中国医学装备2016，Vol.13Issue(4)：120-122,123,4.DOI:10.3969/J.ISSN.1672-8270.2016.04.038
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
刘炜1
作者信息
- 1. 北京天坛生物制品股份有限公司计量室 北京 100176
- 折叠
摘要
Abstract
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 management 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.关键词
计量校准/良好生产规范/最大允许误差/校准间隔/内控校准规程Key words
Metrological calibration/Good manufacturing practice/Maximum permissible error/Calibration interval/Internal calibration procedure分类
医药卫生引用本文复制引用
刘炜..制药企业新项目实施中计量校准探讨[J].中国医学装备,2016,13(4):120-122,123,4.
