Pharmaceutical Good Manufacturing Practice Regulations Article 92
Manufacturers shall, at suitable stages, perform systematic reviews of design and development in accordance with planned arrangements and comply with the following requirements:(1) Evaluating the ability of the results of design and development to meet requirements; and(2) Identifying any problems and propose necessary actions.Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed, as well as other specialist personnel.Records of the results of the reviews and any necessary actions shall be maintained.
中文原文 藥物優良製造準則第92條
製造業者應於適當階段，依據所規劃之安排執行設計與開發系統性審查，並符合下列規定：
一、評估設計與開發結果符合要求之能力。
二、鑑別任何問題並提出必要措施。
參與審查者應包括與接受設計與開發階段相關部門代表和其他技術人員。
審查結果及任何必要措施之紀錄應予以維持。
一、評估設計與開發結果符合要求之能力。
二、鑑別任何問題並提出必要措施。
參與審查者應包括與接受設計與開發階段相關部門代表和其他技術人員。
審查結果及任何必要措施之紀錄應予以維持。