103-105年度食藥署非臨床GLP認證機構品質評估研究   全文下載

Evaluation of the Quality of TFDA-Accredited Non-Clinical GLP Testing Facilities in 2014-2016

為瞭解國內15家經食品藥物管理署（以下簡稱食藥署）認證非臨床試驗優良操作規範（GLP）試驗機構之品質，食藥署逐年依照前衛生署公布之「藥物非臨床試驗優良操作規範」辦理認證試驗機構之實地查核。本研究統計並分析103至105年度之實地查核種類及缺失，並依上述規範之章節進行分類，探討認證試驗機構常見的缺失項目。統計結果顯示三年期間共計查核24場次，實地查核場次逐年上升；另三年期間共計開出176項缺失，其中第七章「試驗計畫書及試驗之執行」缺失數目49項最多，其次為第五章「試驗機構之操作」36項缺失、第二章「組織與人事」34項缺失、第四章「設備」及第八章「紀錄與報告」各25項缺失。上述缺失認證試驗機構均完成改善，且亦未發現認證試驗機構有嚴重違反GLP、數據造假等情事，顯示食藥署GLP認證試驗機構於進行非臨床試驗，具有一定之水準。本研究實地查核的結果，除列為食藥署加強監督管理認證試驗機構之評估外，並供試驗機構持續改進品質之參考。

In 2014-2016, fifteen TFDA-accredited non-clinical Good Laboratory Practice (GLP) testing facilities underwent in situ inspections to validate the quality of their work. In total, 24 in situ inspections were performed over the three years, with an increase in the number of inspections each year. A total of 176 non-conformance reports (NCR) were obtained. The most frequent NCRs were related to Chapter 7 “Protocol and Conduct of a Nonclinical Laboratory Study” (49 NCRs), followed by Chapter 5 “Testing Facilities Operation” (36 NCRs). The inspectors also found 34, 25 and 25 NCRs in Chapter 2 “System Management and Personnel”, Chapter 4 “Equipment” and Chapter 8 “Record and Final Report”, respectively. All the NCRs were subsequently corrected by the testing facilities and no serious violation of the GLP or fraudulent data was observed, indicating that the accredited facilities met a certain standard of quality. The results of the inspections serve to enhance the supervision and management of the accredited testing facilities, as well as provide them with references to continuously improve the quality of their work.