+39 06 9053 0130

Cleanroom Process Risk Assessment per Annex 1

Written by

In the final part of our five part series of Quality Risk Management per Annex 1, we explore the benefits of a Cleanroom Process Risk Assessment and how our Contamination Control Advisers can provide you with one.

Process Risk Assessment: Why it’s important

A process risk assessment helps you to to ensure risks are properly controlled. Without a risk analysis:

  • you may have too many or too few sampling points.
  • You may not be able to correlate the data with the operations
  • The data may not be usable in the case of an investigation or trend analysis to define alert and action levels
  • There may not be a correlation between the positioning of the particle counters and the active air samplers
  • The particle counters could be disturbed by movement of machinery during operations
  • The heights may not be properly defined

While the final wording of EU Annex 1 is not yet released, the message is clear: European health authorities and inspectors will seek scientifically sound, unbiased risk assessments, and the use of QRM principles in the planning, design, control, monitoring, operation, and investigation of sterile product manufacturing processes. The industry must be prepared to develop and employ those QRM principles and risk management methods.

Cleanroom Process Risk AssessmentLearn how our Advisory Services Team can help you with a Cleanroom Process Risk Assessment.

Want to read more? Jump to other released posts in this series:

 See links to additional supporting resources below: 

Don’t miss an episode of this series. Register for updates on the right column of this page. Click here to contact our Experts for questions.