Abstract

INTRODUCTION TO QUALITY ASSURANCE AND QUALITY CONTROL

Shubhada S. Pawar, Sanjay K. Bais and Vighnesh Nagnath Putta*

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Abstract

The purpose of quality assurance in the pharmaceutical supply chain is to guarantee that every medication that is given to a patient is safe, efficient, and of a suitable calibre. Although thorough program of quality assurance consists both administrative and technical tasks. One crucial function of the pharmaceutical sector is quality control. It might also carry out a statistical analysis of the test findings to demonstrate the reproducibility of the procedure. In order to determine how successful its test program has been in keeping rejectable products off the market, it examines the product complaints. Due to national and international requirements, it is now required to disclose not just the purity profile, in addition to the profile of an impurity of specific pharmaceutical drug product. These elements are explored together with the importance of the efficacy, safety, and quality of drug, as well as the types, sources, and controls of impurities as well as regulatory issues. Among the requirements regarding the implementation of the any nation's medical system is the availability of the necessary medications of high quality, since subpar medications have the potential to cause harm or even death to patients. Even in minute amounts, the presence of undesirable compounds in a specific medication may have an impact on its effectiveness & safety. A pharmaceutical is a dynamic product, unlike those in other sectors, whose changes can occur in colour, consistency, weight, and even chemical identity between the moment of creation and the moment of final consumption.

Keywords: Quality Assurance, Quality Control, Difference between QA & QC.