Pharmaceutical Good Manufacturing Practice Regulations Article 76
Top management shall review the manufacturer’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.
中文原文 藥物優良製造準則第76條
最高管理階層應於規劃期間內，審查製造業者之品質管理系統，以確保其持續之適用性、適切性及有效性。
該項審查應包括評估改進之機會，及包括品質政策與品質目標在內所需之品質管理系統變更。
該項審查應包括評估改進之機會，及包括品質政策與品質目標在內所需之品質管理系統變更。