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New edition " attestation of GMP of medicines and chemical reagents checks crite
From;    Author:Stand originally

To vise general manager of limited company of the pharmacy on Changshu thunder allow Chen Li is built for, 2008 is a not average age. In this year, changshu should finish whole to remove on thunder allow. And as a result of new castigatory " attestation of GMP of medicines and chemical reagents checks criterion for evaluation " (the following abbreviation " new " standard " " ) began to carry out on January 1, 2008, this means new workshop to want according to new examination standard, pass GMP attestation inspection afresh, ability start working produces drug.

In fact, need to be checked through GMP attestation afresh, one goes up in allow of thunder of domestic more than Changshu. Well-known, arriving 2003 between 2004 is the fastigium that our country medicines and chemical reagents produces an enterprise to pass GMP attestation, according to the country relevant code, every already passed GMP acceptable the form of a drug, project, must undertake 5 years completely again attestation. The message says, according to not complete count, today bright need two years to press new " standard " undertake again the drug production company of attestation will amount to many 2000.

   New standard raises a threshold

The data shows, " attestation of GMP of medicines and chemical reagents checks criterion for evaluation (try out) " carry out at was being promulgated in November 1999. Chief expresses related supervisory management board of national provision medicines and chemical reagents, as rectify the ceaseless development that works with order of normative drug market, the development that supervises work of GMP of executive medicines and chemical reagents is begun, former GMP attestation checks criterion for evaluation more and more show not perfect, unreasonable issue, existence GMP carries out the phenomenon of light software of earlier heavy hardware, "Incommensurate expire to already carrying the business of GMP attestation again the need of attestation " .

It is reported, new " standard " it is the provision of GMP of medicines and chemical reagents that the basis has implemented at present, decompose according to every project, content make, repair instead by 225 original 259, among them crucial project (add before term No. " * " ) adjust by 56 it is 92, average project criterion by decrease 169 times it is 167.

An authoritative personage points out: "New " standard " more strict. According to original standard, if attestation examination discovery is serious blemish is little at 3, can deadline is rectified and reform, undertake attestation next. But new " standard " regulation, if have,serious flaw will not pass attestation. New " standard " return a regulation, did not discover serious flaw, and common flaw ≤ of 20% , can correct instantly, the enterprise must be corrected instantly; Cannot correct instantly, the report that must provide blemish to rectify and reform and rectify and reform, classics the ability after rectifying and reform passes attestation of GMP of medicines and chemical reagents. This means an enterprise to want to obtain GMP letter, must come true ' 0 blemish ' . Must come true ' 0 blemish ' ..
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