European Journal of Biomedical and Pharmaceutical Sciences

PROCESS VALIDATION –A REVIEW

Himanshu Paliwal*, Suresh Kumar Purohit and Kamal Singh Rathore

ABSTRACT

Validation is a preeminent constituent of quality assurance scheme of a particular process. Validation is regarded as the requisite component of Good Manufacturing Practices (cGMP).When such a technique is employed in examining each step of manufacturing process; it is referred to as Process Validation. It allows us to ensure that a given pharmaceutical process will produce quality products that meet its predetermined specifications. Process Validation focuses on process design elements and maintaining control over process during commercialization and communicate that process validation is an ongoing program and align process validation activities with product lifecycle. Process Validation also accentuates understanding, identifying and control of variability. Here this article aims to explore the importance of pharmaceutical process validation. The objective is to confer a review and describe objective and principle of process validation, types of validation operations, regulatory basis, validation protocol and master plan and other relevant considerations.

Keywords: Process Validation, cGMP, Qualification, Quality Assurance, Protocol.