Abstract

QUALITY CONTROL AND QUALITY ASSURANCE IN PHARMACEUTICALS INDUSTRY

Dr. Md. Waasiullah, Piyush Yadav* Saksham Yadav and Pragati Singh

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Abstract

In the healthcare and life sciences industries, quality processes like quality assurance (QA) and (QC) are required by the FDA and the International Organization for Standardization’s ISO 9000. If QA and QC aren’t followed, you could end up sending out an end product that not only doesn’t meet standards but could also have life-threatening consequences. Both QA and QC processes are important to quality standards, but so knows the difference between quality assurance and quality control. They’re often used interchangeably, but they are two different processes taking place at different times. Quality assurance and quality control both play vital and distinct roles in the health of life sciences companies and are big parts of quality management. Understanding those roles can help your organization master each to deliver the best products possible.

Keywords: Quality processes, quality control, FDA, QA/ QC, quality assurance.