A Study Of Current Good Manufacturing Practice (cGMP) Execution Methods - An Example Of Purify Water System Validation

• Main Authors: Chin-Jen Cheng, 鄭智仁
• Other Authors: none
• Format: Others
• Language: zh-TW
• Published: 2007
• Online Access: http://ndltd.ncl.edu.tw/handle/47711006923697565789

碩士 === 逢甲大學 === 工業工程與系統管理學研究所 === 95 === The drugs primarily focused on providing mankind with diagnosing disease, therapy, reducing a symptom or preventing disease. It is related to birth, aging, disease and death of human beings. Its quality affects the health of consumers directly. In order to insure the drugs safe, effective, stable, accurate, uniform, convenient and non-misapplication, pharmaceutical industry has to strictly control the drugs from R&D, manufacturing to marketing. Therefore, to insure medicine safety, government always takes tight control the pharmaceutical industry by regular audit, registration and GMP fellow-up inspection. Water is the most useful and important substance for pharmaceutics manufacturing. Water is used as raw materials, drug components and finished products. Safety of water is the fundamental of drug safety. The objective of this paper to study the procedure of qualification, validation and monitoring of purified water system in pharmaceutical industry. From case study, some conclusions are summarized as below. 1.Executing qualification and validation of purified water system relies on the validation master protocol and the correction of deficiency. 2.Water consumption in pharmaceutical industry is the key factor for medicine safety. The purified water system should be operated with standard operation procedure (SOP) and keep daily records. Daily reports of verify correction should be traced as the trend of the water quality. 3.A cGMP pharmaceutical company manufactures consistency products through qualification and validation of both hardware and software. However, both hardware and software are controlled by workers and consistency and efficiency of the system are also monitored by workers. The training and re-education of employee are the most important tasks for cGMP implementation.