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Animal drug produces quality to manage normative examination to check and accept
From;    Author:Stand originally
The first chapter Total Criterion The first To drive " management of quality of animal drug production is normative " (GMP of drug of animal of the following abbreviation) carry out, examination of GMP of normative animal drug checks and accept the job, make this way. The 2nd The Ministry of Agriculture is in charge of management of GMP of countrywide animal drug and examination checking and accept the job; Be in charge of making edit examination of animal drug GMP checks and accept management to set; Team of censor of GMP of responsible animal drug is built and control administrative job, each other of the GMP in trade of drug of responsible international animal knows the work. The 3rd Department of administration of vet of pasturage of provincial people government is in charge of this administration examination of GMP of drug of animal of the application inside area is acceptable the first trial that produces a business works, be in charge of GMP of drug of the animal inside area of politics of one's own profession grooming, business guidance, day-to-day supervisory management and dog the examination works. The 2nd chapter Declare with examine The 4thBuild, rebuild, extend and the company of animal drug production that undertake GMP is transformed and build, rebuild, the animal drug that extend and GMP transform animal drug to produce a workshop produces a business, ought to put forward examination of animal drug GMP to check and accept application by the regulation. Build animal to produce a business with biological product must preparing to construct forward the Ministry of Agriculture is referred prepare to construct application report, after classics approval, GMP of the medicine that press animal asks to design and be built. The 5thCheck of GMP of application animal drug checks the company that control to ought to fill in by the regulation " animal drug GMP checks application form " (see an appendix 1) , send by newspaper of the following requirement written reach electronic documentation triplet of each one type: Send by newspaper of the following requirement written reach electronic documentation triplet of each one type:: OneOneBuild enterprise and the business that add product the form of a drug newly Report of 1. project approving, project approves file and company general situation; 2. Plan to produce animal drug category, the form of a drug and catalogue item; 3. Company origanization construction pursues (must make clear departmental door name, controller, function and correlation) ; 4. Resume of company controller, branch chief; Professional technology personnel and production, examine, the staff member registration form such as storage (include literacy rate, record of formal schooling, title to wait) , indicate place branch and post; The scale circumstance list that personnel of tall, medium, primary technology takes faculty; 5. Enterprise periphery environment pursues; Total plane arranges a plan; Storage plane arranges a plan; Plane of quality inspection place decorates graph and instrument equipment to arrange a plan; 6. Manufacturing workshop general situation and craft distribution plan (include bathhouse, wash one's hands and face, stream of people and content are current talk, angry brake, flow direction of stream of people, content shedding and air are clean spend level) ; Air purifies a system send wind, answer plane of wind, platoon wind to arrange a plan; Technological equipment plane arranges a plan; 7. Reference point of the technological process plan that plans to produce animal drug product, main process and control project and product production, quality manages a file; 8. The crucial working procedure of production, main facility, system that make water and air purify circumstance of test and verify; Examine with circumstance of desired result of instrument appearance, measure, weighing apparatus; 9. The clean room that the Ministry of Agriculture approbates a lab to issue detects transaction (transaction period of validity 6 months) ; 10. Animal drug GMP runs file and specimen page of all sorts of records, proof; 11. Manufacturing facilities facilities, check meter implement equipment list (make clear parameter of norms, model, main technique) .
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