藥廠數據完整性符合性現況分析   全文下載

Analysis of the Current Status of Data Integrity Compliance in Pharmaceutical Manufacturers

數據完整性（Data Integrity, DI）為目前各國衛生主管機關對於藥品優良製造規範（Good Manufacturing Practice, GMP）管理最為關注的議題之一，建立並維護優良的數據管理系統以證明數據的可靠性為我國醫藥產業朝國際化發展必然面對的挑戰。衛生福利部食品藥物管理署（下稱食藥署）自106年起針對藥廠品管實驗室之數據完整性進行專案查核（1,2），以確認業者數據管理系統之有效性。本研究分析探討109年至112年查核結果，歸納品質管制實驗室數據完整性之常見缺失，研究結果可作為食藥署調整未來查核重點及協助業者釐清數據管理系統之潛在風險，並作為業者持續改善其製藥品質系統（Pharmaceutical Quality System, PQS）之參考，以保障民眾用藥之品質與安全。

Data Integrity (DI) is one of the most critical concerns for health regulatory authorities worldwide in the field of Good Manufacturing Practice (GMP) for pharmaceuticals. Establishing and maintaining a robust management system to demonstrate the reliability of data is an inevitable challenge for the internationalization of Taiwan’s pharmaceutical industry. The Taiwan Food and Drug Administration (TFDA) has initiated topic-specific inspections focusing on laboratory data integrity since 2017 to verify the reliability of the industry’s data management systems. This study analyzes and explores audit results from 2020 to 2023, summarizing common deficiencies in quality control laboratory data integrity. The findings serve as a basis for the TFDA to adjust future inspection focuses and assist pharmaceutical manufacturers in identifying potential risks in their data management systems. Moreover, it also provides a reference for the pharmaceutical manufacturers to continuously improve their Pharmaceutical Quality Systems (PQS), to further ensure the quality and safety of medications for the public.