Journal of Pharmacopuncture (대한약침학회지)

KOREAN PHARMACOPUNCTURE INSTITUTE (대한약침학회)
권호 표지
DOI QR코드

DOI QR Code

Quality Control of Pharmacopuncture: A Comparative Study of Good Manufacturing Practice and External Herbal Dispensary Standards

  • Han, Ji-Eun (Department of Policy Development, National Development Institute of Korean Medicine) ;
  • Park, Minjung (National Agency for Development of Innovative Technologies in Korean Medicine) ;
  • An, Tteul-E-Bom (Kind Cloud Korean Medicine Clinic) ;
  • Park, Jong-Hyun (Department of Pathology, College of Korean Medicine, Dae-Gu Haany University) ;
  • Oh, Danny (Grauate School of Social Welfare, Soongsil University) ;
  • Kim, Kyeong Han (Department of Preventive Medicine, College of Korean Medicine, Woosuk University) ;
  • Sung, Soo-Hyun (Department of Policy Development, National Development Institute of Korean Medicine)
  • Received : 2021.03.31
  • Accepted : 2021.04.14
  • Published : 2021.06.30
Download PDF
⟨ Previous Next ⟩

Abstract

Objectives: We aimed to compare the external herbal dispensary (EHD) evaluation criteria for pharmacopuncture and the Korea Good Manufacturing Practice (KGMP) sterile medicine standards to contribute to the establishment of quality control criteria for pharmacopuncture. Methods: We obtained the KGMP standards from the Ministry of Food and Drug Safety and the pharmacopuncture certification criteria from the Ministry of Health and Welfare of South Korea. The EHD evaluation items were classified into three categories: facilities, quality control, and validation. The evaluation items were compared with the KGMP sterile medicine criteria to determine their conformance with each other, followed by a discussion among the committee of six experts and their consensus to suggest the items to complement the EHD evaluation criteria. Results: Among the KGMP sterile medicine criteria, 44 were related to the management of the facilities, and 32 pharmacopuncture evaluation items corresponded to these KGMP items (66.7%). Fifty-eight KGMP criteria were related to quality management, and 42 pharmacopuncture evaluation items corresponded to these KGMP items (72.4%). Twentyfive KGMP sterile medicine criteria were related to validation, and 11 pharmacopuncture evaluation items corresponded to these KGMP items (44.0%). Sixteen items under the pharmacopuncture EHD criteria corresponded to the KGMP sterile medicine criteria based on the consent of the experts. Among these, 4 were related to facility management, 6 were related to quality control, and 6 were related to validation. Conclusion: For the safety and quality control of pharmacopuncture, there is a need to select the criteria for the mandatory items among the proposed pharmacopuncture-EHD criteria laws and systems to ensure that the pharmacopuncture materials are produced under the pharmacopuncture-EHD in compliance with the relevant requirements. More studies are needed to secure the safety level of pharmacopuncture materials corresponding to that of conventional medicine.

Keywords

Acknowledgement

This research was supported by a grant from the Project of National Development Institute of Korean Medicine, Accreditation of External Herbal Dispensaries of Traditional Korean Medicine Clinics, funded by the Korea Ministry of Health and Welfare.

References

  1. Park J, Lee H, Shin BC, Lee MS, Kim B, Kim JI. Pharmacopuncture in Korea: a systematic review and meta-analysis of randomized controlled trials. Evid Based Complement Alternat Med. 2016;2016:4683121.
  2. Lee YJ, Shin JS, Lee J, Kim MR, Park KB, Lee HD, et al. Usage report of pharmacopuncture in musculoskeletal patients visiting Korean medicine hospitals and clinics in Korea. BMC Complement Altern Med. 2016;16(1):292. https://doi.org/10.1186/s12906-016-1288-5
  3. Kim DH, Cho SJ, Ko JA. Policy improvement plan based on Korean medicine use. Wonju: Health Insurance Review & Assessment Service; 2015. 185 p.
  4. Shin YS, Shin JS, Lee J, Lee YJ, Kim MR, Ahn YJ, et al. A survey among Korea Medicine doctors (KMDs) in Korea on patterns of integrative Korean Medicine practice for lumbar intervertebral disc displacement: preliminary research for clinical practice guidelines. BMC Complement Altern Med. 2015;15(1):432. https://doi.org/10.1186/s12906-015-0956-1
  5. Park JE. A survey on Korean medicine doctor's use of Herbal Acupuncture and recognition of its national health insurance coverage [master's thesis]. [Seoul]: Kyung Hee University; 2018. 68 p.
  6. Kim S, Lee J, Shin M. Mesotherapy with snake venom pharmacopuncture to treat hand eczema: two cases report. J Pharmacopuncture. 2020;23(4):273-6. https://doi.org/10.3831/KPI.2020.23.4.273
  7. Lee IS, Kang KS, Kim SY. Panax ginseng pharmacopuncture: current status of the research and future challenges. Biomolecules. 2019;10(1):33. https://doi.org/10.3390/biom10010033
  8. Jittiwat J, Wattanathorn J. Ginger pharmacopuncture improves cognitive impairment and oxidative stress following cerebral ischemia. J Acupunct Meridian Stud. 2012;5(6):295-300. https://doi.org/10.1016/j.jams.2012.09.003
  9. Yamasaki SC, Mendes MT, Alponti RF, Silveira PF. Efficacy of parenteral administration of bee venom in experimental arthritis in the rat: a comparison with methotrexate. Toxicon. 2015;98:75-88. https://doi.org/10.1016/j.toxicon.2015.02.016
  10. Shen L, Lee JH, Joo JC, Park SJ, Song YS. Bee venom acupuncture for shoulder pain: a systematic review and meta-analysis of randomized controlled trials. J Pharmacopuncture. 2020;23(2):44-53. https://doi.org/10.3831/KPI.2020.23.008
  11. Noh JH, Park JA, Youn HM, Jang KJ, Song CH, Ahn CB, et al. The effect of Hominis Placenta Pharmacopuncture on leg spasticity of stroke patients (a pilot study, double blind, randomized, controlled clinical trial). J Pharmacopuncture. 2009;12(4):97-110. https://doi.org/10.3831/KPI.2009.12.4.097
  12. Park JW, Yoon SW, Kim JS, Ryu BH. A clinical pilot study of Carthami-Semen herbal acupuncture treatment for chronic constipation. J Korean Acupunct Moxib Soc. 2008;25(5):127-37.
  13. Cheon S, Zhang X, Lee IS, Cho SH, Chae Y, Lee H. Pharmacopuncture for cancer care: a systematic review. Evid Based Complement Alternat Med. 2014;2014:804746.
  14. Ministry for Health, Welfare and Family affairs. Guideline on installation and utilization of external herbal dispensaries of traditional Korean medicine clinics and share-use of herbal dispensaries. Sejong: Ministry for Health, Welfare and Family affairs; 2009. 14 p.
  15. Sung SH, Shin BC, Park MJ, Kim KH, Kim JW, Ryu JY, et al. Current status of management on pharmacopuncture in Korea through introduction of an accreditation system. J Pharmacopuncture. 2019;22(2):75-82. https://doi.org/10.3831/kpi.2019.22.009
  16. Wacker M. Nanocarriers for intravenous injection--the long hard road to the market. Int J Pharm. 2013;457(1):50-62. https://doi.org/10.1016/j.ijpharm.2013.08.079
  17. International Council for Harmonisation (ICH). Q7 - good manufacturing practice guide for active pharmaceutical ingredients. Geneva: International Council for Harmonisation (ICH); 2000. 43 p.
  18. Current Good Manufacturing Practice (CGMP) Regulations [Internet]. Silver Spring: U.S. Food & Drug Administration; 2020 Sep 21 [cited 2021 Jan 12]. Available from: https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations.
  19. Good Manufacturing Practice (GMP) Guidelines [Internet]. Brussels: European Commission; [cited 2021 Jan 12]. Available from: https://ec.europa.eu/health/documents/eudralex/vol-4_en.
  20. Sung SH, Han JE, Ryu JY, Sung AD, Park JY, Ha IH, et al. Current status and future perspective of external herbal dispensaries preparing traditional herbal medicine in South Korea: the first National-Wide Survey results. BMC Complement Med Ther. 2020;20(1):354. https://doi.org/10.1186/s12906-020-03094-0
  21. Korea Ministry of Food and Drug Safety [Internet]. Cheongju: Korea Ministry of Food and Drug Safety; [cited 2021 Jan 21]. Available from: https://www.mfds.go.kr/eng/index.do.
  22. Regulations on Drug Manufacture and Qualilty Control [Internet]. Cheongju: Ministry of Food and Drug Safety; 2018 Nov 30 [cited 2021 April 15]. Available from: https://www.law.go.kr/LSW/admRulLsInfoP.do?admRulSeq=2100000176361.
  23. Degree on Facility Standards for Manufacturing Business and Importers of Drugs, Etc. [Internet]. Cheongju: Ministry of Food and Drug Safety; 2019 Nov 11 [cited 2021 April 15]. Available from: https://www.law.go.kr/%EB%B2%95%EB%A0%B9/%EC%9D%98%EC%95%BD%ED%92%88%EB%93%B1%EC%9D%98%EC%A0%9C%EC%A1%B0%EC%97%85%EB%B0%8F%EC%88%98%EC%9E%85%EC%9E%90%EC%9D%98%EC%8B%9C%EC%84%A4%EA%B8%B0%EC%A4%80%EB%A0%B9%EC%8B%9C%ED%96%89%EA%B7%9C%EC%B9%99.
  24. Rules on Saftey of Drug. Etc. [Internet]. Cheongju: Ministry of Food and Drug Safety; 2020 Oct 14 [cited 2021 April 15]. Available from: https://www.law.go.kr/%EB%B2%95%EB%A0%B9/%EC%9D%98%EC%95%BD%ED%92%88%EB%93%B1%EC%9D%98%EC%95%88%EC%A0%84%EC%97%90%EA%B4%80%ED%95%9C%EA%B7%9C%EC%B9%99.
  25. Korea Ministry of Health and Welfare [Internet]. Sejong: Korea Ministry of Health and Welfare; [cited 2021 Jan 21]. Available from: http://www.mohw.go.kr/eng/index.jsp.
  26. Korea Ministry of Health and Welfare. Certification standards of external herbal dispensary. Sejong: Korea Ministry of Health and Welfare; 2018. 177 p.
  27. U.S. Food and Drug Administration. Guidance for industry, sterile drug products produced by aseptic processing - current good manufacturing practice. Rockville: U.S. Food and Drug Administration; 2004. 59 p.
  28. Hoffmann A, Kahny-Simonius J, Plattner M, Schmidli-Vckovski V, Kronseder C. Computer system validation: an overview of official requirements and standards. Pharm Acta Helv. 1998;72(6):317-25. https://doi.org/10.1016/S0031-6865(97)00028-9
  29. Korean Pharmacopuncture Institute. Pharmacopuncturology. 2nd ed. Seoul: Elsevier Korea; 2011. 530 p.
  30. Choi DW, Kim JH, Cho SY, Kim DH, Chang SY. Regulation and quality control of herbal drugs in Korea. Toxicology. 2002;181-182:581-6. https://doi.org/10.1016/S0300-483X(02)00487-0
  31. Knoess W, Wiesner J. The globalization of traditional medicines: perspectives related to the European union regulatory environment. Engineering. 2019;5(1):22-31. https://doi.org/10.1016/j.eng.2018.11.012
  32. Dobuzinskis L, Howlett M, Laycock D. Policy analysis in Canada: the state of the art. Toronto: University of Toronto Press; 2007. 603 p.
  33. Lindstrom-Gommers L, Mullin T. International conference on harmonization: recent reforms as a driver of global regulatory harmonization and innovation in medical products. Clin Pharmacol Ther. 2019;105(4):926-31. https://doi.org/10.1002/cpt.1289