Journal of Pharmacovigilance and Quality Assurance ISSN: 3108-2343 (Online)

Authors: Dr. Priya Malhotra, Mr. Ankit Verma

ABSTRACT: Pharmaceutical regulatory inspections are critical tools for ensuring compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP). Regulatory bodies such as the US FDA, EMA, and CDSCO conduct routine and for-cause inspections to verify that pharmaceutical organizations adhere to established quality, safety, and efficacy standards. This paper explores the principles, methodologies, and challenges of regulatory inspections and compliance in the pharmaceutical industry. Emphasis is placed on inspection types, preparation strategies, common findings, and corrective actions. Tables summarizing inspection processes, key compliance areas, and mitigation strategies are included. Effective regulatory compliance enhances patient safety, product quality, and global market access.

KEYWORDS: Regulatory Inspections, Pharmaceutical Compliance, GMP, GCP, GLP, Quality Assurance, Drug Safety