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" attestation of GMP of medicines and chemical reagents checks criterion for eva

来源: 作者:Stand originally 时间:2008-12-29 Tag: 点击:
" attestation of GMP of medicines and chemical reagents checks criterion for evaluation (try out) " apply at was being released in November 1999, the GMP attestation that produces a business for normative medicines and chemical reagents produced main effect. But the need that tentative standard already cannot get used to current drug production completely to superintend, liability of the heavy in GMP attestation hardware that be in, light software is put in tentative standard especially, must try to improve.

The standard that produces for farther strict medicines and chemical reagents asks, consolidate rectify and order of normative drug market is special the achievement of the action, superintendency bureau of national provision medicines and chemical reagents edits promulgated " attestation of GMP of medicines and chemical reagents checks criterion for evaluation " , already began to apply at rising on January 1, 2008.

As we have learned, new " standard " repair instead by 225 original 259, among them crucial project is adjusted by 56 it is 92, average project is adjusted by 169 it is 167, basically increased to be in to the enterprise the skill that the software such as file of control of process of personnel aptitude, production, quality, test and verify runs a side asks, in order to ensure medical character is measured.

New " standard " attestation examination criterion for evaluation is more strict. For example, according to tentative standard, if the serious flaw of attestation examination discovery is little at after deadline is rectified and reform, 3 can pass attestation. But new " standard " regulation, serious flaw exists without discovery when the enterprise is accepting attestation to check, and run-of-mill blemish is little 20% at inspecting an item, ability passes GMP attestation. If have,serious flaw will not pass attestation.

Be in to check medicines and chemical reagents produces a business effectively the practise fraud behavior in GMP attestation, new " standard " regulation: "In check out procedure, discover what the enterprise conceals concerned condition or provide false data, press serious flaw processing. Inspection team should be investigated obtain evidence, detailed notes. Detailed notes..

New " standard " emphasize an enterprise carrying out GMP to must register file photograph to match with medicines and chemical reagents, medicine of enterprise producer goods or preparation must organize production according to the manufacturing technology that registers approval and prescription. New standard still strengthened the supervisory examination to business software, mix strictly refined control of pair of company staff configuration, quality, stock to purchase, the examination project of the respect software such as file management, this makes those take workshop, equipment seriously to wait to hardware is built and ignore software construction only, especially the enterprise that management of quality of medicines and chemical reagents does not reach the designated position hard pass a barrier. Dcl
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