Ensuring Compliance with FDA Regulations in the Pharmaceutical Industry

EasyChair Preprint no. 13669

Abstract

The pharmaceutical industry operates under a stringent regulatory framework to ensure the safety, efficacy, and quality of medicinal products. The U.S. Food and Drug Administration (FDA) plays a pivotal role in this ecosystem, setting and enforcing standards that safeguard public health. This comprehensive article delves into the historical evolution of FDA regulations, key regulatory guidelines, compliance strategies for pharmaceutical companies, the role of technology in enhancing compliance, and case studies that highlight both successful compliance and the consequences of regulatory breaches. Additionally, it explores future trends in pharmaceutical regulation, including the challenges posed by personalized medicine and globalization. Through a thorough examination of these aspects, this article aims to provide a holistic understanding of FDA compliance and its critical importance in the pharmaceutical industry.

Keyphrases: Drug approval process, Electronic record keeping, FDA regulations, Good Clinical Practice (GCP), Good Manufacturing Practices (GMP), Personalized medicine regulatory challenges, Pharmaceutical industry compliance, Quality Management Systems (QMS), Regulatory intelligence, Risk management in pharmaceuticals

@Booklet{EasyChair:13669,
  author = {Olawale Ajala},
  title = {Ensuring Compliance with FDA Regulations in the Pharmaceutical Industry},
  howpublished = {EasyChair Preprint no. 13669},

  year = {EasyChair, 2024}}