Comparison Of The Good Laboratory Practice Regulations In China,OECD And USA With The Conduct Of Quality Assurance

In the phase of pre-clinical drug research and development,No matter in China,OECD or USA,most of the toxicology studies tended to IND filling should be conducted under Good Laboratory Practice,however,the requriment differs a little from each other.This article begins with the history of GLP regulation in China,OECD and USA(especially for FDA),and indicates the current status and situation in above countries.The newest idea of OECD and FDA is presented and the difference of each other is listed.Also,the trend of this regulation and MAD system will be discussed,especillay for those Chinese pharmaceutical companies who want to market in USA and OECD member contries.Additionally,with the experience in this field,an outstanding example is present to show how to conduct the quality assurance work and the actual role of quality management under these regulations.