Regulations on Good Hygiene Practice for Food Article 38
Food additive operators shall comply with the following provisions regarding their manufacturing process and quality control:1.Standard operating procedures for the manufacturing process and quality control shall be established and fully documented.2.Each batch of finished products shall be verified to meet its quality assurance requirements. For non-compliant products, appropriate handling procedures shall be implemented and documented.3.Finished products shall comply with the Standards for Specification, Scope, Application and Limitation of Food Additives and shall be fully packaged and labeled.4.When products are sold to direct purchasers other than natural persons, information or records that enable traceability shall be maintained.
中文原文 食品良好衛生規範準則第38條
食品添加物業者，其製程及品質管制，應符合下列規定：
一、建立製程及品質管制標準作業程序，並應完整記錄。
二、每批成品應確認符合其品保要求；不符合者，應有適當處理程序，並作成紀錄。
三、成品應符合食品添加物使用範圍及限量暨規格標準，並完整包裝及標示。
四、產品銷售予非自然人之直接買受者，應有得追蹤其流向之資料或紀錄。
一、建立製程及品質管制標準作業程序，並應完整記錄。
二、每批成品應確認符合其品保要求；不符合者，應有適當處理程序，並作成紀錄。
三、成品應符合食品添加物使用範圍及限量暨規格標準，並完整包裝及標示。
四、產品銷售予非自然人之直接買受者，應有得追蹤其流向之資料或紀錄。