gmp是什么意思？药品生产质量管理规范常识( 六 ) _gmp

42、分批的原理是什么？
答案：在规定限度内具有相同性质和质量的一批药品，在相同的连续生产周期内生产。
(1) 在成型或分装前，使用同一混合设备将非无菌药品中的固体和半固体制剂一次性混合生产的一批均质产品。如果采用分级混合，已验证在规定限度内生产的一定数量的均质产品是一个批次；
液体制剂：由最终混合药液在灌装（封口）前制成的一批均质产品。
（2）大、小容器无菌药品的注射剂，以同一剂量罐中一次配制的液体制成的一批均质产品视为一个批次。粉针剂是由同一批原料药在同一连续生产周期中生产的一批均质产品。-driedis a batch ofin the samecycle.
3 Theof batchof APIs areinto two cases: ①APIs andatimeare a batch. ② For APIs, a batch ofthecan beby finalof aof .
43、What are theof?
: Theofcan beinto: net , , , ,( ), , etc. Theisoutto the, and theis based on theand Henanfor.
44、What is theof?
: Theofis toortheor sideof the drug,orthe drug ;the;ortheand trend of the drug ;to use.
45、Into theof36, whatbein the batch?
: Italso :, a copy of the siteof the last ,( batch , ),and,,byor( ,), theplantis , ,and other on-site ,and site,,,,audit form, etc.
46、Does batchof raw andand?
: In the batch, for the raw ,, andused, it istothe.to the, theof thecan be . , theNotin batch.
47、WhatI do if thethe limit in ?
: When thethelimit, a -upmust beout from theto the . Only when thecan prove that there is no error, thecan beto the next step. One-steporof theas . At the same time,andthe , andthelimit if .
48、What are theforwater?
: ⑴ watermeet theofwater -85. (Need to beby the)
(2)waterwith.
3 Water forwith.
49、What are some of theforwater,water, and water for ?
: ⑴ waterbeforon a daily basis.
(2) Dailyof PH value, ,salts, heavyandofwater.
3 Into the above five items, the dailyof water foralso checkandonce a day.
50、WhatI payto whenwater for ?
: The tank vent of the water formust bewith athat does not shed . Theof water forcan be kept at aabove 80°C,at aabove 65°C, orat abelow 4°C.
(五）
51、What are thefor the?
: ⑴Theof thearea is clean and tidy, free of weeds andwater, and noforand flies, and the airmeets theby the state;
(2) Thearea,area andarea are , and the flow ofandis ;
3 There is no waste andin thearea. Thethearea must be far away from thearea, withand, andand , so as not totheof thearea;
⑷Thein theareabe clean, , free ofand , andandbyin time;
⑸and other items in thearea must bein thearea and shall not bein other .
52、What are theforareas?
: (1) Doors, , glass, walls, andbe clean, free of dust, and thebe flat, free ofwater and . Theandare clean and , theandareand ,, ,or , and there areofand ;
2) Thetools,andbeandto the ;
⑶Raw ,andareandat, with dust-proofandmarks;
⑷ ,andstore items, keep themand clean;
⑸Thesite isbut. Do not smoke, eat, sleep, meet , or dry thein thesite.

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53、What are theforareas?
: (1) The outerof thebe , free from , , moth-eaten, rat bites, etc.theroom, take off the outerand stack it in the. After the , seal theandand;
2 。The rawofbe pre-to the , and then put into a cleanandto the next . The rawofused inmixedbeto the one-time, andin theof eachareato the neat code of the , and the rawcan be fed only after the pre- andare ;
3 Eacharea of ??the pre-can onlyone type of, and the site must bewhen. Eacharea of ??thecan only store all the rawoffor one, and the site must bewhen theistocross- and .
⑷Thenot beon the , butbe dried in, and are notto beto the sun;
⑸Each, , and post shallandto theofand, andabide by them;
⑹Keep theclean and free ofandit totheorused from,and ;