Pharmaceutical Good Manufacturing Practice Regulations Article 93
Manufacturers shall perform verification in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained.
中文原文 藥物優良製造準則第93條
製造業者應依據所規劃之安排對設計與開發進行查證，以確保設計與開發輸出符合設計與開發輸入之要求。
查證結果及任何必要措施之紀錄應予以維持。
查證結果及任何必要措施之紀錄應予以維持。