Hi,
My company is going to use online monitoring system for our productions process room. It can only monitor RH, Temperature and differential pressure for every rooms. Thus, it will give notification through SMS and email if any OOS happens. IQOQ will be conducted by vendor based on the documents provided by them. It focuses on hardware of the data loggers and the software.
The question is, how do we conduct PQ for this online monitoring system? Can we conduct the PQ by monitoring the performance of the system i.e. the alarm, the notifications sent to respective users, and by examining the data recorded throughout the PQ? How long should we monitor the performance of this system? Can we use the approach of WHO water system qualification, like Phase 1, 2 & 3 for monitoring the system?
Thank you.
You have another problem. Is RH, temperature, differential pressure a CPP (critical processing parameter). In short do these factors affect your drug product and how? Ongoing monitoring means you monitoring your CPPs and CQAs (critical quality attributes).
Is this a case of ‘fire, ready, aim’?
Hi.thank you for the reply.yes,those 3 factors are the CPPs that will affect our products. We closely monitor those CPPs during our products manufacturing.
Sorry I’m not clear on your ‘fire, ready, aim’ case.
We just want to know on what type of tests should we perform for PQ for this system.
Thank you.
Be sure all these instruments are in calibration and monitored based on your risk assessment. As always, keep a trend analysis (daily) of your specifications and lots (QA already does this for the annual product review).
Most places get it backwards so instead of ‘Ready, Aim, Fire (Shoot)’ it is ‘Fire, Ready, Aim’.
Thank you sir for your reply. Really appreciate it.
Now we know what should we do.
Thanks again
There really isn’t a PQ for a monitoring system. It has already been tested in the OQ.
If so, what can u suggest since we are required to do so.
If so, what can you suggest since we are required to do so.
Usually, at each ‘Point of Use’ you demonstrate that you can make USP water (purified water or water for injection) per their specification. The EU has something similar.