• YAKHAK HOEJI
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• v.57 no.6
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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).

• 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).

• Journal of the Korea Institute of Building Construction
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• v.18 no.3
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• pp.295-303
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• 2018

In the DBB delivery system, the design stage and the construction stage are separated. Because of this, design changes frequently occur, and problems such as construction cost overrun, schedule delay, and quality deterioration happen as well. Recently, in the construction industry CM at Risk(CM@R) delivery system, which can systematically solve the above-mentioned problems of DBB delivery system, meet various demands of clients, and overcome the limited cost and period. In the CM@R delivery system, the contractor negotiates for a maximum guaranteed price(GMP) with the client at the design stage, and the CM performer carries out the construction within the GMP. However, uncertainties are inherent in the GMP calculation because the calculation is based on unfinished drawings and documents. In this study, a Probabilistic Earlier GMP Calculation Method by combining a probabilistic tool of Monte Carlo simulation with a case based reasoning is proposed so that the uncertainty in GMP calculation is reflected. After the earlier GMP is calculated, a process to calculate the $2^{nd}$ GMP at the time of around 80 % of detailed deign and to negotiate with the client to fix the final GMP is proposed. The Probabilistic Earlier GMP Calculation Method is verified through the case study. In this study, researchers set the range of GMP through the proposed probabilistic GMP calculation and tried to reduce the risk through negotiation between the client and the CM performer. The proposed method and process would contribute to the successful introduction of CM@R in Korea.

• Archives of Pharmacal Research
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• v.22 no.1
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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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• v.41 no.6
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• pp.410-413
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• 1998

The major protein (GMP) from the roots of Panax ginseng C. A. Meyer was purified, using gel filtration and ion exchange chromatography followed by reversed-phase and ion exchange FPLC. Staining analysis indicated that the protein has a carbohydrate moiety, which was also shown by band shift experiments using various glycosidases. Electrophoretic and gel permeation studies showed that GMP has an apparent molecular weight of 63 kDa composed of possibly two subunits of 25 kDa containing carbohydrate moiety. GMP showed an anticomplementary activity on the hemolysis of red blood cells, which is a screening tool for inflammation mediator search.

• Journal of Radiopharmaceuticals and Molecular Probes
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• v.1 no.2
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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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• v.18 no.2
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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.

• The Journal of Korean Medicine
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• v.32 no.4
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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.

• Polymer(Korea)
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• v.33 no.2
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• pp.124-130
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• 2009

In presence of a polymer, the crystallization of low MW organic materials can be stopped at an intermediary step, where mesocrystals can be identified. A mesocrystal is defined as a superstructure of nanoparticles having polymer-adsorbed crystal faces on the scale of several hundred nanometers to micrometers. This study examined the effects of water soluble polymers and relevant parameters on the formation of guanosine-5'-monophosphate mesocrystals. It was observed in OM and SEM that GMP obtained in a polymer solution had a unique particle morphology different from the typical one of GMP. XRD analysis indicated that the polymer-directed crystallized GMP had a different polymorph of GMP. This result shows that the crystal structure of GMP can be changed by polymers. It was observed in TGA analysis that the polymer-directed crystallized GMP had a different water content, indicating a different type of hydrate.

• Design & Manufacturing
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• v.2 no.6
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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.