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GMP spot is checked and accept evaluate standards of grading
From;    Author:Stand originally

Check NO of category of of content standards of grading. Content person










Member 1. Factory director (manager) whether does record of formal schooling, title, experience accord with requirement record of formal schooling, title 30 minutes each; Experience 40 minutes 2. Whether does title of controller of production, quality, experience accord with a requirement 25 minutes each 3. Whether is controller of * production, quality permanent staff controller of production, quality is making up each 50 minutes 4. Whether is * quality controller full-time it is 100 minutes; Deny 0 minutes 5. Whether does record of formal schooling of qualitative check personnel, title accord with a requirement (100 minutes) make component by eligible scale 6. Whether does inspector pass the drug that save animal censorial place grooms the mount guard that hold card (100 minutes) make component by eligible scale 7. Whether does the change of quality controller pass the drug that save animal censorial place agrees is 100 minutes; Deny 0 minutes 8. Manufacturing staff record of formal schooling, groom whether to accord with a requirement (100 minutes) make component by eligible scale 9. Production assists personnel record of formal schooling to whether accord with a requirement (100 minutes) make component by eligible scale 10. Whether does the technical personnel such as labour of electrical engineering, fireman hold card mount guard via grooming (100 minutes) make component by eligible scale 11. Personnel of primary above technology occupies the scale of number of entire factory worker to whether accord with a requirement accord with 100 minutes; Do not accord with 0 minutes 12. Whether * worker undertakes GMP grooms regularly is 100 minutes; Deny 0 minutes 13. Whether is the worker familiar with animal drug regulation and laws and regulations of animal drug government (100 minutes) make minute of plant by eligible scale























Room 1. Whether is production installed in an appropriate environment, whether does field, air, water quality accord with requirement field 40 cent, air 30 cent, water quality 30 minutes 2. Whether does * plant area differentiate by administration, life, production, auxiliary area, whether is producing a division an independent district it is 100 minutes; Deny 0 minutes 3. The road surface inside manufacturing division whether level off, clean, do not have dirt level, do not remove dirt 30 minutes, clean 40 minutes 4. Whether are the ground that show native, seeper and midge fly had all round manufacturing division whether is grow virgin soil had pile up rubbish and litter do not have dew earth 20 minutes; Do not have seeper 20 minutes; The fly that do not have midge causes the ground 20 minutes; Do not have rubbish 20 minutes 5. Whether does * workshop press manufacturing technological process equitable distribution, stream of people, content shedding is reasonable distribution is equitable 50 minutes; Person, content shedding is reasonable 50 minutes 6. Whether does workshop have prevent the insect, avian, rat kind the establishment that waits for an animal to enter prevents the insect 40 minutes; Prevent avian 30 minutes; Prevent rat kind 30 minutes 7. Of * manufacturer room inside the surface, whether does the wall of clean workshop accord with the surface inside the requirement 40 minutes; Wall 60 minutes 8. * produces the space inside workshop to whether ask to suit with production is 100 minutes; Deny 0 minutes 9. Whether * workshop asks by different technology and quality requirement differentiates be different clean level is 100 minutes; Deny 0 minutes 10. Whether does the installation of equipment of cop of the duct path inside * clean workshop and water and electricity, craft, lighting accord with a regulation to carry conduit 20 minutes; Conduit 20 minutes; Electrical wiring 20 minutes; Lighting equipment 20 minutes 11. The area of keep in storage that whether intermediate body, semi-manufactured goods has inside workshop, keep in storage suits with production, whether the establishment that prevents alternate pollution has area of keep in storage 40 minutes; Store appearance suits 30 minutes; Prevent contaminative establishment 30 minutes 12. The facility that whether independence has inside workshop, tool cleans division facility, tool to clean a region 50 minutes each 13. The bathhouse that whether accord with installs to add up to production to ask inside workshop is 100 minutes; Deny 0 minutes 14. Whether is establishment of fire prevention of fire prevention, explosion proof establishment set inside workshop establishment of 50 cent, explosion proof 50 minutes 15. Whether the intensity of illumination inside workshop accords with a requirement is 100 minutes; Deny 0 minutes 16. Whether do the air grit number inside * clean workshop and vivid microbial number accord with a regulation, whether to check regularly unqualified for 0 minutes 17. Whether the workshop with clean different level is more than 4.9 handkerchief control the factory building with poor clean high level whether is the factory building with net to Xiang Linjie low level being pressed be more than 4.9 handkerchief to press difference 50 minutes is opposite pressing 50 minutes 18. Whether do personnel or stock pass the amortize establishment that photograph of as clean as its level gets used to, ability enters clean factory building is 100 minutes; Deny 0 minutes 19. Clean workshop is used besides the person, content is mixed with amortize establishment outside exit, whether setting the other channel outside leading to operation area is 0 minutes; Deny 100 minutes 20. The installation that pool, sewer washs his hands inside clean workshop area is appropriate, have the measure that avoids pollution installation is appropriate 50 minutes; Have measure 50 minutes 21. Building of * storehouse lay aside and establishment are to accord with a requirement to build 50 minutes, establishment 50 minutes 22. Whether will * wait for check, eligible, unqualified stock to departure piles up and have identify a mark to pile up apart 50 minutes apparently; Clear sign 50 minutes 23. Danger tastes the storehouse that whether has special segregation to save is 100 minutes; Deny 0 minutes 24. Whether does the enterprise build the control laboratory that suits with production, control laboratory such as room of observation taking shape to suit 50 minutes; Photograph of room of observation taking shape suits 50 minutes 25. Whether experimental animal room accords with a country to set is 100 minutes; Deny 0 minutes 26. * holds concurrently producing an enterprise to whether establish alone animal drug to produce a division is 100 minutes; Deny 0 minutes 27. Whether * animal drug has the measure that avoids alternate pollution between manufacturing division and other production is 100 minutes; Deny 0 minutes 28. * penicillin kind whether product production has independent manufacturing workshop is 100 minutes; Deny 0 minutes 29. * penicillin kind the product produces a workshop to whether have independent air conditioning system is 100 minutes; Deny 0 minutes 30. * penicillin kind whether when the product produces a workshop to produce other product, undertaking penicillin remains to the quantity is handled and determine is 100 minutes; Deny 0 minutes to set
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