Critical Variables Monitoring during Process Validation

[ifserav]

Hi to everibody?

During the process validation, it muss have to be manitoring the critical variles of the process, so it can it be done with the instrument of the equipment or it is necessary to take lectures with an extra instruments?

Thanks in advance

Sergio ?vila

 

[v9991]

(as i understand your question is to deal with critical variables and its precision and accuracy)

in short and brief.....generally speaking...

process validation is not to do extra-additional measurement of critical variables. any efforts in ensuring the correctness-precision-accuracy of the critical variables is an pre-validation exercise. (PV is not challenge the precision and accuracy of an temperature probe or an timer!!!)

PV is mainly to do that extra&additional measurement of quality attributes, such that, the data demonstrates the confidence and reproducible of the process. in order to do that, we might draw additional samples for analysis of CQAs and analyze to generate required data.


now
in the context of quality by design, we tend to treat certain inprocess parameters as critical variables, in such case, it might be relevant, but i guess that is out of scope for now!!! (neither QbD and nor new-Process validation guideline have yet come into force...ie.., become an audit agenda etc., wrt regulatory enforcement...)

still, if that is what you are looking, for...then the ans is little different...
here are few quick discussions....but not focussed on overall new-PV guidance etc.,
Process Validation Protocol (API) as per new FDA Guidelines
Sampling Plans - Guidance to Sampling a Process during Validation

but here's where we look forward to hear little more specifics/examples to respond more precisely...

hope that it helps...

 

[Ajit Basrur]

Hi to everibody?

During the process validation, it muss have to be manitoring the critical variles of the process, so it can it be done with the instrument of the equipment or it is necessary to take lectures with an extra instruments?

Thanks in advance

Sergio ?vila

Can you tell us the product so that more specific answers could be obtained ?

 

[ifserav]

Hi

It?s a welding process, a part of the entire process. but i made the quetion because in the autoclave validation, it have to use a reference bath .

 

[v9991]

I was re-reading your query......

so to give an example of your query......once a (timer or temperature probe) on a equipment is qualified should we use an additional/external reference/standard for verifying the performance of process.

see if the following clarification with example helps...

general ans is NO.
(there are exceptions which are product or dosage form specific.
viz., during sterilization (dry / steam)...
*) first we calibrate the simulated autoclave for its performance;
*) but similar/same conditions have to be established when running a validation cycle on a specific product.
*) (note here, that conditions prevailing in the autoclave are specific to product , pack, load, configuration etc.,)

in case of autoclave sterilization process....
its required to have temperature mapping using external probes (this is to identify the hot and cold spots which will be specific to the product-pack-configuration etc.,)

regulatory submission expectations do reflect similar logic...
Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products

A summary should consist of, for example,high and low temperatures (range), average temperature during
the dwell period, minimum and maximum F0 values, dwell time, rundate and time, and identification of the autoclave(s) used. These data should have been generated from studies carried out in production autoclave(s) that will be used for sterilization of the roduct that is the subject of the application.

other usefull references @
http://www.ch2m-idcfs.com/Papers/IDC2002 autoclave.pdf

hope this helps...