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

GMP COMPARISON

  • Akshda Patil student
  • Medha Devidas Kuchal Research Scholar
  • Prasanthi D. Professor, Department of Regulatory Affairs, G. Pulla Reddy college of pharmacy, Osmania University, Mehdipatnam-500028, Hyderabad, Telangana, India

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.

Keywords: Good Manufacturing Practices, GMP regulations, Quality assurance, Drug efficacy, Regulatory compliance, Production standards, Quality control, Risk management, WHO

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Author Biographies

Akshda Patil, student

Department of regulatory affairs, G.Pulla Reddy College of Pharmacy

Medha Devidas Kuchal, Research Scholar

Department of Regulatory Affairs, G.Pulla Reddy College of Pharmacy

References

1. Menezes JC, Ferreira AP, Rodrigues LO, Brás LP, Alves TP. Chemometrics role within the PAT context: examples from primary pharmaceutical manufacturing [Internet]. Elsevier;
2009 [cited 2024 Oct 24]; p. 313-355. Available from:
doi:10.1016/B978-044452701-1.00012-0
2. Kamal Biswas. The Pharmaceutical Value Chain-An Introduction. Capter 2. [Internet]. Science direct; 2014 [cited 2024 Oct 24]; p. 9-65. Available from:
doi: 10.1016/B978-0-12-407662-4.00002-7
3. Jona Tarlengco. GMP: Good Manufacturing Practices [Internet]. Jona Tarlengco; 2024 Jul 26 [cited 2024 Oct 24]. Available from:
https://safetyculture.com/topics/gmp/
4. Medicines: Good manufacturing practices [Internet]. WHO; 2015 Nov 20 [cited 2024 Oct 24]. Available from:
https://www.who.int/news-room/questions-and-answers/item/medicines-good-manufacturing-processes
5. Sharma A, Gamta V, Luthra G. The Importance of Good Manufacturing Practices (GMP) in the Healthcare Industry. Journal of Pharmaceutical Research International. 2023 Jul 10;35(18):75-90. [cited 2024 Oct 24]. Available from:
https://journaljpri.com/index.php/JPRI/article/view/7394/14768
6. Chaudhri, Vikash & Yadav, Vijay & Verma, Praveen Kumar & Singh, Amit. A Review on Good Manufacturing Practice (GMP) for Medicinal Products. [Internet]. Researchgate; 2022 [cited 2024 October 23]. Available from:
https://www.researchgate.net/publication/366047170_A_Review_on_Good_Manufacturing_Practice_GMP_for_Medicinal_Products
7. Prequalification of medicines by WHO [Internet]. WHO; 2013 Jan 31 [cited 2024 Oct 25]. Available from:
https://www.who.int/news-room/fact-sheets/detail/prequalification-of-medicines-by-who
8. Health Products Policy and Standards [Internet]. WHO; [cited 2024 Oct 25]. Available from:
https://www.who.int/teams/health-product-and-policy-standards/standards-and-specifications/norms-and-standards-for-pharmaceuticals/guidelines/production
9. Good manufacturing practice [Internet]. European Union (EU); 2024 [cited 2024 Oct 25]. Available from:
https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice
10. Current Good Manufacturing Practice (CGMP) Regulations [Internet]. USFDA; 2023 Dec 29 [cited 2024 Oct 26] Available from:
https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations
11. Good manufacturing practices guide for drug products (GUI-0001)-Summary [Internet]. Canada: Government of Canada; 2020 Jul 01 [cited 2024 Oct 26] Available from:
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/gmp-guidelines-0001.html
12. PIC/S Guide to GMP for medicinal products – version 16 [Internet]. Australia: Therapeutic Goods Administration; 2024 Mar 01 [cited 2024 Oct 26] Available from:
https://www.tga.gov.au/resources/publication/publications/pics-guide-gmp-medicinal-products-version-16
13. Alexandre De Freire. Understanding the main differences between the Certification of EU-GMP (Good Manufacturing Practice) and other regions of the Globe [Internet]. Linkedin: Alexandre De Freire; 2024 Jun 18 [cited 2024 Oct 27] Available from:
https://www.linkedin.com/pulse/understanding-main-differences-between-certification-eu-gmp-ny3ce
14. EU vs US GMPs: Key differences [Internet]. Linkedin: Bioboston Consulting; 2023 Jun 29 [cited 2024 Oct 27] Available from:
https://www.linkedin.com/pulse/eu-vs-us-gmps-key-differences-biobostonconsulting#:~:text=The%20EU%20GMPs%20require%20manufacturers,specific%20requirement%20for%20a%20PQS
15. John G. Grazal and David S. Earl. EU and FDA GMP Regulations: Overview and Comparison [Internet]. John Wiley & Sons, Ltd.; 2024 Nov 22 [cited 2024 Oct 27] Available from:
https://onlinelibrary.wiley.com/doi/pdf/10.1002/%28SICI%2910991786%28199706%292%3A2%3C55%3A%3AAID-QAJ35%3E3.0.CO%3B2-X
16. GMP regulations in different countries | Comprehensive Overview [Internet]. US: GxP Cellators; 2023 [cited 2024 Oct 28] Available from:
https://gxpcellators.com/gmp-regulations-in-different-countries-comprehensive-overview/
17. EU and US GMPs | Understanding the Similarities and Differences [Internet]. 2024 Mar 15 [cited 2024 Oct 28] Available from:
https://pharmadigests.com/eu-and-us-gmps-understanding-the-similarities-and-differences/
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How to Cite
1.
Akshda Patil, Kuchal MD, Domaraju P. Comparison of GMP for Drugs in EU, US, Canada, WHO and Australia. Int J Drug Reg Affairs [Internet]. 2024Dec.15 [cited 2026May14];12(4):82-1. Available from: https://www.ijdra.com/index.php/journal/article/view/724