Bridging the Gap Between Regulatory Expectations and Industry Practices in Pharmaceutical Quality Control

Abstract

The pharmaceutical industry operates under stringent regulatory frameworks to ensure the safety, efficacy, and quality of products. Quality Control (QC) is at the core of these efforts, serving as a safeguard against defective or substandard products. However, a persistent gap exists between regulatory expectations and actual industry practices, which can compromise product integrity, regulatory compliance, and, ultimately, patient safety. Addressing these disparities is crucial to improving product quality and fostering confidence among stakeholders. This editorial explores the regulatory landscape, the challenges faced by the industry, and potential strategies to bridge the gap between expectations and practice.