Process validation

Dear All

I am having the validated process for a product & now i want to remove the overages based on the stability study. if we need to do the process validation again or not. My equipment in the process remains the same.

Hello Anup,
The revalidation of process is required if you are changing process parameters or something which directly related to process (i.e. changing raw material, operating conditions).
once the process validation for three batches is done, anything change in process is not acceptable…

Dear Prasant

I am having the stability data that overages is not required.

Now after removal shall i do process validation again.

regarding to compression step of tablet process validation, should we perform the content uniformity though it meets the requirement for weight variation? sometimes weight variation could not reflect the content of uniformity. in my opinion, weight variation could be used when justified and authorized.

in homogenous system, ie true solution, when it contains more than one API, could we use marker compounds in order to determine the uniformity? the marker compound(s) is the lowest solubility and/or the lowest quantity.

thanks in advance.

Hello Anup,
Can you please tell me what are the overedges you are calling ?
If they are not part of process validation and not affect the process. i think you can remove and no need to revalidate the process.
With good understanding of process and it’s influence on the process and with scientific justification you can defend auditor successfully …

all the best…

Please check the quanity of overages against the batch quanity and make risk assesment for the same. Evaluate the risk involved in validation status.
If the quanity is very less, based on risk assesment no need to do revalidation. Still if you have bit doubt, you can confirm the same with one batch valiadtion as per PVP and compare with previousvalidation batches.Keep the batch for stability. You can refer SUPAC IR guideline also.

Dear Anup
There is no requirement of process validation if u remove the overages with respect to reduce specification limit i.e. assay limit.
If u do not changes the assay limit then u trigger the validation on removing overages.

could you please send me information about any document that mentions we could not change the source of raw material, especially the API, during process validation? in other words, we should revalidate if we change the source of raw material. thanks in advance.