Pharmaceutical Good Manufacturing Practice Regulations Article 83
Manufacturers shall determine and manage the work environment needed to achieve conformity to product requirements, including adopting the following measures:(1) Manufacturers shall establish documented requirements for health, cleanliness and clothing of personnel if contact between such personnel and the product or work environment could adversely affect the quality of the product.(2) If work environment conditions can have an adverse effect on product quality, manufacturers shall establish documented requirements for the work environment conditions and documented procedures or work instructions to monitor and control these work environment conditions.(3) Manufacturers shall ensure that all personnel who are required to work temporarily under special environmental conditions within the work environment are appropriately trained or supervised by a trained person.(4) If appropriate, manufacturers shall establish documented special arrangements for the control of contaminated or potentially contaminated product in order to prevent contamination of other product, the work environment or personnel.
中文原文 藥物優良製造準則第83條
製造業者應決定並管理符合產品要求所需之工作環境，包括採取下列措施：
一、如人員與產品或作業環境之接觸會導致產品品質有不利影響，製造業者應建立對人員健康、清潔及服裝之書面要求。
二、如工作環境條件對產品品質產生不利影響，製造業者應建立工作環境條件書面要求，及監管與管制這些工作環境條件之書面程序或作業說明。
三、製造業者應確保所有在特殊環境條件下工作之臨時人員，接受必要之訓練或在訓練有素人員監管下工作。
四、適當時，為防止對其他產品、工作環境或人員造成污染，製造業者應以書面建立管制受污染或易受污染之產品之特殊安排。
一、如人員與產品或作業環境之接觸會導致產品品質有不利影響，製造業者應建立對人員健康、清潔及服裝之書面要求。
二、如工作環境條件對產品品質產生不利影響，製造業者應建立工作環境條件書面要求，及監管與管制這些工作環境條件之書面程序或作業說明。
三、製造業者應確保所有在特殊環境條件下工作之臨時人員，接受必要之訓練或在訓練有素人員監管下工作。
四、適當時，為防止對其他產品、工作環境或人員造成污染，製造業者應以書面建立管制受污染或易受污染之產品之特殊安排。