Cell And Gene Therapy – Aseptic Process – Media Fill Failure Investigation Process
The below process flow was created for one of our CGT clients based on a process mapping exercise to help understand that there are numerous lines of investigation that need to be performed immediately once a positive unit is identified during an aseptic process simulation (APS).
This is no normal deviation investigation process and must have it’s own procedure to describe how to expedite the investigations and what would need to be considered in the APS investigation. With such investigations a risk assessment must be performed to consider the risk-benefit on whether to continue with the product in the market or to recall and reject it.
With CGT medicines, it’s the risk to patient that should be the primary consideration.
If your business requires support with CGT aseptic processes, please contact us for a free 60 minute consultation to see how we can help. You can contact us at email@example.com or on +44 (0) 20 7692 5259.
Written by: Sanjay Nadarajah, GMP/GDP Consultant