Quality Control of Pharmacopuncture: A Comparative Study of Good Manufacturing Practice and External Herbal Dispensary Standards
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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.
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.
참고문헌 (33)
- Park J, "Pharmacopuncture in Korea : a systematic review and meta-analysis of randomized controlled trials", Evid Based Complement Alternat Med, 2016, pp.4683121~ (2016)
- Lee YJ, "Usage report of pharmacopuncture in musculoskeletal patients visiting Korean medicine hospitals and clinics in Korea", BMC Complement Altern Med, 16(1), pp.292~ (2016)
- Policy improvement plan based on Korean medicine use, "Kim DH", Health Insurance Review & Assessment Service, 185~ (2015)
- Shin YS, "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, 15(1), pp.432~ (2015)
- Park JE, "A survey on Korean medicine doctor’s use of Herbal Acupuncture and recognition of its national health insurance coverage", master’s, pp.2018
- Sungha Kim, "Mesotherapy with Snake Venom Pharmacopuncture to Treat Hand Eczema: Two Cases Report", Journal of Pharmacopuncture, 23(4), pp.273~276 (2020), 대한약침학회
- Lee IS, "Panax ginseng pharmacopuncture : current status of the research and future challenges", Biomolecules, 10(1), pp.33~ (2019)
- Jintanaporn Wattanathorn, "Ginger Pharmacopuncture Improves Cognitive Impairment and Oxidative Stress Following Cerebral Ischemia", Journal of Acupuncture & Meridian Studies, 5(6), pp.295~300 (2012), 사단법인약침학회[DOI]
- Yamasaki SC, "Efficacy of parenteral administration of bee venom in experimental arthritis in the rat : a comparison with methotrexate", Toxicon, 98, pp.75~88 (2015)
- Lei Shen, "Bee Venom Acupuncture for Shoulder Pain: A Systematic Review and Meta-analysis of Randomized Controlled Trials", Journal of Pharmacopuncture, 23(2), pp.44~53 (2020), 대한약침학회
- 노주환, "중풍 환자의 하지 경직에 대한 자하거 약침의 효과 연구", Journal of Pharmacopuncture, 12(4), pp.97~110 (2009), 대한약침학회
- 박재우, "만성변비에 대한 홍화약침의 효능 연구", Journal of Acupuncture Research, 25(5), pp.127~138 (2008), 대한침구의학회
- Cheon S, "Pharmacopuncture for cancer care : a systematic review", Evid Based Complement Alternat Med, 2014, pp.804746~ (2014)
- 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", Ministry for Health, Welfare and Family affairs, 14~ (2009)
- 성수현, "Current Status of Management on Pharmacopuncture in Korea through Introduction of an Accreditation System", Journal of Pharmacopuncture, 22(2), pp.75~82 (2019), 대한약침학회[DOI]
- Wacker M, "Nanocarriers for intravenous injection--the long hard road to the market", Int J Pharm, 457(1), pp.50~62 (2013)
- International Council for Harmonisation (ICH), "Q7 - good manufacturing practice guide for active pharmaceutical ingredients", International Council for Harmonisation (ICH), 43~ (2000)
- "Current Good Manufacturing Practice (CGMP) Regulations" (2020)[URL]
- "Good Manufacturing Practice (GMP) Guidelines"[URL]
- Sung SH, "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, 20(1), pp.354~ (2020)
- "Korea Ministry of Food and Drug Safety"[URL]
- "Regulations on Drug Manufacture and Qualilty Control" (2018)[URL]
- "Degree on Facility Standards for Manufacturing Business and Importers of Drugs, Etc" (2019)[URL]
- "Rules on Saftey of Drug. Etc" (2020)[URL]
- "Korea Ministry of Health and Welfare"[URL]
- Korea Ministry of Health and Welfare, "Certification standards of external herbal dispensary", Korea Ministry of Health and Welfare, 177~ (2018)
- U.S. Food and Drug Administration, "Guidance for industry, sterile drug products produced by aseptic processing - current good manufacturing practice", U.S. Food and Drug Administration, ~ (2004)
- Hoffmann A, "Computer system validation : an overview of of-ficial requirements and standards", Pharm Acta Helv, 72(6), pp.317~325 (1998)
- Korean Pharmacopuncture Institute, "Pharmacopuncturology", pp.530~ (2011), Elsevier Korea
- Choi DW, "Regulation and quality control of herbal drugs in Korea", Toxicology, 181-182, pp.581~586 (2002)
- Knoess W, "The globalization of traditional medicines : perspectives related to the European union regulatory environment", Engineering, 5(1), pp.22~31 (2019)
- Dobuzinskis L, "Policy analysis in Canada: the state of the art", pp.603~ (2007), University of Toronto Press
- Lindström-Gommers L, "International conference on harmonization: recent reforms as a driver of global regulatory harmonization and innovation in medical products", Clin Pharmacol Ther, 105(4), pp.926~931 (2019)