Good Manufacturing Practice (GMP): History, structure and its significance

  • Abhimanyu Rampal x
  • S P Yamini Kanti

Abstract

Good Manufacturing Practice (GMP) is set of guidelines enforced by USFDA under 21 CFR. Every Manufacturer of Food, Cosmetics, Pharmaceuticals products, Medical Devices & Dietary products should follow these guidelines in order to be sure that their product is safe and effective to be put in the market and for use by general population. The parameters of GMP for different Categories may vary but there is only one aim & that is to prevent any kind of harm that can occur to the final user of the product.

Keywords: GMP, USFDA, EUROPE, CANADA, TGA, ANVISA

Downloads

Download data is not yet available.

References

1. Learoyd.P. Good Manufacturing Practices or ‘GMP’ A Brief Guide, NBS-Scientific and Technical Training STT-040; 2005 Sept.
2. Shadle. PJ. Overview of GMPs, BioPharm International [Internet]. 2004 [cited 2020 Aug 12]. Available from:
http://www.biopharminternational.com/biopharm/artile/articleDetail.jsp?id=134225&pageID=2.
3. FDA. An Overview of FDA [Internet]. US:FDA; 2007 [cited 2020 Aug 17]. Available from:
http://www.fda.gov/ oc/opacom/fda101/sld013.html
4. Time Line: Chronology of Drug Regulation in the United States [Internet]. US:FDA; 2007 [cited 2020 Aug 27]. Available from:
http://www.fda.gov/cder/about/history/time1.html
5. Immel. BK. A Brief History of the GMPs, Regulatory Compliance Newsletter. Winter [Internet]. GMP Labeling; 2020 [cited 2020 Aug 17]. Available from:
http://www.gmplabeling.com/catalog/news1105.pdf
6. WHO TRS. WHO expert committee on specifications for pharmaceutical preparations: thirty-second report. Geneva :WHO technical report series- 823, ISBN 92 4140823 6, ISSN; 1992 .p. 0512- 3054.
7. Schedule M. good manufacturing practices and requirements of premises, plant and equipment for pharmaceutical products; [Internet]. New Delhi: CDSCO; 2012 Mar 25 [cited 2020 Aug 17]. Available from:
cdsco.nic.in/html/GMP/Schedule(GMP).pdf
8. PIC/S Secretariat (Ed.): Guide to Good Manufacturing Practice for medicinal products, Pharmaceutical inspection convention/ pharmaceutical inspection co-operation scheme PE 009-2 1 July 2005. Geneva: PICS; 2004 Jul
9. US food & Drug Administration. CFR code of federal regulation [Internet]. USA: FDA; 2019 Sep [cited 2020 Aug 12]. Available from:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211
10. Huber. L. Validation of analytical methods and procedures. [Internet]. Lab compliance; 2012 Mar 25 [cited 2020 Aug 17]. Available from:
labcompliance.com/tutorial/methods/default.aspx.
11. Eudralex: 2012. Eudralex-Volume 4 Good manufacturing practice (GMP) Guidelines [Internet]. EU: EMEA; 2011 Jan [cited 2020 Aug 17]. Available from:
ec.europa.eu/health/documents/Eudralex/vol-4/index_en.htm.
12. WHO TRS: Annex 2 Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms. In; WHO expert committee on specifications for pharmaceutical preparations. Geneva: Fortieth report WHO technical report series 937; 2006 .p. 45-84.
13. Absolute Quality Certification Pvt. Ltd. GMP Certification, [Internet]. 2020 [cited 2020 Aug 13]. Available from:
http://www.absolutecertification.com/GMP.aspx [Accessed on 2 November 2020].
14. Government of Canada. Health Canada [Internet]. Canada: Health Canada [Internet]. 2020 [cited 2020 Aug 13]. Available from:
https://www.canada.ca/en/health-canada.html
15. Australian Government. Therapeutic Good’s Administration [Internet]. Australia: TGA; 2020 [cited 2020 Aug 12]. Available from:
https://www.tga.gov.au/.
16. Ministerio da saude. Agencia National de Vigilancia Sanitaria [Internet]. Brazil: ANVISA; 2020 [cited 2020 Aug 12]. Available from:
https://www.gov.br/anvisa/pt-br.
17. US Department of Health & Human Services. US food & Drug Administration [Internet]. US: USFDA; 2020 [cited 2020 Aug 12]. Available from:
https://www.fda.gov/home
18. European Union. European Medicines Agency [Internet]. EU: EMA; 2020 [cited 2020 Aug 12]. Available from:
https://www.ema.europa.eu/en
19. UK Government. Medicines & Healthcare products Regulatory Agency [Internet]. UK:MHRA;2020 [cited 2020 Aug 12]. Available from:
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
20. South Africa Government. South African Health Products Regulatory Authority [Internet]. SAHPRA; 2020 [cited 2020 Aug 12]. Available from:
https://www.sahpra.org.za/
21. European Commission. Medicinal Products. Eudralex-Volume 4. GMP Guidelines [Internet]. EU: EMA; 2020 [cited 2020 Aug 16]. Available from:
https://ec.europa.eu/health/documents/eudralex/vol-4_en
22. USFDA. Current Good Manufacturing Practice Regulations. Code of Federal Regulations. [Internet]. US:USFDA;2020 [cited 2020 Aug 16]. Available from:
https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations
23. European Medicines Agency. ICH Q7, GMP for Active Pharmaceutical Ingredient [Internet]. EU: EMA;2020 [cited 2020 Aug 16]. Available from:
https://www.ema.europa.eu/en/ich-q7-good-manufacturing-practice-active-pharmaceutical-ingredients
24. PIC/S. GM (D) P Harmonization. GMP Standards [Internet]. PICS; 2020 [cited 2020 Aug 16]. Available from:
https://picscheme.org/en/activites-gmdp-harmonisation
25. Government of Canada. Health Canada. Good Manufacturing Practices guide for drug products [Internet]. Canada: Health Canada; 2020 [cited 2020 Aug 16]. Available from:
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/gmp-guidelines-0001/document.html
Statistics
601 Views | 392 Downloads
How to Cite
Rampal, A., and S. P. Yamini Kanti. “Good Manufacturing Practice (GMP): History, Structure and Its Significance”. International Journal of Drug Regulatory Affairs, Vol. 8, no. 4, Dec. 2020, pp. 66-72, doi:10.22270/ijdra.v8i4.439.