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Noun of GMP of Chinese animal drug explains
From;    Author:Stand originally

Preparation of asepsis of 1 of number name explanation is nonexistent vivid biologic preparation product. The biomass that 2 is not asepsis preparation place to contain work accords with the preparation product that wholesome standard provides. 3 reference point is in controlled condition to assure working procedure, below proper time and certain condition, character of key pilot quality, crucial position or weak point require in product production process. 4 approves the quality that has same quality inside formulary limit, produce manufacturing a certain quantity of drug in same production cycle. 5 lot number is used at identifying " to approve a group of numbers of " or alphabetical addend word. Those who use is OK date from and the manufacturing history that investigate this batches of medicines and chemical reagents. What the product that 6 approves manufacturing notes to record a lot number uses Yuan Fucai makings and the document that undertake operating in production process, include to make detail of the pilot in the process. All written standards that involve drug production, government mix 7 file the record result in carrying out. 8 waits for check department to show stock is in allow to cast before expect or leaving factory, lay aside locatedly, wait to examine the result, position that cannot use. The vivid biology with 9 completely nonexistent asepsis [note: Asepsis condition is absolutely, the sterilization of asepsis condition 10 of nonexistent different level makes achieve quality of aseptic condition 11 to product, process or service satisfy a regulation or ask potentially (or need) the quality that quality of feature and diagnostic summation 12 assures to to make people believes firmly some product, process or service quality can satisfy a regulation asks. The work skill that the quality that 13 quality control satisfies a regulation to maintain some product, process or service quality asks to adopt and activity. The management of the function that 14 quality management asks to need to decide and reaching mass and activity. 15 quality system satisfies a regulation to assure product, process or service quality or potential demand, wait for the organic whole that form by origanization construction, duty, program, activity, ability and resource. 16 quality is supervised ask to assure to satisfy quality, by user or tripartite is right Wu of kimono of condition of program, method, product, process has successive opinion, ask to undertake an analysis to the record by formulary level or contract. Technology of the workshop installation that in proof of in order to of 17 test and verify is produced in medicines and chemical reagents and examining, uses and equipment, Yuan Fucai makings, production, quality controls a method to wait to whether achieve those who expect an end really a series of activities. 18 condition mark is used at demonstrate the mark of the condition of Yuan Fucai makings, product, container or machine. 19 is purified point to to get necessary clean spend and the process of purify pollutant. 20 air purifies the pollutant in purify air, the behavior that makes air clean. 21 pollutes the object that regards processing as the object or material, as a result of conglutinate, interfuse or generation some is planted material, its function and the course that function produces undesirable effect or make its undesirable the condition of the influence, call contaminative 22 contaminant to regard processing as the object of the object or material, as a result of conglutinate, interfuse or generation some is planted material, make its suffer pollution, this kinds of material calls contaminant. 23 is clean the condition that was not polluted is called clean. Basis of 24 clean room needs, to the grit in air (include microbial) , temperature, pressure and noise have pilot airtight space and with its air is clean spend grade to accord with medicines and chemical reagents to produce quality management standard to be main feature. 25 is clean the air in spending headroom pointing to clean to enrage contains dirt (include microbial) the rate that how much estimates. The area that 26 clean area forms by clean room. Float of horizontally pivoted hung of air of condition of ring of 27 asepsis room is microbial the quantity asks to manage by asepsis, contented asepsis produces the clean room of the requirement. 28 personnel is purified what undertake depurative by due process before entering clean room with room staff is auxiliary with room. 29 stock is purified what undertake depurative by due process before entering clean room with room stock is auxiliary with room. 30 gas lock chamber is the air that keeps clean and indoor clean the amortize room that spend and pressing control and sets. 31 air is blown drench the room is compulsive blow except the establishment of adherent grit on staff member and its dress. The building line both sides of the street that uses what 32 technology interlining basically forms with horizontal thing space for installing the establishment such as cop. Organization of 33 air current shows to air current flow direction and uniformity press particular demand to have an organization. 34 is one-way stream have parallel, with onefold access single way carries the air current of clean room or clean area. (ever called " laminar flow " ) . 35 blame is one-way flow have many access or air current direction is not parallel, not contented and one-way the air current that sheds a definition. (ever said " chaos sheds " ) . Department of 36 pure water goes of ionic water and distilled water appellative. 37 distilled water must accord with distilled water of Chinese animal pharmacopoeia through distillation legal system the water of next regulations. 38 goes rate of the resistor when ionic water points to the 25 ° C that gets via ion exchange legal system is more than 0.5 × the water 39 inject of 106 Ω .cm accords with inject of Chinese animal pharmacopoeia to use water with water the water of next regulations. Test of 40 empty state shows clean room purifies air conditioning system to already was in normal moving condition, indoor the test that did not have below technological equipment and the situation that produce personnel. Test of 41 static state shows clean room purifies air conditioning system to already was in normal moving condition, technological equipment already was installed, indoor the test that did not have below manufacturing staff circumstance. 42 trends test shows clean room already was in the test that has below normal production condition.
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