• A numbered copy of the M-aster batch production record is produced for every batch which serves as an Operating Procedure.

    一批批生产记录根据操作程序生产记录副本进行填写。

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  • Review batch production record after production finished, assure production process conform to process procedure GMP requirements.

    生产结束审核生产记录确保生产过程符合工艺规程要求和GMP要求。

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  • Draft out production management document batch production record, modify process procedure GMP relative record, assure production work has regulation to follow.

    组织编写生产管理文件生产记录修订工艺规程及GMP相关记录,确保生产工作有法可依

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  • The batch production record should be checked before issuance to ensure that it is the correct version and a legible accurate reproduction of the appropriate master production instruction.

    记录发放之前应当检查版本是否正确,是否是相应生产工艺规程准确明了的再现

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  • Materials, which fail to meet the specification, are documented in an appropriate document (i. e. analytical report). The document is attached for the finished material to the batch production record.

    符合质量规格的原料一种适当文件(检验报告)进行存档。这份文件最终产品生产记录中。

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  • Prior to use, production personnel should verify that the materials are those specified in the batch record for the intended intermediate or API.

    使用生产人员应当确认物料要生产中间体原料药记录指定的。

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  • Prior to use, production personnel should verify that the materials are those specified in the batch record for the intended intermediate or API.

    使用生产人员应当确认物料要生产中间体原料药记录指定的。

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