Process Re-validation issues

Dear Forum,

I have few basic queries about process validation approach (biotech). I think this forum is best place to get the answers. My questions are:

  1. Should we re-validate the whole process if only one step has
    changed? If yes, what should be approach for re-validation? Single step re-validation?All steps re-validation?

  2. Impact of Multiple equipments on validation -should we validate
    using each (like to like) equipment? How to address change of equipment?

  3. Impact of scale up on validation - do we always need to repeat?
    How much to we need to repeat?

Please guide me what is generally accepted practice? Guidelines?

Thanks in advance.

Arvind K

Step 1: write a Master Validation Plan (or Validation Master Plan if you prefer)

Step 2: address all the points you raise in the Plan.

Ok, that was a bit tongue-in-cheek so let me elaborate a bit.

Nobody can tell you whether or how much you need to validate if you change one step in the process. That’s got to be determined by a risk-based analysis. Your MVP / VMP should describe the process you go through to assess the risk and determine your re-validation requirements. If the step is reasonably isolated with minimal potential for impact on quality and the result is normally readily verified, then probably very little re-validation is necessary. Your analysis should be documented.

For item 2, again, you need to assess the risk. I think in general, an IQ is performed for each piece of equipment installed and then a (possibly modified / scaled down) PQ is executed.

For item 3, I’m guessing you’re talking about scaling production up? If that’s the case, I would think you would either originally qualify your equipment to the range of anticipated operation or execute another PQ at the increased rate to confirm you can sustain quality at that rate for the given run time.

Again, address these things in an MVP/VMP then document your decisions with all appropriate rationale. Otherwise, you’ll likely be cited for failure to adequately control your processes.