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Annex 1 Latest Draft Revision Updates

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)
  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.

    read all

  • 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.

     

     

    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

  • 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?

    read all

Annex 1 Compliant Particle Counters

  • cleanroom microbial monitor

    Microbial Monitor: BioCapt® Single-Use

    This cleanroom microbial monitor is an innovative replacement for settle plates, provides 2 hr sampling, and minimizes false positives, resulting in a decrease in investigations.

  • Portable Particle Counter: Lasair® III

    Sets the standard for portable aerosol particle counters and meets the requirements of ISO 14644-1:2015 and ISO 21501-4.

  • 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 by Particle Measuring Systems (PMS)

    MiniCapt® Mobile Microbial Air Sampler

    The innovative microbial air sampler. ISO 14698:2003 compliant

  • PharmaIntegrity

    PharmaIntegrity Data Integrity

    Creates a complete contamination monitoring solution for pharmaceutical manufacturers.

Get a Quote

On Demand Webinar re: Annex 1 Draft, Rev 12

Viable Monitoring Solutions to Prepare Your Contamination Control Strategy (CCS) for ANNEX 1

The New Annex 1 draft (rev 12) has some critical changes that are important to understand and start applying. While the drafts cover many areas of environmental monitoring in-depth, this webinar by Particle Measuring Systems’ (PMS) experts focuses on the Viable/ Microbial Air Monitoring aspects.

  • Dr. Frank PanofenPresenter

    Dr. Frank Panofen

    PhD, Life Science Division, Product Line Manager Microbials, Particle Measuring Systems
  • Presenter

    Dra. Giulia Artalli

    Gerente Global de Linha de Produtos, Particle Measuring Systems
  • Presenter

    Paola Lazzeri

    EMEA Field Application Specialist Sterility Assurance/Microbiology, Particle Measuring Systems
WATCH NOW

On Demand Webinar

The New EU GMP Annex 1 Revisions 2017: Review, Insights, and Feedback

Download this webinar to learn about the new draft of the EU GMP Annex 1:2017 and what these changes might mean for you.

  • Dr. Frank PanofenPresenter

    Dr. Frank Panofen

    PhD, Life Science Division, Product Line Manager Microbials, Particle Measuring Systems
  • Daniele PandolfiPresenter

    Daniele Pandolfi

    Global Product Line Manager, Aerosol, Particle Measuring Systems
  • Presenter

    Gilberto Dalmaso

    Global Life Science Scientific Officer
Download Now

Ask a Question

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

Ask Your Question

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Keep in touch! Receive industry news from us:

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • Molecular Monitors
  • BioCapt®Certificates of Analysis
  • 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

  • Knowledge Center

About Us

  • COBE
  • Contact Particle Measuring Systems

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9630 Wattwil, Switzerland

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

Keep in touch! Receive industry news from us:

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