PROCESS VALIDATION OF TERBINAFINE 250MG TABLETS
Keywords:
Heating ventilation and air conditioning system, Standard operating procedures, Validation master plan, Disintegration time, Quality management system, Over the counter, New Drug Application, Quality Assurance, Design Qualification, Operational Qualification, Installation Qualification, Performance Qualification.Abstract
In the present work simultaneous process validation of Terbinafine tablet was completed. Process validation is the mean of guaranteeing and giving narrative confirmation that procedure inside their predefined outline parameter are prepared to do over and over and dependably delivering a completed result of required quality. The procedure approval of Terbinafine HCL tablets of dosage 250mg was completed for 3 back to back bunches of Batch no.1, Batch no.2, Batch no.3 which incorporate the validation of basic strides of assembling constituting apportioning, filtering, Dry blending, Granulation, Drying, Blending, Compression and Packing. Disintegration of the three successive validation clusters were contrasted and the reference test. All previously mentioned process was approved amid the procedure approval. The outcome got of the three clumps were found inside the points of confinement. In this way the item with required particular can be reliably acquired.
