• 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).

• Korea Trade Review
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• v.47 no.5
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• pp.95-113
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• 2022

Tariffs on pharmaceuticals are generally low, but the time-consuming and costly licensing procedures of importing countries may act as barriers to trade. Accordingly, in terms of improving export competitiveness through cost reduction of exporting countries and improving public health for importing countries, international regulatory collaboration is effective for both countries. However, little is known about the impact of cross-border cooperation in pharmaceutical regulation on international trade. This study empirically analyzed the effect of cross-border regulatory collaboration on pharmaceutical trade using the gravity model. It was confirmed that the regulatory collaboration measures had a trade promotion effect in all drugs(HS29+HS30), finished drugs (HS30), and vaccines (HS300220). This study is meaningful in that it empirically analyzed with the consideration of the reference pharmacopoeia, safety and effectiveness in addition to the GMP inspection used in the previous study.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.19 no.5
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• pp.389-398
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• 2018

An MRA is considered to be an important policy tool within the WTO for overcoming technical barriers to trade. A number of studies on the economic impact of MRAs have demonstrated their positive economic effects. However, no studies have been conducted on MRAs in the pharmaceutical industry since analysis has been limited to industries as a whole or certain industries where some data were accumulated. Therefore, this paper analyzed the economic impact of MRAs for GMP inspection exemption in the pharmaceutical industry through the Conditional Valuation Method (CVM), a valuation technique for non-market goods. Pharmaceutical companies were asked whether or not they were willing to pay for the Korea-EFTA MRA through double-bounded dichotomous choice (DBDC) questions. The final WTP was estimated using the utility difference model developed by Hanemann (1984). As a result, annual economic effects on the pharmaceutical industry were estimated to be between KRW7.03 billion to KRW15.8 billion.

• Journal of Veterinary Clinics
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• v.35 no.1
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• pp.1-6
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• 2018

This study reviewed the regulatory safety management system for prevention of side effects of veterinary medical devices in Korea based on data obtained through analyses of those medical devices. In order to ensure the safety of medical devices, Ministry of Food and Drug Safety has established the management system include licensing, test inspection (134 designated clinical trial agencies) and post management. In addition, it was introduce the good manufacture practice (GMP) certification system and device tracking requirements. In contrast, it is necessary to establish regulations for side effects report and awareness on veterinary medical devices in Korea. The center for veterinary medicine of FDA in the United States has been operated side effects reporting system of veterinary medical devices from user, manufactures and distributor. Due to increase the use of various kinds of veterinary medical devices for animals, it should be required to improve regulation related to the licensing procedures, GMP system, and the side effects reporting system in our country.

• Proceedings of the Korean Institute of Electrical and Electronic Material Engineers Conference
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• 2010.06a
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• pp.41-41
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• 2010

In this research, to study tungsten carbide alloy(Co 0.5%) ultra precision turning possibility that is used Glass Molding Press(GMP) using conventional (Rake angle $-25^{\circ}$) single crystal diamond bite observed machining surface condition, surface roughness($R_a$), diamond bite cutting edge after tungsten carbide alloy ultra precision turning. Suggested and designed optimum chamfer bite shape to suggest ultra precision optimum bite using Finite Element Analysis(FEM). After machining tungsten carbide alloy ultra precision turning using optimum chamfer bite and comparing with conventional bite machine result and studied optimum chamfer bite design inspection and also tungsten carbide ultra precision turning possibility for high temperature compression glass lens molding.

• Journal of Pharmaceutical Investigation
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• v.37 no.6
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• pp.329-338
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• 2007

The quality assurance issue of drug products is more important than the general product because it is highly related to the human health and life. In this reason, the regulatory guide lines have continuously been intensified all around the world. In order to achieve effective quality assurance and real-time product release (RTPR) of drug products, process analytical technology (PAT), which can analyze and control a manufacturing process, has been proposed from the United States. With the PAT process, we can obtain significant process features of materials, quality characteristics and product capabilities from a raw material to the final product in the real-time procedure. PAT can also be utilized to process validation using information system that can analyze the risk of drug products through out an entire product life-cycle. In this paper, we first offered a new concept for the off-line process design methods to prepare the improved quality assurance restrictions and a real-time control method by establishing an information system. We also introduced an automatic inspection system by obtaining surrogate variables based on drug product formulations. Finally, we proposed an advanced PAT concept using validation and feedback principles through out the entire life-cycle of drug product manufacturing processes.

• Journal of the Korea institute for structural maintenance and inspection
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• v.21 no.3
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• pp.9-18
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• 2017

Construction Management at Risk (CMAR) is a project delivery method that enables CM companies to deliver projects at a Guaranteed Maximum Price (GMP). General contractors can apply CMAR from the initial design phase right through the construction phase to reduce risks and improve project performance. One of the major advantages CMAR offers is that it permits a general contractor to provide a comprehensive suite of preconstruction services, including estimating, a constructability review, value engineering, drawings and a specification review, green building, and Building Information Modeling(BIM), among others. However, general contractors in South Korea currently provide only limited preconstruction services using CMAR because few CMAR projects have yet been implemented in Korea and their experience using the method is therefore limited. This benchmark study of how foreign general contractors utilize CMAR in their projects, particularly during the preconstruction process, its purpose, and the roles and responsibilities of each of the different participants in successful implementations thus provides invaluable information and will serve as a useful guide for Korean contractors seeking to incorporate CMAR preconstruction services in their projects and thus improve the competitiveness of their construction businesses.

• Journal of Technology Innovation
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• v.28 no.4
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• pp.1-26
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• 2020

Due to the spread of Corona 19 around the world, Infectious Disease Medicine and New Medical Devices such as Diagnostic Agent are being rapidly developed and launched, and for the fast supply and demand of these, each country has eased import regulations or has implemented policies for fast approval(NIDS, 2020). On the other hand, New Developed Medical Devices that are not related to New Infectious Diseases, they are still entering the market through strict licensing and licensing regulations, such as delay and cancellation in the test inspection process, etc. Therefore, This Study specialized in the government-managed laws encountered when New Medical Devices enter the market, derive Factors influencing the Strength of Regulations, analyzes the Strength of Regulations, and proposes a Regulatory Response Framework. The Research Method was conducted by Literature Research, was applied by Failure Mode and Effects Analysis(FMEA) Method, Expert Interview(1st): Idea Collection, Expert Interview(2nd): Validation, and Priority through the Application Process of FMEA Method. A Method of Quantifying the Intensity of Regulation was proposed by multiplying the Impact of the Influencing Factors for each stage of regulation and the Burden Impact for each type of Regulatory Affairs to find the Importance of the Regulatory Factors and multiplying the Severity of the Regulatory Impact. The Implications are that major overseas countries and the Korean government are actively responding with Special Regulatory Policies and Mitigation Policies for fast licensing of New Developed Medical Devices in accordance with Corona 19. It is expected that the direction for improvement of regulations and measures to respond to regulations will be implemented so that a more proactive and preemptive response to the regulatory process of the licensing policy for New Devices can be achieved.