DETAILED NOTES ON DOCUMENTATION SYSTEMS IN PHARMA

1.      Batch production data really should be organized for every intermediate and API and may include things like entire information and facts relating to the production and Charge of Every batch. The batch production record ought to be checked before issuance to guarantee that it's the right version in addition to a legible precise reproduc

After 7 days of incubation notice the vials for any microbial contamination and record the observation.Unit accountability and reconciliation shall be managed and documented just before and right after Every single inspection time period.An analysis of all the research versus the protocol needs as outlined higher than really should be ready and als