Clarithromycin Immediate Release Tablet. Formulation and Process Validation

      Аннотация: Quality cannot be assured only by doing finished product testing and in-process monitoring; it should be built into the manufacturing process. As a result, quality construction necessitates special attention to a few factors such as material selection, process design, control variables, in-process control, and finished product testing.In this study, three initial batches of Clarithromycin tablets with the same size, method, equipment, and validation criteria were taken. Various critical parameters during dry mixing, wet granulation, drying, lubrication, and compression were identified and evaluated as per the validation protocol. The results of the whole process show that process validation data gives a high level of confidence that the manufacturing process will produce a product that meets its predetermined specification and quality attributes.

Ключевые слова: Process validation, immediate release tablet, Clarithromycin