Regulations for Medicament Contract Manufacture and Analysis Article 13
The contract party and the contract inspector shall enter into a contract analysis agreement, which shall include matters related to the scope of contract analysis, an operation plan, and the standard operating procedures.
中文原文 藥物委託製造及檢驗作業準則第13條
委託者與受託者應訂立委託檢驗契約,列明其委託檢驗範圍之相關事項、作業計畫書及標準作業程序。