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

+1-303-443-7100

 

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

Search

  • Linkedin
  • Twitter
Particle Measuring Systems
Without measurement there is no control
Get a Quote
  • Home
  • Particle Counters
    • Airborne Particle Counters
    • Liquid Particle Counters
    • Microbial Samplers
      • BioCapt®Certificates of Analysis
    • Compressed Gases Particle Counters
    • Molecular Monitors
    • Environmental Monitoring Systems
  • Education
    • Knowledge Center
      • Papers
      • Webinars
      • Videos
      • Beginner Guide
    • Particle College
    • Training Services
    • Blog
  • Applications
    • Industries
      • Pharmaceutical
      • Semiconductor
      • Photonics & Optics
      • Aerospace
      • Cosmetics & Personal Care
      • Food & Beverage Safety
    • Annex 1
    • ISO 14644
    • 21CFR 11
    • ISO 21501-4
    • USP 788
    • USP 797
    • Continuous Viable Monitoring
    • Parts Cleanliness Testing
  • Services and Support
    • Product Calibration & Service
    • FMS/EMS Project Management
    • Contamination Control Advisors
    • Hardware & Software Support
    • Customer Service
  • About PMS
    • About Us
    • Contact Us
    • Why Choose PMS
    • Executive Team
    • Careers
    • Corporate Responsibility
    • COBE
    • Parent Company
    • Press Releases
    • ISO Registrations & Quality Policy
    • Trademarks & Patents
    • Anti-Slavery
    • Export Compliance
Application Note

EU GMP Annex 1 – 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.

Trend analysis and its impact on the contamination control strategy is now an essential activity and is referenced multiple times. There is also clear differentiation between qualification and monitoring, and quality risk management concepts are interwoven into each section.

Here are just a few of the topics this paper covers:

  • System Design
  • Monitoring
  • Cleaning and Disinfection
  • Risk Assessment
  • Microflora
  • Events and Deviations
  • More…

Interested in learning more? 

Complete the form on the right to get the full Beginner Guide to Annex 1.

 

Particle Measuring Systems has complete cleanroom contamination control solutions for you including:

  • Our Contamination Control Advisory Services who can conduct an expert Risk Assessment for your pharmaceutical processes
  • PMS cleanroom particle counters including portable/mobile and fixed/remote
  • Microbial monitors including portable/mobile, fixed/remote, and single use.
  • Data management software from Particle Measuring Systems

Contact us today to learn more about how we can help you with your compliance efforts.

 

Get this paper now

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters for Chemical and Water Particle Monitoring Applications
  • Microbial Samplers
  • BioCapt®Certificates of Analysis
  • Compressed Gas Particle Counters
  • Molecular Monitors
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Photonics & Optics
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

Service & Support

  • Advisory Service
  • Product Calibration and Service
  • Customer Service

Knowledge Center

  • Particle Counting Education
  • Particle College – Electronics Industry Focused
  • Contamination Monitoring Videos
  • Blog

About Us

  • Contact Particle Measuring Systems
  • Why Choose Particle Measuring Systems
  • Particle Measuring Systems’ Executive Team
  • Careers
  • Corporate Responsibility
  • COBE
  • Parent Company
  • Press Releases
  • ISO Registrations & Quality Policy
  • Trademarks & Patents
  • Anti-Slavery
  • Export Compliance

Particle Measuring Systems- USA

Corporate Headquarters
5475 Airport Blvd.
Boulder, CO 80301

T. +1 303-443-7100
F. +1 303-440-1090
E. [email protected]

Keep in touch! Receive industry news from us:

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters for Chemical and Water Particle Monitoring Applications
  • Microbial Samplers
  • BioCapt®Certificates of Analysis
  • Compressed Gas Particle Counters
  • Molecular Monitors
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Photonics & Optics
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

Applications

  • ISO 14644
  • ISO 21501-4
  • USP 797
  • Meet USP 788 Particulate Matter in Injections
  • Parts Cleanliness Testing
  • Annex 1 Latest Draft Revision Updates
  • 21CFR 11

Service & Support

  • Advisory Service
  • Product Calibration and Service
  • Customer Service

Education and Training

  • Knowledge Center
  • Particle College – Electronics Industry Focused
  • Software / Data Management
  • Blog

About Us

  • Contact Particle Measuring Systems
  • Why Choose Particle Measuring Systems
  • Particle Measuring Systems’ Executive Team
  • Careers
  • Corporate Responsibility
  • COBE
  • Parent Company
  • Press Releases
  • ISO Registrations & Quality Policy
  • Trademarks & Patents
  • Anti-Slavery
  • Export Compliance

Particle Measuring Systems- USA

Corporate Headquarters
5475 Airport Blvd.
Boulder, CO 80301

T. +1 303-443-7100
F. +1 303-440-1090
E. [email protected]

Keep in touch! Receive industry news from us:

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

© Copyright 2021 - Particle Measuring Systems is a Spectris company