Abstract

PROCESS PERFORMANANCE QUALIFICATION (AN EFFECTIVE TOOL TO ENSURE PRODUCT QUALITY AND PATIENT SAFETY)

*Suvidha J. Mishra, Sweta Goel, Dr. Kapil Joshi and Dr. Mojahid Ul Islam

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Abstract

Pharmaceutical Process Performance Qualification is establishing documented tool of quality assurance which delivers high level of confidence and assurance of that a products meeting its standard specifications and predetermined quality attributes. Process Performance Qualification is mainly emphasise on quality in Pharmaceutical manufacturing process, Equipment system, software and analytical testing methods. According to FDA guideline Process Validation is essential approach to transfer a product from development to commercialization. Process Validation is moreover emphasizes on study of Critical quality attribute, Critical process parameter, objective measures, statistical tool, and graphical method, cleaning protocol, risk assessment and control variability to gives assurance on quality compliance to consistent productivity throughout the product lifecycle. This article represent a basic fundamental concept of Process performance qualification, approaches for validation, general outline and overview on Pharmaceuticals Process Performance Qualification of Products.

Keywords: FDA, GMPs, Quality Assurance, Process Performance Qualification, Control variables.