The Benefits and Difficulties of Implementing GMP for Medical Device Manufacturers in Taiwan

• Main Authors: SHIN LEI HUANG, 黃欣磊
• Other Authors: Wenyih Lee
• Format: Others
• Language: zh-TW
• Published: 2007
• Online Access: http://ndltd.ncl.edu.tw/handle/42015273531170135369

碩士 === 長庚大學 === 企業管理研究所 === 95 === In recent years, the medical device industry has been vigorous in Taiwan. The government regards it as the star industry of the future. The manufacturers must follow the guidance of the law to obtain the quality system certification, especially the Good Manufacturing Practice (GMP). One of the purposes of this research is to find out what the difficulties and benefits were when firms implemented GMP. To achieve this aim, a questionnaire survey was conducted. A pilot run was developed based on extensive related literature and tested for validity and reliability. All GMP manufacturers registered in Taiwan are the targets for the study. 265 questionaires were sent out and among which 32 were returned, a response rate of 12%. After analyzing the data, we found the following results: Most of the GMP manufacturers in Taiwan are small in scale and most of them are in class Π Classification. Seventy-five percent of manufacturers set up their GMP by asking consultation from outside resources. The average cost of setting up GMP is NT$ 300,000 ~ 400,000 per case. The average time spent on each case are 8.8 months. The main motivation of setting up GMP is to follow the guidance of the law. The major difficulties when implementing GMP are, in descending order, as follow: QMS efficiency work, human resource supply, design control subsystem, to know the hygiene law, and corrective and preventive action (CAPA). The most unsatisfied aspect in GMP certification is the processing time at Department of Health. The highest perceived benefits are making enterprise image better and increasing customers’ satisfaction. There is significant difference between business scale and the way of setting up GMP. The same is in maintanance.　 There is positive correlation between classification and the dissatisfaction in the professional performance of the auditor. There is positive correlation between other quality management system being set up and the dissatisfaction in the professional perfomance and fairness of the auditor when conducting GMP auditing. There is positive correlation between the difficulty of beginning stage in GMP and dissatisfaction in auditing. There is positive correlation between dissatisfaction in auditing and dissatisfaction in GMP benefits evaluated. It is recommended that manufacturers, consultants and the government would pay attention to the difficulties and could provide resources to help firms successfully implement GMP.