PLC validation - Periodic Revalidation

Dear all,

Plz confirm the Periodic Revalidation period for PLCs.

Is there any reference given in GAMP - 4 ?

I wouldn’t revalidate the PLC per se, I would look at the entire system.

I would agree with meyert. The PLC forms part of a system or piece of equipment, therefore would only require a review when the system or equipment is to be reviewed.
Hope this is of some help.

[quote=waynem]I would agree with meyert. The PLC forms part of a system or piece of equipment, therefore would only require a review when the system or equipment is to be reviewed.
Hope this is of some help.[/quote]

PLC is a small pat of whole system or equipment.
When U R going to requalify the system or equipment,
PLC will also requalify

Prasad…
Aventis Pharma

I think what Prasad is saying , is correct.

GAMP 5 eliminates the need for revalidation by ensuring the well defined maintenance procedure is in place. The periodic review of the critical aspects of the system and the maintenance activies will replace the need for revalidation effort. The review period can be defined internally based on the criticality of the system.

Could you share GAMP 4/5 guidelines
Warm Regards
Ravindra Upare
upareravindra@rediffmail.com

Hello!

I generally agree with earlier points that PLC/SCADA should be looked as part of overall system and revalidation should be based on that.

However, to be more specific of PLC systems, you need to check whether during regular operations, changes in original configurations have taken place or not. This may be hardware changes or software ( program) changes.

All such changes need to be assessed for risks they portays to existing process from product quality point of view. Based on that a qualitative decision needs to be taken for redoing relevant test if it is of high or medium risk. Otherwise unnecessary testing is to be avoided. However care is always to be taken to document such decisions.

Trust above is of use.

Regards

Jaydeep D. Chhatrapati
Director
Epitome Technologies Pvt. Ltd.
Ahmedabad. India.
Email : jaydeepc@epitome.co.in

Yes i know, the PLC guy
What is the problem with your account?

Dear vamsemicro,

you do not need to revalidate PLC if you have continuous good quality of product at the end of line, system…etc…
Time to time you can make some challenge tests for the machine but it is part of maintenance.

rgds,

cubica:)