Process Validation of Tablet Dosage Form With Risk Assessment Study
Purvi Patel,Rikin Patel*, DharaRathod

Department of Quality assurance, Parul Institute of Pharmacy, Vadodara, India

Product quality is the mainstay of pharmaceutical industries and is derived from careful attention to a number of factors including selection of quality parts and materials, adequate product and manufacturing process design, control of the process variables, inprocess and end-product testing. Process validation and risk assessment study are an integral part of quality assurance program in industries. By validating each step of production process we can assure that the final product is of best quality. This review provides information on objectives and benefits of process validation, types of process validation, major phases in validation and regulatory aspects. Guidelines and strategy for process validation of solid dosage form are also discussed andto minimize the errors and deviations of set quality attributes, avoiding rejections / minimizing rejections. Quality cannot be adequately assured by in process and finished product testing. It should be built into the various stages of manufacturing process. Risk assessment was done in order to minimize failure mode. During risk assessment, failure modes were identified, analysed and evaluated by setting current control.

[Full Text PDF]