Regulations on Good Practices for Drug Dispensation Article 41
A medical institution or pharmacy that performs sterile compounding shall establish standard operating procedures for the following matters regarding its sterile compounding areas and sterile laminar airflow workbenches respectively, and implement them in accordance with the prescribed procedures:1. Airborne particle monitoring.2. Microbiological monitoring.3. Environmental cleaning and disinfection.When a medical institution or pharmacy implements the matters as described in the preceding Paragraph, the records shall be made accordingly and be kept for at least three years in writing or electronic form.
中文原文 藥品優良調劑作業準則第41條
醫療機構或藥局執行無菌調製，應就其調製作業區域及無菌層流操作臺之下列事項，分別訂定標準作業程序，並依所定程序執行之：
一、空氣懸浮粒子監測。
二、微生物監測。
三、環境清潔及消毒。
醫療機構或藥局執行前項事項，應製作紀錄，至少保存三年，並以書面或電子化方式為之。
一、空氣懸浮粒子監測。
二、微生物監測。
三、環境清潔及消毒。
醫療機構或藥局執行前項事項，應製作紀錄，至少保存三年，並以書面或電子化方式為之。