Mr Austin Stewart

I am currently involved in process validation within a OTC/ VMS (Vitamins, Mineral , Supplement) manufacturing company.

An issues that are encountered were:

  1. Deviations raised during processing due to spillage of material during first PV batch. The spillage did not impact on the overal yield or quality but identifies a processing issue. The deviation stated that a newThe second and third PV batches were manufactured without the corrective action from this deviation being completed. However, no spillage occurrred during these 2 batches. All results from the 3 batches met the accpetance criteria from a quality perspective.
    To me this process is not validated as it does not show “documented evidence that the process is effective and reproducible…”

Do you think that another batch should validated or what approach should be taken?

Does anyone have any thoughts?

Hi Austin,

If the prcoessing issue is going to changed due to a corrective action then it might be a good idea to repeat the validation study as a part of the process is being changed/improved.

Or perhaps you might want to pass the initial validation and open a revalidation process to ensure theat the process is still working correctly

Just my 2 cents

You are right Mr. Graham, In process validation, the batches manufactured with same formulation and jhaving same parameters, if any change may happen delibrately or accidently,either it may affect of product quality or quanity or not, the validation should be done on same formulation, and any change in actual approved product manufacturing processes, it should be identified deviation record.