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.
