS™ Knowledge Center

About Us

  • COBE
  • Contact Particle Measuring Systems

Particle Measuring Systems- EN/CH

Reinluftweg 1
9630 Wattwil, Switzerland

T: +41 79 261 67 41
E: [email protected]

Keep in touch! Receive industry news from us:

  • Website Disclaimer
  • Third Party Privacy Notice
  • Privacy Policy
  • Legal

© Copyright 2023 - Particle Measuring Systems is a Spectris company