Comply with the calibration management of international GMP for pharmaceutical production
In the process of drug production,in order to ensure the quality of products,the control pa-rameters of each process(especially for the critical process parameters)are particularly important.The process validation of the product and the performance qualification of the equipment are carried out around the control parameters of the product.Therefore,the management of measuring instruments relat-ed to drug production is an important part of drug production.This paper discusses the implementation method of calibration management in line with international GMP requirements by comparing the require-ments of GMP on calibration management,instrument classification,acceptance criteria and lifecycle setting,so as to provide reference for the calibration management of pharmaceutical manufacturers.