现场注册核查应对

gaowenhua

核对各参数与现行清洁SOP的一致性，以及现场操作的一致性，如清洁方式、清洁剂、存放时限等

gaowenhua

Verify the consistency of each parameter with the current cleaning SOP, as well as the consistency of on-site operations, such as cleaning methods, cleaning agents, storage time limits, etc

gaowenhua

使用的原辅料应账物一致，如有结余，物料应保留，如使用完，应与台账一致。

gaowenhua

The raw materials used should be consistent with the accounts. If there is any surplus, the materials should be retained. If used up, they should be consistent with the accounts.

gaowenhua

生产设备和检测设备的记录均应与生产和检测的批记录进行核对，日期、时间、批号、数量等信息，切记不可出现逻辑性错误

gaowenhua

The records of production equipment and testing equipment should be checked against the batch records of production and testing, including date, time, batch number, quantity, and other information. It is important to remember that there should be no logical errors

gaowenhua

核对技术转移的分析方法内的方案、记录、报告的一致性，方法与文件的一致性

gaowenhua

Verify the consistency of plans, records, and reports within the analysis methods for technology transfer, and the consistency of methods and documents

gaowenhua

试制生产的产品，稳定性考察剩余的样品，留样样品等，一切涉及产品对应的样品均应完整保留

gaowenhua

Products produced through trial production, stability testing, remaining samples, retention samples, etc. All samples related to the product should be fully retained