I am currently involved in process validation within a OTC/ VMS (Vitamins, Mineral , Supplement) manufacturing company.
An issues that are encountered were:
- 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?