Nitish Maini, Saroj Jain, Satish Sardana

Abstract

Drugs are critical elements in health care. They 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. In pharmaceutical industry, process validation performs this task, ensuring that the process does what it purports to do. Validation is one of the important steps in achieving and maintaining the quality of the final product. If each step of production process is validated we can assure that the final product is of the best quality. This paper presents an introduction and general overview on process validation of pharmaceutical manufacturing process of liquid lyophillized formulation with special reference to the requirements stipulated by the United States Food and Drug Administration (USFDA).