A Review on process validation of solid dosage form

Abstract

Objective: The purpose of this work is to perform a study on concurrent validation of levonorgestrel tablet BP 0.03mg that will deliver process validation approach as a quality assurance means. The process validation program will be investigated so that the plan will be designed to the character of the procedure under study. This can be performed by checking and controlling the various critical in process parameters.
 Method: The samples from the three consecutive batches of levonorgestrel tablet 0.03mg are collected at the different stages of the manufacturing from dispensing, mixing, granulation process, drying process, blending process, compression process. Each and every parameter are analyzed and tested as per the specifications and all the data are recorded. The obtained results must be within the specified limit range.
 Result: The results obtained from the evaluation of different parameters like bulk density, tapped density, friability, hardness, weight variation, and assay were found to be within specification limit range.
 Conclusion: The conclusion of the concurrent process validation of levonorgestrel tablet BP 0.03mg is based on the result of the validation data of three consecutive batches. It is concluded that the manufacturing process used for levonorgestrel consistently producing the stable product meeting it is predetermined specification and quality attributes.
 Keywords: Concurrent process validation, Process validation, Levonorgestrel, Critical process parameter.