suppose we have two granulation area and both have same capacity equipment and we validated a product on one granulation area? is there any need to done validation in second granulation area as they have same equipment with same capacity and model
If there is same capacity equipment with same make, that means the equipment equivalency is same. So there is no requirement of validated same product which having same parameters.
THANX FOR REPLY SIR
can we proceed for the same if we have same capacity equipment but have different make and model with different operating procedure. i.e. SOP
DR REDDYS LABS
please refere SUPAC guidelines. This refers to Level 1 change and there are certain documenation practices required before you take a batch on the equipment of what you described.
you have to prepare equipment equivalency report and prove that both the equipments are working under same principle. if need you can get the certificate from the vendor.Then no need to go for validation.Prepare one addendum to the old process validation report to include the new equipments and can conclude the process remains in validated status