Research on the metrological calibration in the implementation of the new project of pharmaceutical enterprises
10.3969/J.ISSN.1672-8270.2016.04.038
- VernacularTitle:制药企业新项目实施中计量校准探讨
- Author:
Wei LIU
- Publication Type:Journal Article
- Keywords:
Metrological calibration;
Good manufacturing practice;
Maximum permissible error;
Calibration interval;
Internal calibration procedure
- From:
China Medical Equipment
2016;13(4):120-122,123
- CountryChina
- Language:Chinese
-
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.
