An Overview of Pharmaceutical Process Validation of Solid Dosage Form.

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. This article covers Introduction, type of validation ,Prospective validation Retrospective validation Concurrent validation Revalidation ,Elements of Process Validation, Product Lifecycle View ,Phases of Process Validation , Rationale for selection of critical steps and parameters for process validation, Documentation ,SOP, Validation Master Plan, Validation Protocol, General notes process variations, critical factors and sample thief ,sampling plan and acceptance criteria, the validation report, studies on the process validation by all these parameter highlight the quality output of finished dosage form.