• Journal of Pharmaceutical Investigation
• /
• v.34 no.1
• /
• pp.57-71
• /
• 2004

The objective of this study was to provide a better understanding of SUPAC-IR and its application in handling postapproval changes to immediate release solid oral dosage forms. Originally, SUPAC-IR was aimed at reducing the regulator burdern of the industry when they were making postapproval changes, but still at maintaining the formulation quality and performance of a drug product. The postapproval changes that were covered under SUPAC-IR included variations in the components ad composition of formulation, the site of manufacturing, batch size, manufacturing equipment, and manufacturing process. The guidance defined levels of changes, based on the likelihood of risk ocurrence and potential impact of postapproval changes upon the safety and efficacy of a drug product I suggested what a type of fing report should be submitted to the FDA for each level of change. Chemist, manufacturing, and control tests to be executed were also recommended for each change level The important tests specified in the guidance included batch release, stability, in vitro dissolution, and in vivo bioequivalence tests. However, there have been strong demands on revising the current SUPAC-IR in order to resolve some issues and to improve its usefulness in evaluating postapproval changes to immediate release solid oral dosage forms. In particular, the rigorous requirement of case C dissolution test and the definition of batch size were challenged by both academia and the industry. A revision work was in progress to reflect these inputs and to expand the utility of SUPAC-IR. As a result of these concerted efforts, an updated 2nd version of SPAC-IR would be likely to be issued ver soon to the public.

• Journal of Dairy Science and Biotechnology
• /
• v.26 no.2
• /
• pp.51-56
• /
• 2008

Using central composite design, we have designed optimization of the manufacturing of processed butter. And response surface analysis by least-square regression was used Statistical Analysis System(SAS). Central composite design can be achieved by response surface techniques that allow flexibility in modeling and analysis. Response surface methodology(RSM) was used to optimize hardness(%) using as independent variables; the content of butter($X_1$), ranging from 50 to 90(%), the content of soybean oil($X_2$), from 0 to 20(%), and the hydrogenated soybean oil($X_3$) from 0 to 4(%). The results on the regression coefficients calculated for overrun by response surface by least-square regression(RSREG) were followed. It was considered that the linear regression was significant(p<0.01). As for the processed butter, the regression model equation for the hardness(Y, %) to the change of an independent variable could be predicted as follow: $Y=60.88-8.92X_2-{29.3X_2}^2$. The optimal for the manufacturing of processed butter were determined at the content of butter of 88.22%, soybean oil of 6.71% and hydrogenated soybean oil of 2.36%, respectively. Optimum compositions were resulted in hardness of 65.78 N. Finally the reference sample(Butter in the morning, Seoul Dairy Co-op.) and processed butter manufacturing under the optimal conditions were compared with spreadability test. The spreadability scores result from reference sample and butter under optimal conditions was not found a significant difference.

• Journal of Pharmaceutical Investigation
• /
• v.34 no.3
• /
• pp.229-254
• /
• 2004

The objective of this study was to scrutinize the rationale of SUPAC-MR and its application in processing postapproval changes to modified release solid oral dosage forms. The types of postapproval changes that were primarily covered with SUPAC-MR included variations in the components and composition, the site of manufacturing, batch size, manufacturing equipment, and manufacturing process. SUPAC-MR defined levels of postapproval changes that the industry might make. Classification of such categories was based on the likelihood of risk occurrence and potential impact of changes upon the safety and efficacy of approved drug products. In most cases, the changes could be classified into 3 levels. It described what chemistry, manufacturing, and control tests should be conducted for each change level. The important tests specified in SUPAC-MR were batch release, stability, in vitro dissolution, and in vivo bioequivalence tests. It then suggested what type of a filing report should be submitted to the FDA for each change level. In general, level 1 changes could be reported in an annual report, whereas level 2 and/or 3 changes could be submitted in changes-being-effected or prior approval supplements. It could be understood that the purpose of SUPAC-MR was to maintain the safety and quality of approved modified release solid oral dosage forms undergoing certain changes. At the same time, it contributed to providing a less burdensome regulatory process with the manufacturers when they wanted to make postapproval changes. European regulatory agencies also implemented SUPAC-like regulations in handling such changes to drug products. Therefore, in this study a recommendation was made for KFDA and the Korean industry to evaluate thoroughly the usefulness of these guidances and regulations in dealing with postapproval changes to modified release solid oral dosage forms.

• Korea Trade Review
• /
• v.47 no.5
• /
• pp.147-160
• /
• 2022

This study aim to use the GTAP model to analyze the impact of RCEP Fermentation in the Korean manufacturing industry by quantifying the RCEP tariff commitment table. The research results show RCEP has boosted output in all sub-manufactures except wood and printed matter due to increased export volumes. Wood products, on the other hand, are more reliant on imports due to lower production due to lower domestic sales or overall exports. After RCEP came into effect, the import and export scale of Korea's manufacturing industry expanded effectively. Among them, the positive impact on the intensive low-tech manufacturing industries such as clothing and leather products, wood products and printing products, and food, beverage and tobacco products is greater than the positive impact on the technology-intensive medium and high-tech and high-tech manufacturing industries. And found that the growth rate of Korea's manufacturing trade is basically proportional to the tax reduction rate of RCEP. Finally, in order to promote the development of the manufacturing industry, some suggestions are put forward that need the government's policy support and strengthen the regional cooperation with RCEP member countries.

• Journal of the Korean Society of Food Science and Nutrition
• /
• v.41 no.11
• /
• pp.1611-1618
• /
• 2012

Peeled balloon flower roots and parboiled bracken are pre-processed foodstuffs commonly used in the institutional food service. This study was conducted to establish the suitable manufacturing process for these foodstuffs and the optimal storage condition during distribution in the market. The most suitable manufacturing process was developed by surveying the manufacturing factories that produce these foodstuffs. Samples were collected by selecting a site among the surveyed manufacturing factories and storing them at different temperatures (4, 10, $20^{\circ}C$). The resulting changes in microbiological, physicochemical, and organoleptic qualities depending on the storage period (1, 2, 3, 4, 5, 7, 10 days) were investigated. The number of general bacteria in balloon flower roots at the beginning of the storage period was 5.26 log CFU/g and the number in the $4^{\circ}C$ storage group remained unchanged until the $3^{rd}$ day, but then increased to 7.63 log CFU/g at the $4^{th}$ day, and then gradually increased up to the $7^{th}$ day. However, in the 10 and $20^{\circ}C$ storage groups, the number was rapidly increased to 7.42 log CFU/g and 7.86 log CFU/g, respectively, at the $2^{nd}$ day. The parboiled bracken samples presented a similar trend. For physicochemical quality changes, the pH and hardness were rapidly decreased in the $20^{\circ}C$ storage group. The organoleptic quality was favorably evaluated (5~6 points out of 9 points) up to the $5^{th}$ day in the $4^{\circ}C$ storage group but the overall acceptability was rapidly decreased from the $2^{nd}$ day in the other storage temperature groups. These results confirmed the optimal storage condition for these pre-processed foodstuffs as being less than 3 days at $4^{\circ}C$.

• Journal of the Korean Society of Food Science and Nutrition
• /
• v.4 no.1
• /
• pp.7-12
• /
• 1975

• Korean Journal of Food Science and Technology
• /
• v.36 no.6
• /
• pp.1020-1025
• /
• 2004

In previous paper, contaminations of food-borne pathogenic bacteria of Saengshik was found to occur during processing, because detection rates of food-borne pathogenic bacteria in final products were higher than those of raw materials. In this study, methods to reduce food-borne pathogenic bacteria and improved manufacturing process were developed for microbial safety of Saengshik. Food-borne pathogenic bacteria in raw materials were reduced to about 0.5-2.0 log cfu/g when seven kinds of raw materials were washed with electrolyzed water and ozonated water, but food-borne pathogenic bacteria could not be removed completely. After improvement of manufacturing process, numbers of food-borne pathogenic bacteria were same or decreased to levels of raw materials. Gaseous ozone and Biocon could control air-borne bacteria under $1{\times}10^1$ cfu/1000 L of air in pulverization and mixing rooms.

• Journal of the Korean Professional Engineers Association
• /
• v.26 no.4
• /
• pp.22-29
• /
• 1993

• 축산식품과학과 산업
• /
• v.10 no.2
• /
• pp.11-18
• /
• 2021

• Journal of the Korean Society of Food Science and Nutrition
• /
• v.39 no.4
• /
• pp.554-559
• /
• 2010

The manufacturing characteristics and physicochemical components analysis of Bokbunja jelly made with the addition of different amounts of materials (Bokbunja extract, sugar, gelatin, and pectin) were investigated. There were no significant changes in the pH, total acidity and sugar content of all Bokbunja jelly prepared with different amount of materials. L-value of color in the Bokbunja jelly increased in proportion to additive amount of gelatin. a-value and b-value of color in the Bokbunja jelly increased in proportion to additive amount of pectin. The value of hardness, adhesiveness, and chewiness in the Bokbunja jelly increased in proportion to the additive amount of gelatin. The value of springiness, cohesiveness, and gumminess were increased in proportion to additive amount of petin. The highest of overall acceptability values in the sensory test for color, sweetness, springiness, chewiness, and overall favorite were 5.80, 5.32, 5.27, 5.83, and 6.02, respectively, with the addition of 10% gelatin and 10% pectin.