An Optimized Study on the Aseptic Pharmaceutical Factory Environmental Monitoring

• Main Authors: HUNG, YU-SHIANG, 洪郁翔
• Other Authors: HU, HSIU-HUA
• Format: Others
• Language: zh-TW
• Published: 2019
• Online Access: http://ndltd.ncl.edu.tw/handle/j3h8xf

碩士 === 銘傳大學 === 國際企業學系碩士在職專班 === 107 === The establishment of the environmental monitoring system of the pharmaceutical factory is based on the regulations formulated by the national health authorities or organizations. Good Pharmaceutical Manufacturing Practice PIC/S GMP is intended to regulate pharmaceutical factories to be able to produce and control according to product quality standards, to achieve stable and continuous supply of safe and effective drugs. Therefore, environmental monitoring is an important cornerstone of quality assurance in the manufacturing process. Through the direction and method of national regulations or literature, the data integrity category and the background conditions of the pharmaceutical industry itself, this study designs a set of environmental monitoring strategies that are in line with international regulations, including environmental sampling location assessment plans and environmental microbial growth trend analysis. The microbiological investigation procedure and the process of establishing a strain database; the strategy is to effectively reduce or eliminate pollutants in the air quality of the production environment or potential clean room, such as microorganisms and endotoxins. How to use an efficient way to evaluate, analyze and formulate various systems or levels depends on the organization and division of labor, and has a forward-looking and effective environmental monitoring optimization system to ensure the quality of pharmaceutical products and improve the pharmaceutical industry. Competitive advantage in the biotechnology industry.