Blog

Alarms: Can they be considered as batch release parameters?

Written by Gerardo Vece | Dec 19, 2022 11:00:00 PM

Alarms are an integral part of pharmaceutical processes and, as is often the case, can have an impact on the outcomes of our processes, so the question arises: can alarms be considered as a relevant aspect of batch release? 

When we release a batch, we make sure that everything that may have an impact on the quality of the product is in compliance by conducting a periodic evaluation of the data to determine the limits within which our process can move in order to understand whether it is centered and under control. 

After this brief introduction, we move on to analyze alarm management, starting with what is stated in Annex 1

“Process and equipment alarm events should be acknowledged and evaluated for trends. The frequency at which alarms are assessed should be based on their criticality (with critical alarms reviewed immediately).”