Dear Validation Collegue,
I have a sterile liquid product. It was sterilized using filtration system and filled into vials and ampoule.
Questions.
- Can I reprocess the rejected (particulate reason) filled product?
- Can I top up with 2nd recovery batch and give new batch no. with shortest expiry date?
I honestly think it was a big NO. Perhaps this forum have another Idea coz’ I’ve found this practice was already going on in certain sterile company.
Thanks in advance.