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Annex 1 Insights & Updates

The European Commission released their Annex draft for review and comment. Our experts have reviewed this document carefully and have shared their insights with you.

Here are some quick video snippets Particle Measuring Systems’ experts have put together on single topics covered by Annex 1 Rev 12 2020:

  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)View Page
  7. Science v. Standardization: Meeting auditor’s expectations by understanding the reasoning behind the rules
  8. Using a Risk Assessment to set microbiological plate incubation conditions
  9. Microbiological Plate Incubation
  10. Data Trending-Alert/Action Level Settings 

Stay tuned for more spinets or get a summary of the EU GMP Annex 1 Draft Revisions by reading the paper below or watching the on-demand webinar at the right. We also have FAQs with answers below.  Also, scroll to the bottom for some of our Annex 1 compliant viable non viable instruments and data management solutions.

Annex 1 Insights: Knowledge / Papers

  • EU Annex 1:Impact on Environmental Monitoring for Clean Manufacturing

    On December 20th, the first draft for a Revision of EU ANNEX 1 was published for public comment. Particle Measuring Systems put together a team of industry experts to provide their insights of the new aspects of environmental monitoring in sterile manufacturing and its probably implications to Pharmaceutical manufacturers.

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  • Annex 1 Revision 2017 Comments from Industry Experts

    The updated EU GMP Annex 1 Draft was released for public comment in December 2017, and the industry experts at Particle Measuring Systems have shared their response on the revision.

     

     

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  • 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.

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  • Concerned about how Annex 1 might affect you?  

    Industry experts answer over 40 common Annex 1 draft 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?

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