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KMID : 1142220230180010037
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Regulatory Research on Food, Drug & Cosmetic
2023 Volume.18 No. 1 p.37 ~ p.43
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Comparative Study on the Pharmaceutical Quality Management by Company Age
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Lim Jeong-Deok
Lee Sang-Won
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Abstract
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In this study, to study the correlation between company age and drug quality management, it was conducted based on FDA GMP Inspection data and points conducted in the United States from 2009 to 2021 and was classified into three companies: 1~10 years, 11~20 years, and 21~30 years depending on the age of the company. First, as the inspection evaluation grade, the proportion of NAI to the number of inspection cases was the lowest at 35.61% for 1~10 years companies. On the other hand, OAI was the highest in 1~10 years companies with 13.93%, and the number of points compared to the number of inspection was 248.69%, indicating that 1~10 years companies accounted for the highest proportion. There was no significant difference in VAI compared to the number of inspection cases, and 21~30 years companies were the lowest at 47.88%. As a detail of this, companies with lower company age showed prominent vulnerabilities in four categories: Personnel responsibilities, Design and construction features, Control of microbiological contamination and Packaging and labeling operations. Detailed reasons for this were found to be inadequate irrigation, inadequate environmental monitoring and cleaning systems, inadequate procedures to maintain aseptic conditions, and inadequate packaging and labeling procedures. For companies with high age, there were three common weaknesses: Control of Components and Drug Product Containers and Closures, Sampling and testing of in-process materials and drug products and general requirement for Records and Reports. It was found that the detailed reasons for this were insufficient related procedures and did not follow the procedures properly. Companies whose quality is not properly guaranteed are difficult to survive in the pharmaceutical industry. It is necessary to thoroughly prepare for inspection by supplementing weaknesses in the quality control sector.
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KEYWORD
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Pharmaceutical Quality Management, Company Age, FDA GMP Inspection, cGMP
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