Pharmaceutical Good Manufacturing Practice Regulations Article 31
Chinese herbal medicine factories shall establish in writing process control procedures; aforesaid procedures shall be approved by the quality control department. Where actual operations deviate from documented procedures, aforesaid deviation shall be recorded, a determination of how to handle the deviation shall be made, and an explanation shall be given.
中文原文 藥物優良製造準則第31條
中藥廠應訂定製程管制之書面作業程序，並經品質管制部門核定。
實際管制作業與書面程序有偏差者，應加以記錄，並作合理判定及說明。
實際管制作業與書面程序有偏差者，應加以記錄，並作合理判定及說明。