Pharmaceutical Good Manufacturing Practice Regulations Article 114
As one of the measurements of the performance of the quality management system, manufacturers shall monitor information relating to whether they have met customer requirements.Manufacturers shall determine the methods for obtaining and using this information.Manufacturers shall establish a documented procedure for a feedback system to provide early warning of quality problems and for input into the corrective and preventive action processes.Manufacturers shall gain experience from the post-production phase in accordance with the regulations of central competent health authority, and the review of this experience shall form part of the feedback system.
中文原文 藥物優良製造準則第114條
製造業者應對有關其是否已符合顧客要求之資訊進行監管以作為對品質管理系統績效之量測之一。
製造業者應決定獲取與利用該等資訊之方法。
製造業者應建立書面之回饋系統以提供品質問題之早期警示，且能輸入矯正與預防措施流程。
製造業者應依中央衛生主管機關規定從生產後階段獲取經驗，並構成回饋系統之一部分。
製造業者應決定獲取與利用該等資訊之方法。
製造業者應建立書面之回饋系統以提供品質問題之早期警示，且能輸入矯正與預防措施流程。
製造業者應依中央衛生主管機關規定從生產後階段獲取經驗，並構成回饋系統之一部分。