核醫藥局的品保作業

Post date: 2010/1/15 下午 02:11:50

(圖片摘自4U人際教育學院)

近年來各專科的認證滿天飛，所有步驟程序都得有SOP規範才算是跟的上時代，做的好之外，也要紀錄的好才行!

核醫藥局的市場在國內非常小，相關專業人才相對缺乏，故在規劃品保作業的工作上相對困難，先前在文件蒐尋時，找到了歐洲三年前對核醫藥局的規範，供大家參考!

其中，下列文件是建議要紀錄的:

1. Purchase and check on arrival of all ingredients and expipients
2. Purchase and check on arrival of radioactive products
3. Generator elution: activity (date, time), molybdenum-99 breakthrough and, if tested, aluminum ion breakthrough
4. Product preparation: batch numbers, activity and volume added, results of qualitycontrol and release
5. Laboratory cleaning and maintenance
6. Equipment calibration and maintenance
7. Training of personnel
8. Transport of radioactive materials
9. Radioactive contamination monitoring and radioactive waste disposal
10. Product defects and events of non-conformity to SOPs
11. Prescription of patient doses.
12. Microbiological monitoring.

看來基隆核醫要申請認證，還有取多事情得要做!