AN OVERVIEW OF INDUSTRIAL PROCESS VALIDATION OF TABLETS
Chandan Sharma, A. C. Rana, Rajni Bala, Nimrata Seth · Journal of Drug Delivery and Therapeutics · 2013
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, in-process and end-product testing. Process validation is 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. Keywords: Quality, process variables, process validation, guidelines.