Pharmaceutical Good Manufacturing Practice Regulations Article 70

Top management shall ensure that quality policy includes the following:(1) Purpose that is appropriate for and conforms to the manufacturer;(2) Commitment to comply with requirements and to maintain the effectiveness of the quality management system;(3) Framework provided for establishing and reviewing quality objectives;(4) Communication and understanding achieved within the manufacturer’s organization; and(5) Review of the suitability of quality policy.
中文原文 藥物優良製造準則第70條
最高管理階層應確保品質政策包括下列事項:
一、適當並符合製造業者之目的。
二、符合要求並維持品質管理系統有效性之承諾。
三、提供建立與審查品質目標之架構。
四、在製造業者組織內溝通並獲得瞭解。
五、審查品質政策之適用性。

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