Pharmaceutical Good Manufacturing Practice Regulations Article 55
Where Chinese herbal medicine factories have not yet established validated manufacturing processes for Chinese herbal medicine for use in clinical trials, or have not yet established comprehensive manufacturing control standards, aforesaid factories shall establish in writing operational procedures and keep detailed and accurate records for each batch of products manufactured and each batch of raw material used. Batch manufacturing records shall be kept until clinical trials are completed, or until at least two years after the product is completed, whichever period is longer.
中文原文 藥物優良製造準則第55條
中藥廠對於臨床試驗用藥之製造程序，如尚未確效或未訂定完整之製造管制標準書者，其每批產品之製造過程及原物料之使用，應訂定書面作業程序，並詳實記錄。
批次製造紀錄，應於臨床試驗完成或於產品完成後，保存至少二年，二者以期間較長者為準。
批次製造紀錄，應於臨床試驗完成或於產品完成後，保存至少二年，二者以期間較長者為準。