Abstract

A BRIEF REVIEW ON PHARMACEUTICAL VALIDATION AND PHARMACEUTICAL PROCESS VALIDATION

Sumesh B. Waghmare*, Sidheshwar S. Patil, Raviraj R. More, Rahul S. Solunke, Sharad V. Usnale and Vidya S. Jadhav

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Abstract

Validation is one of the crucial processes in establishing and maintaining the final product's quality. We can ensure that the final product is of the highest quality if every stage of the production process is checked. The art of validation involves planning and carrying out the planned actions while also documenting them. Validation and quality control work together to guarantee the items' full quality. Process validation emphasises process design components and maintaining process control during commercialization. It also makes clear that it is an ongoing programme and synchronizes process validation operations with the lifecycle of the product. This article provides a general introduction to pharmaceutical validation in the pharmaceutical manufacturing process as well as an outline of its significance.

Keywords: Pharmaceutical Validation, Process Validation, Prospective Validation, Retrospective Validation, Concurrent Validation, Re-Validation.