ABSTRACT

The pharmaceutical business and related sectors are subject to stringent regulatory standards across the globe, with Good Manufacturing Practices (GMP) acting as the cornerstone to ensure product efficacy, safety, and quality. This article compares the GMP regulations of four distinct countries: the United States (USA), Australia, Canada, and India. All of these nations work hard to safeguard public health, but they approach the task in different ways. The FDA in the USA enforces stringent and comprehensive GMP regulations, emphasizing meticulous documentation and routine facility inspections. While coordinating its GMP regulations with international standards, Australia's Therapeutic Goods Administration (TGA) places a strong emphasis on accountability and traceability. Like other nations, Canada bases its legislation on international standards and regularly adopts FDA regulations; Health Canada is in charge of overseeing compliance and inspections. India complies with (WHO) standards while maintaining varying levels of rigor in its GMP framework across different regions. The similarities and differences between these countries' GMP standards, regulatory agencies, paperwork requirements, and inspection practices are investigated in this analysis. It highlights how important it is to stay current with GMP regulations and how tailored compliance protocols are necessary to address the unique circumstances of every nation. Pharmaceutical firms and enterprises in related industries need to be proactive in upholding GMP standards, keeping in mind the particular regulatory frameworkof the nation in which they operate. Comprehending the variations in GMP regulations can aid interested parties in making informed decisions, optimizing their manufacturing processes, and ultimately propelling the worldwide endeavor to guarantee the excellence and security of medications. Keywords: Health Canada, Good Manufacturing Practices, FDA, TGA, and WHO
Publication date: 01/11/2024

https://ijbpas.com/pdf/2024/November/MS_IJBPAS_2024_8461.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.11.8461