Process validation of diazepam in pharmaceutical dosage form

Abstract

Validation is an integral part of cGMP. It is one of the most important part of quality assurance. The purpose of this research investigation was to study Retrospective Process validation as well as Concurrent Process validation of Diazepam Tablet. Quality cannot be adequately assured by in-process and finished product testing but it should be built into the various stages of manufacturing process. These manufacturing process with various manufacturing steps including various critical process parameters should be controlled in order to obtain finished product which meets all quality specifications. The critical process parameters were identified and evaluated by performing various tests at different stages. For Retrospective Process validation, 20 batches of same size were taken and the data of various evaluation test like weight variation, hardness, thickness, friability, disintegration, dissolution and content uniformity are compared in order that finished product meet all the specifications under the acceptance criteria. For Concurrent Process Validation, Three consecutive process validation batches of same size, method and validation criteria were taken. All the instruments were calibrated as per standard operating procedures. The critical parameter involved in the process like sifting, mixing, granulation, drying, lubrication, compression were identified and evaluated. Uniformity of blend result, Assay of drug in tablet, Uniformity of dosage unit and Dissolution study were acceptable. The outcome indicates that this process validation data provides high degree of assurance that manufacturing process produces product meeting its predetermined specifications and quality attributes. So, manufacturing process of Diazepam tablet is considered as validated.