Regulations Governing Management of Manufacturing Schedule 1 and 2 Controlled Drugs Commissioned to Pharmaceutical Firms Article 10
The digital surveillance cameras and equipment and surveillance system shall meet the following criteria:1. The camera recording resolution and depth of field shall at least allow the clear facial recognition of a person.2. Maintenance shall be conducted properly. There shall be power outage prevention measures.3. The surveillance recording shall be in operation throughout the process and storage of the manufacturing of the controlled drugs, and continuous images provided with date and time displayed. Editing and reproduction are prohibited.The commissioned pharmaceutical firm shall submit the digital file of the surveillance camera recording to the FDA along with the delivery of each batch.
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10條
前條數位監視錄影設備及監視系統，應符合下列規定：
一、錄影畫面解析度及景深，至少達到清晰辨識人員臉部外觀之程度。
二、妥善維護，並具有防止斷電措施。
三、受託製造管制藥品之作業及儲存期間，全程錄影，其畫面連續完整，並顯示日期、時間，且無剪接或重製情事。
受託藥商應將監錄所得之數位檔案，於每批產品交貨時，併交付予食品藥物署。
一、錄影畫面解析度及景深，至少達到清晰辨識人員臉部外觀之程度。
二、妥善維護，並具有防止斷電措施。
三、受託製造管制藥品之作業及儲存期間，全程錄影，其畫面連續完整，並顯示日期、時間，且無剪接或重製情事。
受託藥商應將監錄所得之數位檔案，於每批產品交貨時，併交付予食品藥物署。