Abstract

PROCESS VALIDATION: AN ESSENTIAL PROCESS IN PHARMACEUTICAL INDUSTRY

P. Vijayasree*, T. Kalyani, K. Mohan Rao, Brahmaiah Bonthagarala, M.V. Nagabhushanam and P. Seetharamaiah

ABSTRACT

The purpose of this work is to present an introduction and general overview on process validation of pharmaceutical manufacturing process especially tablet manufacturing process with special reference to the requirements stipulated by the US Food and Drug Administration (FDA). Quality is always an imperative prerequisite when we consider any product. Therefore, drugs must be manufactured to the highest quality levels. End-product testing by itself does not guarantee the quality of the product. Quality assurance techniques must be used to build the quality into the product at every step and not just tested for at the end. In pharmaceutical industry, Process Validation performs this task to build the quality into the product because according to ISO 9000:2000, it had proven to be an important tool for quality management of pharmaceuticals.

Keywords: Process validation, Quality Assurance, Quality, Pharmaceutical industry.