Risk Management of Medicine Mixed up for Changes in Modern Pharmaceutical Manufacturing

สุทธีสา เกตุสุริยงค์; Sutteesa Getsuriyong; จิตรา รู้กิจการพานิช; Jittra Rukijkanpanich;
Date: 2557-09
Abstract
The pharmaceutical manufacturing process must concern a quality requirement. There have been chances of mixed-up of pharmaceutical products particularly when multiple drugs were produced by using the same equipment. The mixed-up results in harmful effects on consumers and affects the image of organizations. Therefore, the objective of this research was to improve risk management system, particularly the problem associated with the mixed-up. The risk management system was conducted according to the Notification of Ministry of Public Health. In this research, two unacceptable risks (risk score equal 25) caused by human errors was found from risk assessment. Those were the main causes of the mixedup. A strict quality assurance guideline was applied in this study as a prevention measure of the mixed-up in the process of product storage and line cleaning of filling. The result showed that the level of risk was reduced to acceptable risks (risk score equal 5). Then, the prevention measure was established in all the medicine production.
Copyright ผลงานวิชาการเหล่านี้เป็นลิขสิทธิ์ของสถาบันวิจัยระบบสาธารณสุข หากมีการนำไปใช้อ้างอิง โปรดอ้างถึงสถาบันวิจัยระบบสาธารณสุข ในฐานะเจ้าของลิขสิทธิ์ตามพระราชบัญญัติสงวนลิขสิทธิ์สำหรับการนำงานวิจัยไปใช้ประโยชน์ในเชิงพาณิชย์
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