• 약학회지
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• 제57권6호
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• pp.432-441
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• 2013

It's been almost 20 years since the adoption of Good Manufacturing Practices (GMP) in Korea since 1994. There have been big progresses in the GMP regulations and its implementations. 'New GMP' in 2008 has adopted validation, pre-approval GMP evaluation, annual quality review, etc.. Upon the submission of PIC/S (Pharmaceutical Inspection Cooperation Scheme) application by Korea's Ministry of Food and Drug Safety in April, 2012, Korea is facing new opportunity to level up Korea GMP regulations. As such, this study suggested GMP revision points by comparing and analyzing the differences between PIC/S GMP and Korea GMP. Those areas which GMP is not required such as radiopharmaceuticals and medical gases should adopt GMP. And independent GMP regulation is needed for Active Pharmaceutical Ingredients and investigational medicinal products. Also, those regulations shall be implemented in the higher level of legal status. Finally, rather than pursuing GMP harmonization only for PIC/S membership, GMP improvement in the long term shall be taken into consideration by reflecting current quality issues such as ICH Q8 (Pharmaceutical development), Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System).

• 약학회지
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• 제59권1호
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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).

• 한국건축시공학회지
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• 제18권3호
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• pp.295-303
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• 2018

현재 DBB 발주방식에서는 설계단계와 시공단계가 분리되어 있어, 잦은 설계변경이 발생하고 있다. 아울러 공사비초과, 공기지연 및 품질저하를 야기하는 문제점들을 초래하고 있다. 최근에 발주자의 다양한 요구, 제한적인 예산 및 공기 등의 제약조건에 대응할 수 있는 발주방식인 CM@R 발주방식이 대두되고 있다. CM@R 발주방식에서는 설계단계에서 발주자와 협의하여 GMP를 정하고, GMP 내에서 CM수행자가 책임을 지고 공사를 수행하는 방식이다. 그러나 CM@R 특성상 완성되지 않은 도서를 기준으로 GMP를 산정하기 때문에 불확실성이 내재되어 있다. 본 연구에서는 GMP 산정시 불확실성을 고려하기 위하여, CBR를 이용한 공사비 예측 및 MCS를 적용한 확률론적 초기 GMP 산정방안을 제시하였으며, 초기 GMP 산정 이후 사업진행에 따라 GMP 협의를 수행할 수 있는 프로세스를 제시하였다. 사례연구 및 검증을 통하여 확률론적 초기 GMP 산정방안을 검증하였다. 본 연구에서는 제시된 확률론적 GMP 산정방안을 통하여 GMP의 범위를 설정하고 발주자와 CM수행자가 협의을 통해 리스크를 줄임으로써, CM@R의 성공적인 국내 도입에 일조하고자 하였다.

• Archives of Pharmacal Research
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• 제22권1호
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• pp.48-54
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• 1999

These studies were designed to examine the differential effect of nitric oxide (NO) and cGMP on glutamate neurotransmission. In primary cultures of rat cerebellar granule cells, the glutamate receptor agonist N-methyl-D-aspartate (NMDA) stimulates the elevation of intracellular calcium concentration ($[Ca^{2+}]_i$), the release of glutamate, the synthesis of NO and an increase of cGMP. Although NO has been shown to stimulate guanylyl cyclase, it is unclear yet whether NO alters the NMDA-induced glutamate release and ${[Ca^{2+}]}_i$ elevation. We showed that the NO synthase inhibitor, NG-monomethyl-L-arginine (NMMA), partially prevented the NMDA-induced release of glutamate and elevation of ${[Ca^{2+}]}_i$ and completely blocked the elevation of cGMP. These effects of NO on glutamate release and [Ca2+]i elevation were unlikely to be secondary to cGMP as the cGMP analogue, dibutyryl cGMP (dBcGMP), did not suppress the effects of NMDA. Rather, dBcGMP slightly augmented the NMDA-induced elevation of ${[Ca^{2+}]}_i$ with no change in the basal level of glutamate or ${[Ca^{2+}]}_i$. The extracellular NO scavenger hydroxocobalamine prevented the NMDA-induced release of glutamate providing indirect evidence that the effect of NO may act on the NMDA receptor. These results suggest that low concentration of NO has a role in maintaining the NMDA receptor activation in a cGMP-independent manner.

• Applied Biological Chemistry
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• 제41권6호
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• pp.410-413
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• 1998

Gel filtration과 ion exchange chromatography, reversed-phase 및 ion exchange FPLC를 이용하여 고려인삼 뿌리에서 subunit 분자량 약 25 kDa의 주요단백질(이하 GMP)을 분리하였다. PAS 염색을 통하여 GMP는 carbohydrate moiety를 갖는 당단백질일 가능성을 보여주었고, 이는 glycosidase 처리후 protein band shift 실험으로 확인되었다. GMP는 native polyacrylamide 전기영동 및 gel permeation FPLC를 통해 native form은 약 63 kDa의 분자량을 갖는 dimer로 판단된다. GMP의 생리활성 측정결과, inflammation mediator의 기능탐색에 쓰이는 anticomplementary activity를 보여주었다.

• 대한방사성의약품학회지
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• 제1권2호
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• pp.98-103
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• 2015

Good manufacturing Practice (GMP) regulation for diagnostic and therapeutic radiopharmaceuticals was prepared at 2014. The mandatory GMP regulation becomes effective on $1^{st}$, July 2015,with two years of grace periods. Korean radiopharmaceuticals GMP regulation was consisted of quality management, personnel, premise and facility, documentation, production, quality control and self-audit and they have a very similar structure to European Union and PIC/S GMP regulation. Here, we describe detailed description of GMP regulation each part and application to radiopharmaceuticals production. And we also compare Korea, Japan and USA radiopharmaceuticals GMP regulation. GMP is a method to maintain quality of radiopharmaceuticals in daily production and it must be embedded on the manufacturing operation and management.

• Journal of Ginseng Research
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• 제18권2호
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• pp.108-112
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• 1994

Rats (Sprague Dawley, male, 200 g) were fed with 15% corn oil containing a large quantity of 18 2 (linoleic acid) for 3 weeks, and were followed by feeding the petroleum ether extracts from Korean red ginseng for 3 weeks. cGMP was produced more in platelets prepared from both 15% corn oil and petroleum ether extracts-fed group than in platelets only 15% corn oil-fed group, indicating that the production of cGMP is increased by feeding the petroleum ether extracts. When this platelet was stimulated by phorbol-12-myristate-13-acetate (PMA), the level of cGMP was decreased. However, the platelets in medium containing protein fraction (200 $\mu\textrm{g}$/ml) was stimulated by PMA, the production of cGMP inhibited by PMA was increased by 3 times or more. These results suggest that both the protein fraction and the petroleum ether extracts from Korean red ginseng are synergistic in the productiorl of cGMP, and they may have the antiplatelet effects.

• 대한한의학회지
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• 제32권4호
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• pp.111-127
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• 2011

Objectives: The aim of this study was to establish a fundamental base for hGMP operational systems implementation. Method: The survey was done with a questionnaire developed through consulting specialists, in order to investigate the present state of manpower, facilities and capitalization of private enterprises, and opinions on what the road map for hGMP implementation must include. Results: The results showed that the business scales of related enterprises were relatively small. Education and health monitoring of employees has been done in fair amounts, but a standard must be established. Essential facilities required for herbal product production were present in most cases. Recognition and understanding of hGMP was low. Various opinions on the implementation of hGMP were gathered. Conclusion: Standardized hGMP education programs, plans to modify existing facilities, public announcements and advertisement of the system, and public assistance funds and tax privileges are needed for the successful implementation of the hGMP operational system.

• 폴리머
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• 제33권2호
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• pp.124-130
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• 2009

고분자를 저분자 유기물질의 결정화 과정에 사용하면 결정형성과정을 중간 단계, 즉 메조크리스탈 단계에서 멈출 수 있다. 메조크리스탈은 수백 나노미터-수 마이크로미터의 결정들이 스스로 배열되어 결정성을 갖는, 결정과 고분자의 복합초구조로 정의할 수 있다. 본 연구에서는 구아노신일인산의 메조크리스탈 형성에서 고분자의 영향과 그와 관련된 변수들에 대해 알아 보았다. OM과 SEM 분석을 통해 고분자유도 결정화에 의한 GMP 결정은 전형적인 GMP입자와는 다른 모폴로지를 보임을 확인하였고, XRD 분석을 통해 새로운 polymorph를 가짐을 확인하였다. 이러한 결과는 고분자에 의해 GMP의 결정구조가 달라졌음을 의미하며, 결정 안에 함유되는 물의 함량이 달라져 다른 수화물 구조를 보임을 TGA 분석을 통해 확인하였다.

• Design & Manufacturing
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• 제2권6호
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• pp.38-42
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• 2008

Recently, the demands of digital camera and miniature camera module for mobile-phone is increased significantly. Lenses which is the core component of optical products are made by the injection molding(plastic lens) or GMP(glass lens). Plastic lens is not enough to improve the resolution and performance of optic parts. Therefore, the requirement of glass lens is increased because it is possible to ensure the high performance and resolution. In this paper, the thermal stress analysis of 3 cavity GMP mold for molding glass lens was performed for estimating the thermal stress and amount of deformation. Finally, the modification plan based on the analysis results was deducted.