gmp是什么意思？药品生产质量管理规范常识( 七 ) _gmp

⑺clean the fans, flues and air ducts in theto keep them free ofdust and dirt.
54、What are thefor?
: (1)acheck every year, andfiles. After the check, all thosefrom,,, and skinwill befrom their posts and nottoin drug ;
p>
2stafftakebaths, cut hair, shave, trim nails,, and;
3going to work every day, youwear clean,work , work shoes, and work caps in theroom that meet the workofareas;
⑷ Wash handswork, andstaff are notto wearor apply ;
⑸ Whenthe , you must take off your work , work shoes, and work caps.
55、What are thefor workin thearea?
: (1) Work( work shoes and work caps)have a smallof dust, not lose , not easy to, not easy toto , no ,and soft after , andandto wear;
(2) Thein the clean area and thearea are, easy to , andnot be mixed;
3 Cleanto the work. Workfor dust,, toxic andbe,and .

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56、What are thefor theoffor plant,and ?
: , , , etc.beto theof drug, , postand air. The:, ,time,used or ,andfortools.
57、WhatI look for whena ?
:must not,and. The floor draincan befromandsoap , and the twobetotheof drug- .
(六）
58、What does the drug?
: Drugair,of main raw and,water ,and its ,and,andfordrugs,ofand(sub-) , etc.
59、What is theof thefile?
: The:,,and.
60、What isin theof?
: (1) ; (2); (3); (4). Afterthe above, theGMPwill issue afor use.
61、What are theof the airplan?
: ⑴ ; ⑵; ⑶grade; ⑷of; ⑸ dust;
62、What is ?
:to a , a , a piece ofor athat isfor use afterthe , and re- after a stage of use. Itsis tothat thestate has not . For,is often .
(七）
63、What is the eight-for safe ?
:first,first.
64、What are the "five " of?
: fixed-point, , , , fixed.
65、What are the fourfor?
: neat, clean, , safe.
66、What are the "five " of?
: ⑴Use thewith theandthe;
2 Keep theclean andas ;
⑶ with the shift ;
⑷Take good care of tooland do not lose them;
⑸ If anyis found, thebe shut down . If itbeby , thebein time.
67、What do the "three good" and "four " ofwork refer to?
: "Three good"to:it well, use it well, andit well.
"Four " means: use, , , and.
68、What is theof the trap?安装疏水阀为什么要装旁通阀？什么时候用它？
答：其作用是阻汽排水。安装旁通阀是因为对那些间歇加热设备，为了提高其热效率，开始使用时应快速排出系统内积存的凝结水和不凝性汽体，以提高用热设备的热效率。只有当设备开始时开启，当观察有稳定蒸汽排出后，即关闭旁通阀，疏水阀自动投入工作。
69、影响企业的能源利用率的因素是哪些？
答：主要有：⑴设备的性能及其工作效率高低；
⑵设备能源转换效率的高低；
⑶管理因素；是否存在跑、冒、滴、漏现象。
70、制药设备应符合什么要求？
答：制药用设备与药品直接接触的表面应光洁、平整、易清洗或消毒、耐腐蚀，不与药品发生化学变化或吸附药品。设备所用的润滑剂、冷却剂等不得对药品或容器造成污染。
71、制药设备所用不锈钢的材质有哪些？
答：⑴普通不锈钢，由铬、镍、钛组成（）含碳量稍高；
⑵304L不锈钢，由铬、镍、钛组成（）含碳量次之；
⑶316L不锈钢，由铬、镍、钛、钼组成（）含碳量较低。
72、为什么说计量工作是企业的一项重要工作？
答：因为它涉及企业经营管理、工艺控制、检测、安全防护、环境监测、贸易结算等环节，没有准确的计量，就没有可靠的数据，企业的决策工作就没有依据，因此说计量工作不光对企业的质量体系的建立与运行，甚至对企业的全部工作都起重要的支持和保证作用。按GMP要求，企业所有计量设备（衡器、天秤、压力表、流量表、温度表）均需由技术监督局进行校验，并在设备上加贴合格证，才能投入使用。而精密仪器（薄层扫描仪、高效液相色谱仪&;…等）需经省技术监督局校验合格，才能使用。