Regulations Governing Management of Manufacturing Schedule 1 and 2 Controlled Drugs Commissioned to Pharmaceutical Firms Article 12
During the period of the commissioned manufacturing of the controlled drugs, the FDA shall appoint a representative to supervise the commissioned pharmaceutical firm on a daily basis.The appointed representative shall perform the following duties:1. After a production phase of the batch is completed and before the subsequent process starts, sign in the corresponding fields of the “Manufacturing Instruction and Records” and other forms jointly with the representative appointed by the commissioned pharmaceutical firm.2. Supervise the commissioned pharmaceutical firm finishing the cleaning of equipment and containers contacting the drugs immediately on the day the process has been completed.3. Finish the cleaning and records jointly with the supervisor of the commissioned pharmaceutical firm appointed under Subparagraph 5, Article 6.The commissioned pharmaceutical firm shall cooperate with, and shall not circumvent, interfere with, or reject, the supervising by the person designated by the FDA.
中文原文 藥商受託製造第一級及第二級管制藥品管理辦法第12條
食品藥物署於委託製造藥品實際製造期間，應每日派員至受託藥商監督。
前項所派人員，應執行下列事項：
一、於每批產品各階段製程完成後，後續作業進行前，會同受託藥商指定之作業負責人，於「製造指示及紀錄」及其他表單相對應欄位簽核。
二、監督受託藥商於作業完成當日，立即完成與藥品接觸之設備、容器之清潔工作。
三、依第六條第五款會同監督受託藥商作業人員完成清洗、記錄。
食品藥物署所派人員之監督，受託藥商應予配合，不得規避、妨礙或拒絕。
前項所派人員，應執行下列事項：
一、於每批產品各階段製程完成後，後續作業進行前，會同受託藥商指定之作業負責人，於「製造指示及紀錄」及其他表單相對應欄位簽核。
二、監督受託藥商於作業完成當日，立即完成與藥品接觸之設備、容器之清潔工作。
三、依第六條第五款會同監督受託藥商作業人員完成清洗、記錄。
食品藥物署所派人員之監督，受託藥商應予配合，不得規避、妨礙或拒絕。