EU GMP Annex 1—Impact on Air Monitoring Program for Medical Devices Manufacturers

Annex 1 of the European Union’s Good Manufacturing Practices (GMP) provides guidance on the sterile manufacture of medicinal products. These guidelines went through revisions for several years and were finalized as of August 2022. 

The changes are intended to ensure consistent product quality and reduce overall manufacturing costs. Part of the focus is on the importance of a contamination control strategy in cleanroom design and qualification, environmental monitoring, and several other areas.


Here, our own Eric Clement Arakel, Global Product Manager, and Myriam Gueye, Segment Marketing Manager, Applied Industries at Sartorius, explain how the newest form of the guidance impacts air monitoring for both medical device and pharmaceutical manufacturers.

Page Count: 4
Read Time: 5 minutes
Last Updated: September - October 2022
Author: Med-Tech Innovation News
Target Audience: People working in QC Labs, R&D Design, Validation, Manufacturing, Clinical Study, Biocompatibility, 3D Printing, sterilization
Applications Covered: EU GMP Annex 1, Quality Risk Management and Contamination Control Strategy, Non-sterile manufacturing, Monitoring cleanrooms

Key Takeaways

  1. The Annex 1 contains several major revisions with many references to the implementation of Quality Risk Management.
  2. The manufacture of sterile products should be carried out in appropriate cleanrooms, making environmental monitor¬ing of viable particles and cleanroom qualification essential.
  3. A combination of different methods, contact plates, settle plates, and volumetric air sampling is recommended.
  4. All Grade A monitoring must be continuous and capture the entire duration of operation.

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