cgmp文件-藥典對照品的接收、儲存、使用和保管程序sop(編輯修改稿)
2025-10-04 06:22 本頁面
【文章內容簡介】 ial and usage record (As per AnnexureII) should be issued for use.，前一瓶使用完后，接著再發(fā)放下一瓶，并在如附件II所示的《對照品使用記錄》中登記。Remaining vials should be maintained as stock and after consumption of previous vial, next vial of same reference standard and ‘reference standard usage record’ as per AnnexureII could be issued for use. of reference standards 確保對照品批號是現(xiàn)行有效的批號，并且瓶中無異常情況。Ensure the reference standard is of current lot and there is no abnormality in the vial. 使用對照品應注意避免所有污染和溢出。Take all necessary precautions to avoid any contamination and spillage during using the reference standards. 打開瓶子前確保放置區(qū)域清潔且無以前樣品的殘留。Ensure the area is clean and free from traces of previous products before opening the vial. 冰箱儲存的對照品使用前應放在干燥器中升到室溫。Refrigerated vials should be allowed to equilibrate to room temperature by keeping them in desiccators before use. 打開瓶子，只取出要求數(shù)量的對照品，取出的剩余對照品應丟棄，不得倒回瓶中。Open the vial and take only required quantity of material, remaining removed material should be discarded and should not pour back to the vial. 使用完畢立即蓋緊瓶蓋并在瓶頸周圍繞上封口膜。Immediately after use, close the vial with original cap and wrap Parafilm around the neck of the vial. 分別按各自儲存條件儲存對照品。Store the vial to respective storage condition. 在附件II所示的《對照品使用記錄》中登記。
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