If any new product in introduced then process validation is done . My query is that after 1st time process validation, is process validation is done at a regular frequency (2 or 5 year) or is it done only one time when a product is introduced.
Process validation (prospective validation ) to be done when a new process is introduced in the system. There is any major changes(like raw material change or QQF change) are Existed in existing process or process steps then process validation shall be done.
revalidation should be b done after defined period of time.
As per the current guideline PDA Technical report No. 60
Process validation lifecycle approach …you can conduct continued process verification (stage 3) by CPV monitoring plan.
We conduct 10 batches for continued process verification (stage 3) and result of Assay found within limit but results not attain 3 sigma limit
then what next step