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.

Cleanroom Process Risk Assessment: Why it’s important

A process risk assessment helps you 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.

Learn more… Get the full paper here. 

Learn how the PMS Advisory Team can help you with a Cleanroom Process Risk Assessment.