制药企业新项目实施中计量校准探讨

Research on the metrological calibration in the implementation of the new project of pharmaceutical enterprises

目的:为确保制药企业的计量校准工作符合"药品生产质量管理规范"要求,针对制药企业新项目实施过程中的计量校准工作中的重点问题进行探讨。方法:从计量校准工作过程中分解出计量信息收集、完善计量信息、测量设备的操作范围与最大允许误差确定、校准间隔的确定、测量设备的分类管理以及内控校准规程制定6个关键问题进行分析,并给出实用的解决方法。结果:确保了企业计量校准过程可控、结果准确可靠及数据可追溯。结论:制药企业新项目实施时,计量校准工作关键问题需利用好这些解决方法,可为日后的计量校准工作打下良好的基础,保证计量校准工作符合"药品生产质量管理规范"要求。

Objective： To ensure that the metrology calibration in pharmaceutical enterprises is in compliance with the requirements of GMP, the key issues in the metrology calibration that is in the process of the implementation of the new project of pharmaceutical enterprises are researched on. Methods： The six key issues in the metrology calibration process are identified and are researched on. The six key issues is collection of the metrology information, completion of metrology information, determination of operating range and maximum permissible error, determination of calibration interval, classification.m.anagement of measuring equipment, formulation of internal calibration procedure, and practical methods for the above issues are presented. Results： the metrology calibration process is controllable, the measurement result is accurate and reliable, and the measurement data can be traced back. Conclusion： when the implementation of pharmaceutical enterprises new projects, that the key issues of the metrology calibration process are made good use of these solutions can lay a good foundation for future work, and ensure that the metrology calibration process is in compliance with the requirements of GMP