Gap Study On Sterile APIs GMP Management Among China, US And EU

Chinese pharmacy industry GMP has already put into effect for about 15 years, but the US and Europe experts think that the gap of Chinese manufacturer GMP management is away from strict US and Europe GMP, the number of Chinese API manufacturers being able to export to US and Europe marketplace only accounts for about 30% of the sum, and only several sterile API manufactures have passed the EU EDQM audit, but there is still no domestic sterile APIs manufactures passing USA FDA audit so far. This research has mainly studied FDA Six-system Audit Model, found the law and regulation difference between FDA , European Union and Chinese CGMP regulations, have surveyed the current situation of GMP management in most Chinese Sterile APIs manufactures, as a result of this research, the difficulty for Domestic sterile APIs manufactures entering the US and EU market depends on the overall design of the aseptic process handicraft flat, depends on the high standard software demand of producing , depends on the completeness and scientific nature of the validation, depends on the aseptic operation consciousness of the personnel. Chinese APIs manufactures must draw the scientific management thoughts of US , Europe and WHO, studies international regulations, joins PIC/S, reduces the Microorganism,particle,Bacterial Endotoxin contamination by improving technology level, carries out the new technique,training the employee's sterility consciousness to guarantee the product quality, carries out the whole process quality control, all procedures must be strictly in progress according to the validated method and procedure , product release not only according to the test results , may also consult the parameter principle to release. China, as the biggest APIs manufactures in the world at present, is surely having the capability completely to break the US and Europe marketplace audit barrier, if the sterile APIs made in China will walk more distant and much higher, the manufactures must put in time and energy on quality level and the audit documents, really standard the aseptic production and quality management.