现场注册核查应对

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在对应生产线上产品从中试批至验证批至现场检查时所有生产的品种清单，涵盖名称、规格、批号、批量

                               
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A list of all varieties produced on the corresponding production line, from pilot batch to validation batch to on-site inspection, covering name, specifications, batch number, and batch size

                               
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相应品种的质量标准、检验规程、工艺规程、质量管理、设备管理差等文件；如产品在历史过程中，有工艺或质量标准的变更，而导致文件发生升版，那么历次版本的原始文件得调取出来。

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The quality standards, inspection procedures, process procedures, quality management, and equipment management documents for the corresponding varieties; If there are changes in the process or quality standards of the product in the historical process, resulting in file upgrades, the original files of previous versions must be retrieved

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核对相应的变更工作、偏差以及OOS实施情况

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Verify the corresponding change work, deviations, and OOS implementation status

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所有纸质数据与电子数据均应逐一核对；如出现中断，应有偏差或在台账上有记载具体原因，可追溯

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All paper data and electronic data should be checked one by one; If there is an interruption, there should be a deviation or specific reasons recorded in the ledger, which can be traced back

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工艺验证方案，记录，报告；灭菌工艺验证方案，记录，报告。

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Process validation plan, records, reports; Sterilization process validation plan, records, and reports.