An Overview Of Quality Assurance and Quality Control

Author(s)	Vaibhav Ramdas Jadhav, Akanksha Madhukar Purkar, Nikita Santosh Dukale, Bhushan Pravin Gaikwad, Dipali Ramdas Jadhav
Country	India
Abstract	This review offers an overview of Quality Assurance (QA) and Quality Control (QC) in the pharmaceutical industry, highlighting their vital roles in ensuring the safety, efficacy, and reliability of products. QA involves preventing defects and ensuring quality throughout a product’s lifecycle, while QC focuses on identifying and correcting defects through testing. Key regulatory frameworks like Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and International Council for Harmonisation (ICH) guidelines are discussed, along with Good Warehousing Practices (GWP) for storage integrity. The document covers drug discovery and development, validation processes, and the roles of regulatory authorities such as the FDA, WHO, and MHRA. It concludes by introducing Quality by Design (QbD) and Process Analytical Technology (PAT) as methods for embedding quality from the start.
Keywords	Quality Assurance, Quality Control, Safety, WHO, ICH, Efficacy, GLP.
Field	Medical / Pharmacy
Published In	Volume 7, Issue 2, March-April 2025
Published On	2025-03-03
DOI	https://doi.org/10.36948/ijfmr.2025.v07i02.37929
Short DOI	https://doi.org/g86wpw

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