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- Product Batch Records 生产批号记录
- To file the batch record in the GMP library termly. 将批记录定期归档在GMP图书馆。
- Dispense, audit, monitor the batch records according to the plan. 依照生产计划进行批记录的发放、审核和监控。
- All tests and results should be fully documented as part of the batch record. 所有的检测和结果应全部记录作为批记录的部分。
- The retention Samples of the Drug Product must be stored at the Site that releases the Drug Product Batch. 制剂产品的留样必须保存在放行制剂产品批的工厂。
- Every product batch is thoroughly tested on site to ensure that they meet the high demands of our quality management. 每一批产品都在现场接受彻底的检测以确保其质量符合我们的质量管理要求。
- In this situation a Q.P. of the purchaser should certify the finished product batch before release. 这种情况,采购方的Q.;P
- Packing mark include : product type, mass, product batch, checker number, net weight, total weight. 包装外标识内容包括:型号、数量、生产批号、检验工号、毛重及净重。
- Documentation.Fill in the information for batch record, logbook and other record. 文件完整,准确和及时地填写批次记录,日志和其他记录。
- Receive and archive the production documentation, including the Batch Record and COA. 及时准确接收、存入各种与生产有关原始记录。
- Batch records electronically stored should be protected by back-up transfer on magnetic tape, microfilm, paper or other means. 以电子方式储存的批记录应有备份,如磁带,缩微胶片,纸张或其他手段。
- Part of a finished product batch is imported after another part of the same batch has previously been imported to the same or a different site. 某一批次成品的一部分继该批次另一部分之后进口到相同或不同的厂址。
- This information is usually separate from conventional batch records and so would not necessarily be reviewed by the trend analysis program. 这个信息通常是和常规的批记录分开的,因此不需要被趋势分析程序回顾。
- Documentation Management, In charge of release document and batch record filing. 文件管理,负责放行文件, 原始纪录的整理归档。
- These systems employ unique identification tags that are printed or attached to the product packaging which enable each product batch to be differentiated. 这两个验证方法都使用印或贴在食品包装上的独特的认证标签,通过标签可以区分不同批次的产品。
- In this article, we modify the mathematical model for design of single product batch plants and present a heuristic procedure, including equipment sizing and process synthesis. 本文修正了单产品间歇化工过程设计的数学模型并提出该问题的启发算法,该算法包括设备尺寸计算与过程综合。
- Prior to use, production personnel should verify that the materials are those specified in the batch record for the intended intermediate or API. 在使用前,生产人员应证实物料是那些批记录中具体的用于指定中间体或原料药的物料。
- For supplements that do not require submission and review of an exhibit batch record and associated data, any commercial batch may be submitted. 对于不需要递交申请和不需要审阅批记录及相关资料的补充,可递交任一商业批次的样品。
- Routinely participate and responsible for APA production batch quality control. 参与并负责APA产品品控工作。
- We expect that all entries in logbooks, batch records, laboratory documentation and all other documentation be signed by the person who performed the operation. 我们期望的是日志、批记录、实验室文件以及所有其它文件中的所有录入都有操作人员的签名。