A Retrospective Analysis of GXP Violations and Observations Emphasized in USFDA Warning Letters Issued to Pharmaceutical Industries

Abstract

This thesis conducts a comprehensive retrospective analysis of GxP violations and newlineobservations highlighted in warning letters issued by the USFDA to Pharmaceutical newlineindustries over the study period from 2010 to 2022. GxP regulations are pivotal for ensuring newlinethe safety, efficacy, and quality of pharmaceutical products. Understanding the implications newlineof GxP violations on the financial performance of Indian pharmaceutical firms, as well as newlineleveraging expert insights for improvement, is essential for sustaining industry growth and newlinemaintaining public trust. newlineThrough a systematic methodology, this study examines USFDA Inspections and newlinewarning letters issued to Indian pharmaceutical companies during the specified timeframe. newlineData has been collected from the USFDA Database and It is categorized based on the GxP newlineviolations and observations across different domains including cGMP, GLP, GALP, GDP newlineand Data Integrity violations. Additionally, it assesses the impact of these warning letters on newlinethe share market value of the respective companies, both upon receipt of the warning letter newlineand after subsequent closeout letters. Utilizing Pareto analysis, the research identifies critical newlineareas of non-compliance that disproportionately contribute to regulatory infractions and newlinefinancial repercussions. Moreover, through a survey conducted among industrial experts, the newlinestudy gathers insights and recommendations for enhancing GxP compliance and mitigating newlineregulatory risks within the Indian pharmaceutical sector newline