Department of Regulatory Affairs, G. Pulla Reddy College of Pharmacy, Osmania University, Mehdipatnam-500028, Hyderabad, Telangana, India
Online published on 8 July, 2025.
Good Manufacturing Practices (GMP) are essential for ensuring the safety, quality, and efficacy of pharmaceutical products. GMP covers all aspects of production, including personnel training, equipment maintenance, and facility sanitation. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. This article provides a comparative analysis of GMP regulations across five key regions: the European Union (EU), United States (US), World Health Organization (WHO), Canada, and Australia. The regulations and guidelines followed by EU, US, WHO, Canada, and Australia are mentioned in this article. By identifying both the convergences and divergences in these guidelines, the study highlights how regional practices address the challenges of drug safety and efficacy in a globalized market, ultimately contributing to improved public health outcomes.
Good Manufacturing Practices, GMP regulations, Quality assurance, Drug efficacy, Regulatory compliance, Production standards, Quality control, Risk management, WHO