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The New EU GMP Annex 1 Revision 2017 FAQ

Confused about the Annex 1 draft proposed changes how they might affect you?  

Our experts answer over 40 common questions including:

  • During cleanroom classification, is it mandatory to monitor viable and non-viable counts simultaneously?
  • Can you choose not to use one of the microbiological sampling methods for qualification of a classified area?
  • Does the removal of the 5 micron particle size from ISO 14644 mean the qualification time for Grade A and B will be vastly reduced?
  • Have particle sizes greater than 5.0 been removed as a requirement of Grade A or B monitoring?

Get answers to these and other questions by filling out the form and downloading the paper. If you can’t find the answer to your question, the contact information for an Annex 1 expert is included at the end of the paper.  

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Products

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

Industries

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

Applications

  • ISO 21501-4
  • USP 788
  • Parts Cleanliness Testing
  • EU GMP Annex 1

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  • Product Calibration and Service
  • Customer Service

Education and Training

  • Knowledge Center
  • Software / Data Management
  • Blog

About Us

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  • Why PMS
  • Executives
  • Careers
  • Corporate Responsibility
  • COBE
  • Parent Company
  • Press Releases
  • Credibility & Registrations
  • Trademarks & Patents

Particle Measuring Systems

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