Neetu Dubey, Himanshu Gupta, R.K. Sharma, Nitin Dubey, Nidhi Dubey

Abstract

Pharmaceutical industry is amongst most astringently regulated manufacturing units. Quality management system affects the ultimate quality of the finished product. The article represents and explains the current thinking and harmonized guideline of pharmaceutical regulatory authorities with especial reference to United States food and drug administration. The understanding and implementation of appropriate quality management system model enables a pharmaceutical organization to fulfil its ethical as well as regulatory responsibility of including management of identity, quality, safety, purity and efficacy of finished medicinal product. It makes good business sense.