Quality Assurance

Drug Development
Harjinder Brar

Harjinder Brar

Apotex Inc., Toronto, ON, Canada

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Jude Vethanayagam

Jude Vethanayagam

Apotex Inc., Toronto, ON, Canada

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First published: 27 April 2021

Abstract

Quality assurance in pharmaceutical manufacturing, quite simply, is the sum total of processes, practices, and systems utilized to ensure the SISPQ (safety, identity, strength, purity, and quality) of a medicinal drug intended for a patient. A robust quality management system (QMS) ensures this by adhering to the regulatory guidance and industry best practices where these practices are occurring, as well as by ensuring drugs meet the regulatory requirements for the different intended markets. The intent of this primer on quality assurance is to provide the interested reader a foundation for appreciating the requirements, complexity, and care that goes into managing the safe delivery of effective medicines to patients.

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