• Journal of Pharmacopuncture
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• v.24 no.2
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• pp.59-67
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• 2021

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.

• Proceedings of the PSK Conference
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• 2003.10a
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• pp.26-26
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• 2003

KGMP is the one of the most important part in Drug administration system which drug industry must comply to. KGMP was revised newly with the harmonization of other countries and keep face with new technologies. The big revision point is bulk drug GMP, blood products GMP, validation guideline and standardization of injection manufacturing. (omitted)

• The Korea Journal of Herbology
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• v.38 no.6
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• pp.61-71
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• 2023

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.

• YAKHAK HOEJI
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• v.59 no.1
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• pp.40-46
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• 2015

The term "GMP" firstly came on the 1962 amendment of the Federal Food, Drug and Cosmetic (FD&C) Act and the US FDA established and officially announced the Good Manufacturing Practice Regulation for the first time in the world in 1963. In 1969, the World Health Organization published the GMP regulation and recommended that member states adopt the GMP regulation and implement the "GMP Certification Scheme" for international commerce of finished pharmaceutical products. As a result, GMP requirements have become important ones that have to be complied with in the manufacture of pharmaceutical products. The Korean GMP regulation was announced as the official notification by the Ministry of Health and Social Affairs in 1977. The KGMP regulation was voluntarily adopted by pharmaceutical companies at the early stage, but it had become mandatory. In addition, various kinds of GMP regulations have been established to cover active pharmaceutical ingredients, biological products and others, in addition to finished pharmaceutical products. Taking account of technological development and changes in the pharmaceutical environments, the KGMP regulation was fully amended and harmonized with GMP requirements of developed countries. In this way, the KGMP has developed to keep up with international trends and standards, leading to accession to the Pharmaceutical Inspection Cooperation Scheme (PIC/S).

• Air Cleaning Technology
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• v.17 no.4 s.67
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• pp.20-38
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• 2004

• 동물약계
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• no.51
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• pp.2.1-2.1
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• 1998

[ $\cdot$ ]동물용의약부외품 제조업 심규 허가 $\cdot$동물용의약품등 신규 수입자확인 $\cdot$동물용의약품등 제조업 및 수입자 허가사항 변경 $\cdot$KGMP 증명서 변경 허가

• Journal of Pharmacopuncture
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• v.4 no.1
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• pp.87-101
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• 2001

• 동물약계
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• no.5
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• pp.3-3
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• 1993

1. 제조업 허가사항 변경 2. 국가검정 동물용의약품 국가검정 면제 3. KGMP 추진현황조사(93. 9. 2.) 4. 설명회 개최안내(93. 9. 8) 5. 의정활동 자료협조(93. 9. 16.) 6. 국가검정 동물의약품 관리 철저 요청(93. 9. 17.) 7. $\ulcorner$산업 및 품목분류표$\lrcorner$ 개선의견 제출(93. 9. 16.) 8. 생물학적제제 특별 관리 방안 중간 추진현황

• The Korean Chronic Disease News
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• no.307
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• pp.1-18
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• 2006

경기도 의왕시 보건소 임인동 소장/의료비지출 OECD국가 중 최하위/“암환자 96%가 정상활동 못해”/MRI 진료비 18.2% 환불조치/“진료비 부당 청구 심사 강화”/대형병원 환자 집중현상 심화/제왕절개 분만율 평가결과 공개/KGMP 국제적 수준 높인다/완제의약품 생산국가 표기‘명확’/“국내 제약산업 희생양”안 된다/‘산디문 뉴오랄’당뇨 발현억제/지역사회정신보건사업 선도적 추진/지역보건의료계획 어떻게 추진되고 있나/버섯, 항암 등 15가지 약리효과 입증/자궁경부암은 HPV가 주원인이다/증상 없다고 대장암 안심은‘금물’/1급발암 물질 석면 사용 금지/고지혈증/당뇨병과 비만/

• The Korean Chronic Disease News
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• no.310
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• pp.1-18
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• 2006

강원도 인제군 보건소 권장원 소장/‘만성질환관리사업지원단’설치.운영/경기도립노인전문병원 2008년 건립/전통 한의약 세계적 브랜드로 육성/인터넷 이용 결핵환자 원격판독/“간호조무사 대체 법적 근거 마련”/건보-자보 일원화 추진 논란/“아시아 당뇨 대란 심각하다”/2010년 세계뇌졸중학회 서울 유치/“성분명처방, 시간 필요하다”/생동성 관련 품목허가취소 가처분 수용/KGMP“ 의약품 품목별로 평가한다”/식약청, 11번째 국산 신약 시판 허가/내년부터 의약품 설명서 알기 쉽게 교체/군부대장병 금연환경조성을 위한 이동금연클리닉 사업/외래환자 1위는‘서울아산병원’/‘대한네트워크병의원협회’발족/뇌혈관질환 50대 이후 사망원인 1위 차지/건강한 생활습관이 심혈관질환 예방의 첩경/