Pharmaceutical Good Manufacturing Practice Regulations Article 42
Chinese herbal medicine factories shall establish in writing quality department duties and operational procedures; aforesaid duties and procedures shall include the following items:(1) Examination of approval, non-approval and manufacturing records for all raw materials, product containers, caps, semi-finished or intermediate products, packaging materials, labeling materials and products;(2) Examination of operational procedures specifications that affect product ingredients, contents, quality and purity;(3) Inspection of facilities used in the testing of raw materials, product containers, caps, semi-finished or intermediate products, packaging materials, labeling materials and products;(4) Establishment in writing of operational procedures governing the calibration of instruments, devices, meters and recording apparatuses; aforesaid procedures shall clearly prescribe calibration methods, schedules, accuracy limits, as well as usage restrictions and remedial measures for items that do not comply with accuracy limits;(5) Establishment in writing of operational procedures governing sample quantities, test intervals and test methods for product stability testing.
中文原文 藥物優良製造準則第42條
中藥廠應以書面訂定品質管制部門之職責及作業程序，並包括下列事項：
一、審核所有原料、產品容器、封蓋、半製品或中間產品、包裝材料、標示材料與產品之准用或拒用及製造紀錄。
二、審核影響產品成分、含量、品質及純度之作業程序或規格。
三、審核原料、產品容器、封蓋、包裝材料、半製品或中間產品及產品之檢驗設施。
四、訂定有關儀器、裝置、儀表及記錄器之校正書面作業程序，明確規定校正方法、日程表、精確度界限與未能符合精確度界限時之限制使用及補救措施。
五、訂定與產品安定性試驗有關之取樣數量、試驗間隔及試驗方法之書面作業程序。
一、審核所有原料、產品容器、封蓋、半製品或中間產品、包裝材料、標示材料與產品之准用或拒用及製造紀錄。
二、審核影響產品成分、含量、品質及純度之作業程序或規格。
三、審核原料、產品容器、封蓋、包裝材料、半製品或中間產品及產品之檢驗設施。
四、訂定有關儀器、裝置、儀表及記錄器之校正書面作業程序，明確規定校正方法、日程表、精確度界限與未能符合精確度界限時之限制使用及補救措施。
五、訂定與產品安定性試驗有關之取樣數量、試驗間隔及試驗方法之書面作業程序。