國內藥廠數據完整性專案查核結果研析

A Study of the Inspection Results on Data Integrity Compliance in Domestic Pharmaceutical Manufacturers

數據完整性（Data Integrity, DI）為藥品安全及品質保證的基礎，近年來已成為國際製藥產業管理的重要議題，衛生福利部食品藥物管理署（以下簡稱食藥署）自106年起開始執行西藥工廠之「數據完整性專案查核」，本研究分析探討37件查核結果，歸納分析數據完整性各層面之常見缺失及管理要點，並評估製劑廠及原料藥廠對於數據完整性之成熟度，結果顯示原料藥廠在數據完整性之管理普遍更為成熟，本分析結果可作為協助業者釐清數據管理系統之潛在風險及持續改善其品質系統之參考，落實優良的數據管理作業。 The integrity of data is the fundamental to ensure the safety and quality of pharmaceutical products. Recently, ＂Data Integrity＂ has become an important issue of the governance in the global pharmaceutical sector. Since 2017, Taiwan Food and Drug Administration initiated a project to inspect the compliance of data integrity of domestic pharmaceutical manufacturers. In this study, we analyzed the results from the 37 inspections, identified the most frequently observed deficiencies, and outlined the key strategies for data governance practices. Furthermore, we evaluated the maturity levels of the data integrity by manufacturers of active pharmaceutical ingredients (APIs) and medicinal products. The results show manufacturers of APIs are more mature in data integrity governance. The interpretation of this study can serve as the references for manufacturers to assess their data governance system for potential vulnerabilities, continuously improve their pharmaceutical quality system and implement good data governance practices to ensure the maintenance of data integrity.