Pharmaceutical Good Manufacturing Practice Regulations Article 95
Manufacturers shall identify design and development changes and maintain their records. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered.Records of the results of the review of above changes and any necessary actions shall be maintained.
中文原文 藥物優良製造準則第95條
製造業者應鑑別設計與開發之變更，並維持其紀錄。
應審查、查證及確認設計與開發之變更，經核准始得實施。
設計與開發變更之審查應包括評估變更對產品組成部分與已交貨產品之影響。
前項變更之審查結果及任何必要措施之紀錄應予以維持。
應審查、查證及確認設計與開發之變更，經核准始得實施。
設計與開發變更之審查應包括評估變更對產品組成部分與已交貨產品之影響。
前項變更之審查結果及任何必要措施之紀錄應予以維持。