Pharmaceutical Good Manufacturing Practice Regulations Article 38
Prior to packaging and labeling products, Chinese herbal medicine factories shall first inspect packaging and labeling materials to ensure that they are correct and suitable for use; aforesaid inspection results shall be entered into the batch manufacturing record.Packaging and labeling facilities shall be inspected prior to use to ensure that all pharmaceuticals from the previous run and packaging and labeling materials not suited to the present run have been completely removed; aforesaid inspection results shall be entered into the batch manufacturing record.During the final stage of production, products that have already been packaged and labeled shall be inspected to ensure that every container or package is correctly labeled.
中文原文 藥物優良製造準則第38條
中藥廠於包裝及標示作業前,應檢查包裝材料或標示材料是否正確及適用,並將結果登錄於批次製造紀錄。
包裝及標示設備,應在使用前加以檢查,以確定前次操作之藥品及不適合本批次操作之包裝及標示材料已完全清除,並將結果登錄於批次製造紀錄。
經包裝及標示作業之產品,於最後之操作過程中,應予檢查,以確保每一容器或包裝標示之正確性。
包裝及標示設備,應在使用前加以檢查,以確定前次操作之藥品及不適合本批次操作之包裝及標示材料已完全清除,並將結果登錄於批次製造紀錄。
經包裝及標示作業之產品,於最後之操作過程中,應予檢查,以確保每一容器或包裝標示之正確性。