Pharmaceutical Good Manufacturing Practice Regulations Article 80

Manufacturers shall ensure their personnel performing work affecting product quality are competent on the basis of appropriate education, training, skills and experience.
中文原文 藥物優良製造準則第80條
製造業者應以適當之教育、訓練、技能及經驗為基礎,確保執行影響產品品質工作之人員得以勝任其工作。

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