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Examination of animal drug GMP checks and accept criterion for evaluation (chang

来源: 作者:Stand originally 时间:2008-12-28 Tag: 点击:
One, Examination of animal drug GMP checks and accept assess regulation 1, basis " management of quality of animal drug production is normative " (GMP of drug of animal of the following abbreviation) reach its appendix, make examination of animal drug GMP check and accept criterion for evaluation. 2, examination of animal drug GMP checks and accept a project in all 220, among them crucial project (add before term No. " * " ) 47, average project 173. State of examination distribution of item (crucial / check) : Orgnaization and personnel 3/15; Workshop and establishment 10/55; Equipment 5/22; Stock 8/23; Wholesome 0/19; 3/10 of test and verify; File 1/11; Production manages 12/35; Quality manages 5/17; Product sale and call in 0/5; Complain with 0/3 of harmful response report; Self check 0/3. 3, when organizing animal drug GMP to check and accept an examination, must check limits in order to apply for, according to animal drug GMP the examination checks and accept a project, determine corresponding examination limits and content, add before the clause among them " # " the article that assess does not have when be being checked for the static state. 4, when the spot is checked, answer place to list a project to reach its to cover content to have comprehensive examination, and item-by-item makes assess. Assess result cent is " N " , " Y ˉ " and " Y " 3 archives, every belongs to complete, all ready project, should decide for " Y " ; Every belongs to project content basic and complete, all ready, but the project that still perfects not quite, should decide for " Y ˉ " ; Decide some accord with a requirement basically (if hit cent to should be in 75 minutes above) , hit " Y " ; Decide some is put in certain blemish (if hit cent to should be between 75-50 cent) , hit " Y ˉ " ; Decide some flaw is serious (if hit cent to should be in 50 minutes the following) , hit " N " . When collect according to 3 " Y ˉ " be equivalent to 1 " N " mix 2 " Y " principle check and ratify. Through percentage consideration comes whether does assess accord with GMP. Crucial project is unqualified call serious flaw; Average project is unqualified call common flaw. Quality of drug of serious effect animal inspects the other problem that discovers in common flaw project or examination to be serious flaw together, procuratorial work member should investigate to this obtain evidence, detailed notes. 5, be not clean area to produce environmental requirement and sanitation to wait consult clean area runs a level. 6, static examination checks and accept the basis that should completing main production facilities, sterilization facilities, craft to confirm the work such as experiment test and verify and product craft test and verify with the function such as water facilities aspirant travel. 7, as a result assess

Project result is serious common flaw adopts limitation examination of animal drug GMP is checked and accept, should make " recommend " conclusion changes medical Chinese traditional medicine 25% 0 23 of ≦ of 0 ≦ 22% , 43% 26, the examination is tracked after 6 months rectify and reform 46% deadline, should make " defer recommend " 25% of ﹥ of 22% of ﹥ of 3 of ≦ of 25% of ≦ of 22% of ≦ of conclusion ≦ 3 has been illogical examination of animal drug GMP is checked and accept, should make " do not recommend " conclusion ﹥ 3

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