The Impact of Regulatory Controls on Pharmaceutical Manufacturing Processes

EasyChair Preprint no. 13699

Abstract

This comprehensive article explores the multifaceted impact of regulatory controls on pharmaceutical manufacturing processes. Regulatory frameworks are essential for ensuring the safety, efficacy, and quality of pharmaceutical products. Beginning with a historical overview of pharmaceutical regulation, the article identifies key regulatory bodies such as the FDA, EMA, and ICH, and examines their frameworks and specific requirements for compliance. The impact of these regulations on manufacturing processes is analyzed, highlighting benefits such as standardized quality and safety, alongside challenges like increased costs and complexity. Technological innovations that aid compliance and enhance efficiency are discussed, along with the critical role of regulatory controls in maintaining integrity throughout the pharmaceutical supply chain. The article concludes with an exploration of future trends in regulatory controls and their potential impacts on the industry, emphasizing the ongoing importance of adaptive regulatory frameworks in a rapidly evolving pharmaceutical landscape.

Keyphrases: Artificial Intelligence in Compliance, Automation in Manufacturing, Blockchain for Traceability, clinical trials, Compliance Training Programs, Data Integrity, Digital Transformation, Good Distribution Practices (GDP), Good Manufacturing Practices (GMP), New Drug Introductions, pharmaceutical supply chain, Pharmacovigilance, Post-Approval Obligations, Quality Management Systems (QMS), Regulatory Compliance, risk management, Supplier Qualification, Supply Chain Security, Sustainable Practices in Pharmaceuticals, Technology in Pharmaceuticals

@Booklet{EasyChair:13699,
  author = {Olawale Ajala},
  title = {The Impact of Regulatory Controls on Pharmaceutical Manufacturing Processes},
  howpublished = {EasyChair Preprint no. 13699},

  year = {EasyChair, 2024}}