Prospective Validation of Tablet Manufacturing Process of Orodispersible Tablets by Direct Compression

Abstract

Validation of product should be performed as per the protocol. The protocol describes the process stages, control variables & measuring responses with justification, sampling plan, acceptance criteria, summary& conclusion. During the validation, samples were withdrawn according to sampling plan. The manufacturing of orodispersible carbamazepine tablet 100 mg by direct compression was validated successfully considering the following parameters. Mixing performed in a planetary mixture for 5, 10 and 15 min at slow speed. Mix blend were sifted through 40 mesh sieve using vibratory sifter. Compression was performed on a 12 station compression machine at 13, 18, 22, 28 RPM. All the analytical data derived during process validation of carbamazepine 100 mg tablet. Hence the process is validated.