Pharmaceutical Good Manufacturing Practice Regulations Article 71

Top management shall ensure that quality objectives, including those needed to meet requirements for product, are established at relevant functions and levels within the manufacturer. The quality objectives shall be measurable and consistent with the quality policy.
中文原文 藥物優良製造準則第71條
最高管理階層應確保在相關部門與階層中建立品質目標。
品質目標應包括產品符合要求、可加以量測,及與品質政策一致。

English translation for reference only; the Chinese text prevails. Not legal advice.