Pharmaceutical Good Manufacturing Practice Regulations Article 18
The production capacities of mechanical facilities used at Chinese herbal medicine factories to produce a single product shall be carefully coordinated to ensure consistency of product quality.Automated machinery and electronic facilities used in the manufacturing process, as well as software and equipment related to computers or to the manufacture, processing, re-packaging, packaging or storage of pharmaceuticals, shall be regularly recalibrated, inspected, examined and maintained.Computer systems used to control production and production management records shall be properly maintained, and alterations may not be made to aforesaid systems without permission from the personnel in charge; all data that is input or printed shall be checked for accuracy, and its period of validity shall be determined based on the complexity and reliability of the computer system.Air used by drying facilities during the manufacturing process shall first be treated with a purification filter.Facilities used to manufacture pharmaceuticals for internal and external use shall be kept strictly separate, and may not be used interchangeably.Pharmaceutical factories shall install weighing facilities that comply with regulations, and shall recalibrate aforesaidfacilities regularly.
中文原文 藥物優良製造準則第18條
中藥廠用於製造同一產品過程之器械設備，其生產能量應相互配合，以利產品品質均一。
製造過程所使用之自動機械、電子裝備及其他有關電腦或週邊有關製造、加工、分裝、包裝或儲存藥品之軟體及設備，應依既定計畫予以定期校正、巡視、檢查，並存檔維護。
以電腦系統控制有關主要生產及其管理紀錄者，應善加維護，非經有關權責人員同意，不得變更；其所有資料之輸入及列印，應檢查其精確性，並依電腦系統之複雜性及可信度決定其確效週期。
用於製造過程中乾燥設備之空氣，應先經清淨過濾裝置之處理。
製造內服與毒劇外用藥品之設備，應嚴格區分，不得互為挪用。
中藥廠應設置符合規定之秤量設備，並定期校正。
製造過程所使用之自動機械、電子裝備及其他有關電腦或週邊有關製造、加工、分裝、包裝或儲存藥品之軟體及設備，應依既定計畫予以定期校正、巡視、檢查，並存檔維護。
以電腦系統控制有關主要生產及其管理紀錄者，應善加維護，非經有關權責人員同意，不得變更；其所有資料之輸入及列印，應檢查其精確性，並依電腦系統之複雜性及可信度決定其確效週期。
用於製造過程中乾燥設備之空氣，應先經清淨過濾裝置之處理。
製造內服與毒劇外用藥品之設備，應嚴格區分，不得互為挪用。
中藥廠應設置符合規定之秤量設備，並定期校正。