國內GMP藥廠主題式查核－數據完整性管理現況研析

數據完整性是製藥品質系統的基礎，無論紙本或電子數據在其生命週期內皆需符合數據完整性的要求，以確保藥品的安全性、療效及品質。衛生福利部食品藥物管理署（下稱食藥署）依風險考量，自106年起迄今針對品管實驗室數據完整性的管理進行輔導與查核；另為瞭解實施現況，並以問卷調查與分析國內135家藥廠。結果顯示，我國藥廠多數具備數據完整性的觀念，且部分藥廠為確保數據完整性，亦逐步更新實驗室軟、硬體設備，並將風險評估精神納入電腦化系統管理策略；然，由於國內藥廠多為中小型企業，資源運用有限與風險概念尚未能落實，未來可研擬鼓勵與輔導相關政策。

關鍵字

優良製造規範；數據完整性

並列摘要

Data integrity (DI) serves as the foundation of pharmaceutical quality system. Data records, paper or electronic, should meet the DI requirement throughout their lifecycle to ensure the safety, efficacy, and quality of medical products. Taiwan Food and Drug Administration (TFDA), has been providing consultancy and performing data integrity inspections to the quality control laboratories of pharmaceutical manufacturers since 2017. The questionnaires, collected from 135 pharmaceutical manufacturers, were reviewed in order to assess the current status. The result indicted that most of the pharmaceutical manufacturers have the concept of DI, and some of them, in order to meet DI requirement, also updated the software and hardware gradually, and implemented risk assessment in computerized system management. Most of domestic pharmaceutical manufacturers are small or medium-sized enterprises, so that they have limited resources to execute the risk management exactly. TFDA will formulate relevant promotion policies and provide consultancy in the future.

並列關鍵字

good manufacturing practice (GMP) ； data integrity (DI)

國際替代計量

國內GMP藥廠主題式查核－數據完整性管理現況研析

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