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1、新版新版 gmp,gmp,培训心得体会培训心得体会,XX,XX,年年 6,6,月在月在 郑州郑州篇一：新版 GMP 基础知识培训材料.pdfGMP 基础知识培训材料306 车间-XX 年 一、我国实施 GMP 的发展阶段 二、 GMP药品生产质量管理规范三、GMP 各要素可归类为：人、机、料、 法、环 一、我国实施 GMP 的发展阶段我国自 1988 年第一次颁布药品 GMP 至今已有 20 多年，其间 经历 1992 年和 1998 年两次修订，截至 XX 年 6 月 30日，实 现了所有原料药和制剂均在符合药品 GMP 的条件下生产的 目标。而最新版药品 GMP，已经于 XX 年 3 月
2、1 日起施行， 新版药品 GMP 共 14 章、313 条，相对于 1998 年修订的药品 GMP，篇幅大量增加，被称为“史上最严GMP” ，现有药品 生产企业将给予不超过 5 年的过渡期。企业经历了普及推广、强制实施、全面提高三个阶段。从 XX 年 1 月 1 日起所有药品（包括中药饮片、医用氧）都在 符合 GMP 条件下生产。 质量管理理念经历了“检验控制质量” 、 “生产控制质量 ” 、 “设计控制质量”三个阶段。 现颁布的药品生产质量管理规范 （XX 年版） ，从格式到内容基本与国际标准接轨二、GMP药品生产质量管理规范这是一项管理标准，技术法规，是药品生产企业必须遵循 的基本原则1、
3、实施 GMP 的目的 实施 GMP 的目的是防污染、防混淆、防人为差错 把影响药品质量的人为差错减少到最低程度 防止一切对药品污染现象的发生以保证药品质量因此必须建立健全完善的生产质量管理体系 所有法律、法规、规则和指导大纲都是为了一个目标：控制 -要控制你的生产工艺 -要控制你的供应商-要控制你的质量篇二：6、XX 年郑州市外国语中学潜能测试题XX 年郑州市外国语中学潜能测试题 （满分 50 分）一、根据句意及首字母完成单词。 （5%）to watch movies.4. In some counties, it.jokes.二、单项选择。 （10%）(A a; a B /; the C t
4、he; / D the; the() 2 I want something to drink, but there is water.A few B a few C little D a little() 3 Jim, would you please a message TomA give; to B takes; toC give; for D take; for() 4 This kind of shirt looks and sells .A good; well B well; well C good; good D well; good() 5 Mary often does so
5、me washing Sunday morning.A atB in C on D by() 6 The man asked the policeman .A let him to goB to let him to go C let him go D to let him go() 7 The woman was tired that she couldnt walk on.A so B too C veryD quite() 8 Ill go with you if I free tomorrow.A will beB shall beC amD was() 9 -I like the p
6、arty so much, but I go home. Its too late.-What a pity!A mustB mayC have toD can() 10 Pleasant Goat and Big Wolf is one of in the world.A more popular song B the most popular cartoonsC the most popular cartoon D more popular plays三、根据答语写出相应的问题。 （10%）s sunny today. Its wonderful!四、阅读理解。 （10%）阅读下面两篇短文
7、并按短文后的要求答题。AOnce there was no zero. To write the number sixty-three, people wrote 63. To write sixhundred and three, people wrote 6 3. The space was there to mean “not any” tens. Sometimes people did not remember the space. It was hard to see and to read.Later people used a dot to hold the space. Si
8、x hundred and three looked like this 63. But the dot was hard to see. So people put a circle around it like this 63. Then people could see the dot.They remembered the space.At last, only the circle around the dot was used. It was like a zero. This is one story of how the zero came to be used.Now zer
9、o has many important uses. Zero tells how many. Can you tell some other ways zero is used根据以上短文内容，判断下列各句是否符合短文内容，符合短文内容的填 T，不符合的填 F，每小题一分。() 1. At first, zero was not used by people.() 2 The space between 6 and 3 was easy to see and to read.() 3 When people wrote eight hundred and nine, they would p
10、ut a circle with a dot in it between 8 and 9.() 4 Zero came from the circle around the dot.() 5 Zero isnt useful in our life.BMy grandmother was an iron-willed woman. When I was five, she invited some friends toDuring the party, I went to the bathroom. I was still sitting down when the girl walked “
11、You have stayed here too long!”“Its none of your business. Dont you know that little girls shouldnt come into the bathroom when little boy is using it”Then she started to cry. Most guests hadShe was waiting for me when I left the bathroom. Grandmother shouted that I was impolite and rude, and ordere
12、d, “You must say sorry to her.” All the guests watched in silence.Twenty minutes later, Grandmother walked by the bathroom and noticed a lot of waterIt took several strong men a few minutes to move her away and calm down.My grandfather took me by the hand and seated me on his lap. He looked at me, n
13、ot at all angry or upset. “Tell me,” he asked, “Why did you do it”“Well, she shouted at me for nothing,” I said seriously. “Now shes got something to be angry at.”Grandfather didn “Eric,” he said at last, “I think you did the right thing.”根据短文内容，从方框中选出合适的选项填入空缺处，使短文完整、通顺。每小题两分。A. I will never forget
14、 his expressions for my whole life.B. But Grandmother didnt laugh.C. This surprised the little girl.D. Grandmother considered them the most important among the guests.E. Grandmother was so angry that she tried to get me away.五、短文填空。 （10%）阅读短文，用方框内所给单词的正确形式填空，使短文意思通顺、完整。注意：1、每个词只能用一次；2、其中有两个多余选项。not
15、speak, call, idea, and, what, garden, hear, quiet, do, eat, name, sayA farmer saw an old man growing something on the other side of the river. out to him, “What are you growing, Grandpa”for a moment, then said, “Ill tell you.” The farmer didn the old man was doing. He in his ear, “I .” “quite clearly on that side.” said the farmer. “Oh, no, I wouldn that. The sparrows（麻雀） my pears.”
