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A Study on the Comparison of Korea Good Manufacturing Practice (KGMP) Evaluation Criteria with Certification Criteria of Extramural Herbal Dispensaries

원외탕전실 평가인증기준과 KGMP 평가인증 기준과의 비교연구

  • Hyeong-Gi Kim (School of Korean Medicine, Pusan National University) ;
  • Eui-Hyoung Hwang (School of Korean Medicine, Pusan National University) ;
  • Eun-Gyeong Lee (R&D Division, HAMSOA Pharmaceutical Co. Ltd) ;
  • Byung-Mook Lim (Division of Humanities and Social Medicine, School of Korean Medicine, Pusan National University) ;
  • Young-Jae Shin (Department of Korean Medicine Rehabilitation, Pusan National University Korean Medicine Hospital) ;
  • Sun-Young Park (School of Korean Medicine, Pusan National University) ;
  • Byung-Cheul Shin (School of Korean Medicine, Pusan National University)
  • 김형기 (부산대학교 한의학전문대학원) ;
  • 황의형 (부산대학교 한의학전문대학원) ;
  • 이은경 (함소아 제약 연구개발본부) ;
  • 임병묵 (부산대학교 한의학전문대학원 인문사회의학교실) ;
  • 신영재 (부산대학교 한방병원 한방재활의학과) ;
  • 박선영 (부산대학교 한의학전문대학원) ;
  • 신병철 (부산대학교 한의학전문대학원)
  • Received : 2023.10.12
  • Accepted : 2023.11.25
  • Published : 2023.11.30

Abstract

Objectives : This study aimed to find out the future direction of accreditation system of Extramural herbal dispensaries (EHD) by comparing the current criteria of EHD and the existing Korea good manufacturing practice (GMP) regulations. Methods : Among the accreditation criteria of EHD, criteria of general herbal medicine was compared with the pharmaceutical GMP of Korea. The regulations of the accreditation of EHD and the regulations of KGMP were compared and organized with similar things based on the index of KGMP. All criteria from both were extracted for each element, classified into key-words and evaluated by dividing them into the same, similar one and no-matching. Results : Among the 189 criteria of KGMP, 77 criteria were consistent with the accreditation of EHD, and 15 criteria were similar. Based on the accreditation of EHD, 70.4% of the criteria were consistent or similar to KGMP. There were a total of 27 key-words only in the GMP criteria and not in the EHD one. Hence, a total of 25 key-words only in the EHD criteria and not in the GMP one. There were 12 similar key-words, and among them, there were 4 key-words in which accreditation of EHD was more specific than the KGMP. Conclusions : The criteria of general herbal medicine in EHD showed a similar or equivalent level of accreditation criteria compared to that of pharmaceutical GMP in Korea, and it ts believed that it should be considered at the current level to reflect the characteristics of herbal medicine.

Keywords

References

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