Process validation

The purpose of research was to study process validation of Azithromycin 250 mg tablet dosage formulation. Tablets were manufactured by wet granulation method. The critical parameters involved in sifting, dry mixing, wet granulation, drying, dry milling, lubrication, compression and coating stages were identified and evaluated as per validation master plan. Uniformity of dry mixing was found to be satisfactory in 15min. For suitable wet mass consistency, slow speed of impeller was maintained during the addition of binder solution for 10 min which was followed by high speed of impeller for 20 min. Drying time of 1 hour was sufficient to achieve % Loss on drying up to 1.5-2%w/w. Uncoated azithromycin tablets were collected at different speeds and different stages and evaluated for their appearance, average weight, diameter, thickness, disintegration time, hardness, friability and assay. Film coating was performed in auto coater and film coated tablets were evaluated for appearance, average weight, diameter, thickness, disintegration time, hardness, friability, dissolution test and assay. Based on results, it can be concluded that Azithromycin tablets can be effectively prepared with the desired specifications and reproducible quality standards.  The outcome indicated that process validation data provides high degree of assurance that manufacturing process produces product meeting its predetermined specifications and quality attributes.