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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.

 

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Particle Measuring Systems Nordic
Korskildelund 4-6
2670 Greve, Denmark

T. +45 7070 2855
[email protected]

Keep in touch! Receive industry news from us:

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • BioCapt®Certificates of Analysis
  • Compressed Gases Particle Counters
  • Molecular Monitors
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Photonics & Optics
  • Aerospace
  • Industrial Manufacturing

Applications

  • ISO 21501-4
  • Parts Cleanliness Testing
  • Annex 1 Latest Draft Revision Updates

Service & Support

  • Advisory Service
  • Product Calibration and Service
  • Customer Service

Education and Training

  • Knowledge Center
  • Software / Data Management
  • Contamination Monitoring Blog

About Us

  • Contact Us
  • Why PMS
  • Executives
  • Particle Measuring Systems’ Careers
  • Corporate Responsibility
  • COBE
  • Parent Company
  • Press Releases
  • Credibility & Registrations
  • Trademarks & Patents

Particle Measuring Systems- DK

Particle Measuring Systems Nordic
Korskildelund 4-6
2670 Greve, Denmark

T. +45 7070 2855
[email protected]

Keep in touch! Receive industry news from us:

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