产品批号管理 Product Batch Number Management

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产品批号管理是指对产品生产批次信息的系统化管理，以确保产品追溯性、安全性和质量控制。
有效的批号管理可以帮助企业追踪产品的生产过程、批次信息、质量检验情况，以及在出现质量问题时快速定位问题源头.



Product batch management refers to the systematic management of production batch information to ensure product traceability, safety, and quality control.Effective batch management can help companies track the production process, batch information, quality inspection status of products, and quickly locate the source of quality problems when they occur

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• 批号编码设计
  
  • 设计科学合理的批号编码规则，包含生产日期、生产线、批次序号等信息。
  • 确保批号唯一性，便于追溯。
    
• Batch number coding design
• Design scientifically reasonable batch number coding rules, including production date, production line, batch number and other information.
• Ensure the uniqueness of batch numbers for easy traceability.
  

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批次信息记录

• 在生产过程中实时记录批次信息，包括生产时间、生产设备、原材料批号、检验结果等。
• 使用ERP系统或专门的批号管理软件进行数据存储.
  

Batch information record
Real time recording of batch information during the production process, including production time, production equipment, raw material batch number, inspection results, etc.
Use ERP system or specialized batch management software for data storage

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批次追溯

• 建立完整的追溯体系，可以根据批号查询原材料来源、生产过程、检验检测、出货信息等。
• 追溯范围应涵盖原材料、生产、检验、包装、存储、销售等环节
  

Batch traceability
Establish a complete traceability system, which can query the source of raw materials, production process, inspection and testing, shipment information, etc. based on batch numbers.
The scope of traceability should cover links such as raw materials, production, inspection, packaging, storage, and sales.

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• 批次管理流程
  
  • 设定批次创建、变更、冻结、废弃等操作的流程和权限。
  • 定期对批次信息进行核对和更新。
    
• Batch management process
• Set the process and permissions for batch creation, change, freeze, discard, and other operations.
• Regularly verify and update batch information.
  

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• 质量控制
  
  • 根据批号信息进行质量分析，识别潜在风险。
  • 在出现质量问题时，快速定位相关批次，进行召回和处理。
    
• quality control
• Conduct quality analysis based on batch number information to identify potential risks.
• When quality issues arise, quickly locate the relevant batches for recall and handling.
  

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合规与审计

• 确保批号管理符合行业法规和标准（如GMP、ISO等）。
• 定期进行内部审计，保持批号管理的规范性和完整性
  

Compliance and Audit
Ensure that batch management complies with industry regulations and standards (such as GMP, ISO, etc.).
Regularly conduct internal audits to maintain the standardization and completeness of batch number management

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技术支持

• 采用条码、RFID等技术提高批号管理的效率和准确性。
• 利用信息化系统实现自动化管理和数据分析。
  

technical support
Using barcode, RFID and other technologies to improve the efficiency and accuracy of batch number management.
Utilize information technology systems to achieve automated management and data analysis.

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