Industrial Process Validation of Tablet Dosage Form: a Review

The present article gives an introduction and general overview on process validation of pharmaceutical manufacturing process especially tablet manufacturing process. The principal objective of dosage form design is to achieve a predictable therapeutic response to a drug included in a formulation which is capable of large scale manufacture with reproducible product quality. Solid dosage forms include tablets and capsules. Quality is always an imperative prerequisite when we consider any product. Therefore, drugs must be manufactured to the highest quality levels. Process Validation is one of the important steps in achieving and maintaining the quality of final product. Process validation also emphasizes the role of objective measures and statistical tools & analyses and emphasizes knowledge, detection, and control of variability and gives assurance on consistent of quality/productivity throughout life cycle of product. This overview examines the need for pharmaceutical validation, the various approaches and steps involved.