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Examination of animal drug GMP is checked and accept master a principle
From;    Author:Stand originally
One, problem of layout, environment (one)Preparation layout To assure animal drug quality, according to principle of spirit of animal drug GMP and scientific, reasonable, applicable economy, animal drug preparation produces layout to answer first selection is different and different the form of a drug, clean the pattern that the product line that spends a requirement sets respectively. If transform or suffer limitation of plant area area to set product line respectively hard because of workshop, the beard is common of partial space, establishment, must master the following principle, but Lv of take an examination runs cost issue. Should consider the ceaseless promotion as animal drug industry and GMP level at the same time, right common means is existing to must be adjusted, adjustment problem. 1, final below the circumstance of the production when differring but fluid of bottled profess to convinced removes fluid of inject of sterilization small size and glass outside must be being installed alone between the facilities equipment that distributes outfit of conduit of fluid, infusion, fill and operation, other working procedure and person, content sheds a passageway but common an establishment and space, its production level is high not low. The administrative system that makes phasing close at the same time, clean, clean regulations, can assure to avoid to produce the generation of accident, pollution via test and verify, need to adopt effective assurance measure, result of test and verify and record bring into GMP key to check limits. 2, big infusion product line should be installed alone, do not get facilities of common and as same as other product space, facilities. 3, fluid of profess to convinced of compound of the Chinese and Western below the situation that produces when differ, Chinese traditional medicine fluid of profess to convinced and fluid of Western medicine profess to convinced but common a product line, the administrative system that makes phasing close at the same time, clean, clean regulations, can assure to avoid to produce the generation of accident, pollution via test and verify, need to adopt effective assurance measure, result of test and verify and record bring into GMP key to check limits. 4, for making up fluid of inject fluid, profess to convinced to use Chinese traditional medicine liquid extract, Chinese traditional medicine condenses fluid receive makings mouth to should reach 300 thousand clean level. 5, the Chinese traditional medicine below the situation that produces when differ injects fluid of fluid, Western medicine inject but common a product line, but the Chinese traditional medicine that special odour and colour and lustre are cleaned hard tastes kind of except. The administrative system that makes phasing close at the same time, clean, clean regulations, can assure to avoid to produce the generation of accident, pollution via test and verify, need to adopt effective assurance measure, result of test and verify and record bring into GMP key to check limits. 6, different raw material is used to manufacture dose of capsule of agent of Western medicine tablet, grain, grain below the situation that produces when differ, except shape, between inner packing outside, other process is usable and same a manufacturing facilities and space. The administrative system that makes phasing close at the same time, clean, clean regulations, can assure to avoid to produce the generation of accident, pollution via test and verify, need to adopt effective assurance measure, result of test and verify and record bring into GMP key to check limits. 7, below the situation that produces when differ, western medicine powder, mix agent and Chinese traditional medicine beforehand powder (except Chinese traditional medicine powder smashs an alone setting outside) usable and same a manufacturing facilities and space. The administrative system that makes phasing close at the same time, clean, clean regulations, can assure to avoid to produce the generation of accident, pollution via test and verify, need to adopt effective assurance measure, result of test and verify and record bring into GMP key to check limits. 8, below the situation that produces when differ, western medicine powder, outside mixing agent of agent, tablet, grain to divide the beard between the facilities facilities operation that controls process of bead, sheeting to be installed alone beforehand, passageway of other working procedure and person, content shedding is usable and same a manufacturing facilities and space, clean level is high not low. The administrative system that makes phasing close at the same time, clean, clean regulations, can assure to avoid to produce the generation of accident, pollution via test and verify, need to adopt effective assurance measure, result of test and verify and record bring into GMP key to check limits. 9, below the situation that produces when differ, chinese traditional medicine powder and Chinese traditional medicine pill shapes except pill outside, usable and same a manufacturing facilities and space, clean level is high not low. The administrative system that should make phasing close at the same time, clean, clean regulations, experience card can assure to avoid the generation of accident, pollution, adopt effective assurance measure, result of test and verify and record bring into GMP key to check limits. 10, penicillin kind the manufacturing environment of drug of animal of Gao Zhimin sex must be accorded with " GMP standard " requirement, all production process must not have the appearance that common, across, transmission equipment is interlinked with other product. Should achieve air current, content shedding, stream of people namely 3 " independent " requirement. 11, fall in the principle that does not cause mutual effect, enter plant area and plant area wife, content to sort separate issue, can not do mandatory requirement, but should make corresponding management system. 12, when the production when if inject fluid breed uses water and injection with inject,using oil to be menstruum to differ below same environment, outside providing path and fill outfit opportunity except canister mixing juice, infusion, other process is usable and same a manufacturing facilities and space. 13, high living things is active (like sex hormone kind) the product line that should set independence and independent air purify a system, discharge wind to should be put via handling back row. . 14, inject uses β - inside the manufacturing area that the production of acyl amine product should set opposite independence, can install with penicillin cent common product line; Blame inject uses β - inside of acyl amine product but as common as the other product that is the same as the form of a drug product line, but should undertake clean test and verify. 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