Comparison of GMP for Drugs in EU, US, Canada, WHO and Australia

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.

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Publication Details

Journal
International Journal of Drug Regulatory Affairs
Published
2024-12-15
DOI
https://doi.org/10.22270/ijdra.v12i4.724
Citations
3
Primary Topic
Pharmaceutical studies and practices
Type
article
Field-Weighted Citation Impact
3.33
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article

Comparison of GMP for Drugs in EU, US, Canada, WHO and Australia

Akshda Patil, Medha Devidas Kuchal, Prasanthi Domaraju
3 citations
International Journal of Drug Regulatory Affairs
Pharmaceutical studies and practices
3.33
article

Comparison of GMP for Drugs in EU, US, Canada, WHO and Australia

Akshda Patil, Medha Devidas Kuchal, Prasanthi Domaraju
article en
3 citations

Abstract

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.

International Journal of Drug Regulatory AffairsVol. 12(4)
University Health Care System (US), G Pulla Reddy Dental College & Hospital (IN), Osmania University (IN)
Good health and well-being
Openalex Percentile: Top 7%
Pharmaceutical studies and practices
3.33
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Comparison of GMP for Drugs in EU, US, Canada, WHO and Australia — Akshda Patil, Medha Devidas Kuchal, et al. · International Journal of Drug Regulatory Affairs (2024) | TGRS Research Map | TGRS