The Study Of Quantification Management About Xiuzheng Drugs Manufacture Group

The domestic drugs production enterprise's GMP authentication deadline arrival proposed which along with the national food drugs surveillance administrative bureau, the Chinese drugs manufacture enterprise already was producing the hardware, the software and the staff quality and so on several aspects obtained the considerable enhancement, already initially had at least in the pure working condition aspect with the international drugs manufacture enterprise dialogue possibility. But, said regarding the pure drugs manufacture enterprise that, as a result of aspect the and so on own condition limit, after the GMP authentication very long section of times, is comes from the GMP standard limit which the enterprise felt, but is not the instruction and the help.The drugs manufacture profession is facing from the traditional process to the modern technology reforming process; The medicine domain is facing the comprehensive reform impact, the new industrial pattern is forming. The medicine profession output value speed-up is higher than other profession average levels by far. The profession rapidly development urgent need promotion whole management level, is also more intense to the standardized technology application and the management innovation request.Is precisely in under this profession environment influence, revision has formed the GMP quantification management conception gradually.First, establishes the GMP quantification management system, constructs suits in the quantification management organizations and agencies.Next, has formulated the medium and long-term plan. The revision GMP quantification management implementation divides three steps:...