Process Validation for Famciclovir

Abstract

The project entitled "Process validation of Famciclovir 500 mg Tablets" was carried out at Macleods
Pharmaceuticals as the validation batch met the specification of tablets. Process validation study on three
consecutive batches, Batch No. A, B,and C of Famciclovir 500 mg. Tablets having batch size of 112500 tablets was
successfully completed and the manufacturing critical process parameters were validated of this transferred product
to show that the process was under control. The study includes the validation of critical steps of manufacturing such
as blending, compression, coating and container packing. It shall also establish the suitability of equipments and area
used for the production. The process of manufacturing was carried as per the approved batch manufacturing card.
The all process validation batches had been manufactured and validated in full compliance with cGMP requirement.