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

Paper: Industry experts answer over 40 common Annex 1 draft questions. 

Topics in this paper include:

  • Classification and Qualification
  • Particle Monitoring
  • Microbial Monitoring
  • Tubing and Filters
  • Risk Assessment

Examples of the questions include: 

  • During cleanroom classification, is it mandatory to monitor viable and non-viable counts simultaneously?
    • Answer: Cleanroom classification is based solely on inert particle counts. For “in operation” qualification, viable and “non viables” need to be sampled. There is no need to do this concurrently, but “non viables” are in effect already sampled continuously, so they are likely monitored at the same time.
  • Can you choose not to use one of the microbiological sampling methods for qualification of a classified area?
    • Answer: Yes, but this will be very difficult to do for microbiological qualification of the room, as all contamination conduits (i.e., air, surface and personnel) contribute to overall cleanroom contamination. Consider using validated alternative methods where possible instead, which will vary based on the parameters of the sampling point and be left up to the manufacturer. Afterwards, when determining the monitoring strategy of the sampling point, choose the method that provides the most scientifically reliable data with actionable results.
  • Have particle sizes greater than 5.0 been removed as a requirement of Grade A or B monitoring?
    • Answer: The limit level for particles equal to or greater than 5.0 μm has been removed from the table. However, this size is still required to be controlled during cleanroom monitoring activities.

Get complete 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.