GMP知識讀本企業(yè)員工培訓(xùn)教材

1、a chance to make a trip into space with my friend li yanping, an astronomer. we visited the moon in our spaceship!before we leave, li yanping explained to me that the forece of the gravity would change three times on our journey and that the first change would be the most powerful. then we were off.

2、 as the rocket rose into the air, we were pushed back into our seats because we were trying to escape the pull of the earths gravity. it was so hard that we could not say anything to each other. gradually the weight lessened and i was able to talk to him. “ why is the spaceship not falling back to t

3、he earth? on the earth if i fall from a tree i will fall to ground.” i asked. “ we are too far from the earth now to feel its pull, “ he explained, “ so we feel as if there is no gravity at all. when we get closer to the moon, we shall feel its gravity pulling us, but it will not be as strong a pull

4、 as the earths. “ i cheered up immediately and floated weightlessly around in our spaceship cabin watching the earth become smaller and the moon larger.when we got there, i wanted to explore immediately. “ come on,” i said. “ if you are right, my mass will be less than on the earth because the moon

5、is smaller and i will be able to move more freely. i might even grow taller if i stay here long enough. i shall certainly weigh less!” i laughed and climbed down the steps from the spaceship. but when i tried to step forward, i found i was carried twice as far as on the earth and fell over. “ oh dea

6、r,” i cried, “ walking does need a bit of practice now that gravity has changed.” after a while i got the hang of it and we began to enjoy ourselves.leaving the moons gravity was not as painful as leaving the earths. but returning to the earth was very frightening. we watched, amazed as fire broke o

7、ut on the outside of the spaceship as the earths gravity increased. again we were pushed back hard into our seats as we came back to land. “ that was very exhausting but very exciting too,” i said. “now i know much more about gravity! do you think we could bisit some stars next time?” “of course,” h

8、e smiled, “ which star would you like to go to?”caught by a black holethe spaceship warned li yanping and me to be ready as we were approaching the “black hole”. we could see some faint lights around what looked like an empty space. li yanping said, “ that empty hole is like a mouth always needing t

9、o be fed. those lights are thins that are being pulled into time by the gravity of the hole.” we watched with interest and amazement at the lights which seemed to be going fainter and fainter round the edge of the black hole. just then the lights on our spaceship went our the and the computer stoppe

10、d working. what was happening? i tried to turn the spaceship away from the hole but it would not move. would it eat us too?suddenly the spaceship jumped and began to move round the edge of trhe hole too. the gravity of the “black hole” was pulling us into its “mouth”. as the spaceship moved round th

11、e black hole, i felt rather sick. my mouth went dry and i closed my eyes. all the stories about what happened when you were caught by the gravity of a “black hole” seem to be true.but then the spaceship jumped again. this time it moved sideways and away from this edge of the “black hole”. someone wa

12、tching me would have seen the spaceship flying like a bird away from the “black hole”. but we felt nothing. at last we were able to look around us. luckily the computer had started working again. we realized that we had discovered something new about “black hole”. if you go inside the edge of a “bla

13、ck hole”, it will “eat” you and there is no escape; but if you do not, you may have an opportunity to escape. how exciting!unit 5a trip on “ the true north”li daiyu and her cousin liu qian were on a trip to canada to bisit their cousins in montreal on the atlantic coast. rather than take the aeropla

14、ne all the way, they decided to fly to vancouver and then take the train west to east across canada. the though that they could cross the whole continent was exciting.their friend, danny lin, was waiting at the airport. he was going to take them and their baggage to catch “the true north”, the cross

15、 canada train. on the way to the statiion, he chatted about their trip. “youre going to see some great scenery. going eastward, youll pass mountains and thousands of lakes and forests, as well as wide rivers and large cities. some people have the idea that you can cross canda in less than fice days,

16、 but they forget the fact that canada is 5500 kilometers from coast to coast. here in vancouver, youre in canadas warmest part. people say it is canadas most beautiful city, surrounded by mountains and the pacific ocean. skiing in the rocky mountains and sailing in the harbour make vancouver one of

17、canadas most popular cities to live in. its population is increasing rapidly. the coast north of vancouver has some of the oldest and most beautiful forests in the world. it is so wet there that the trees are extremely tall, some measuring over 90 metres.”that afternoon aboard the train, the cousins

18、 settled down in their seats. earlier that day, when they crossed the rocky mountains, they managed to catch sight of some mountain goats and even a grizzly bear and an eagle. their next stop was calgary, which is famous for the calgary stampede. cowboys from all over the world come to compete in th

19、e stampede. many of them have a gift for riding wild horses and can win thousands of dollars in prizes.after two days travel, the girls began to realize that canada is quite empty. at school, they had learned that most canadians live within a few hundred kilometres of the usa border, and canadas pop

20、ulation is only slightly over thirty million, but now they were amazed to see such an empty country. they went through a wheat-growing province and saw farms that covered thousands of acres. afrer dinner, they were back in an urban area, the busy port city of thunder bay at the top of the great lake

21、s. because of the great lakes, they learned, canada has more fresh water than any other country in the world. in fact, it has one-third of the worlds total fresh water, and much of it is in the great lakes.that night as they slept, the train rushed across the top of lake superior, through the great

22、forests and southward towads toronto.“the true north” from toronto to montrealthe next morning the bushes and maple trees outside their window were red, gold and orange, and there was frost on the ground, confirming that fall had arrived in canada.around noon they arrived in toronto, the biggest and

23、 most wealthy city in canada. they were not leaving for montreal until later, so they went on a tour of the city. they went up the tall cn tower and looked across the lake. in the distance, they could see the misty cloud that rose from the great niagara falls, which is on the south side of the lake.

24、 the water flows into the niagara river and over the falls on its way to the sea.they saw the covered stadium, home of several famous basketball teams. as they walked north from the harbour area, li daiyu said, “l(fā)in fang, one of my mothers old schoolmates, lives here. i should phone her from a telep

25、hone booth.”they met lin fei around dusk in downtown chinatown, one of the three in toronto. over dinner at a restaurant called the pink pearl, the cousins chatted with lin fei, who had moved to canada many years earlier. “we can get good cantonese food here,” lin feitold them, “ because most of the

26、 chinese people here come from south china, especially hong kong. its too bad you cant go as far as ottawa, canadas capital. its approximately four hundred kilometers northeast of toronto, so it would take too long.”the train left late that night and arrived in montreal第一部分：我們的使命第一章 健康、疾病與藥品在日常生活中，當(dāng)

27、身體出現(xiàn)發(fā)燒、頭痛等癥狀時(shí)，說明我們生病了，身體不再健康。受到了疾病的困擾，必須采取辦法治療疾病。俗語說得好“生病吃藥，藥到病除”，所以，治療疾病的辦法就是對癥下藥。辭海對健康的定義：人體各器官系統(tǒng)發(fā)育良好、功能正常、體質(zhì)健壯、精力充沛，并具有健全的身心和社會適應(yīng)能力的狀態(tài)。通常用人體測量、體格檢查和各種生理和心理指標(biāo)來衡量。辭海對疾病的定義：指人體在一定條件下，由致病因素所引起的一種復(fù)雜而有一定表現(xiàn)形式的病理過程。此時(shí)，在不同程度上，人體正常生理過程遭到破壞，表現(xiàn)為對外環(huán)境變化的適應(yīng)能力降低、勞動力受到限制或喪失，并出現(xiàn)一系列臨床癥狀。疾病是致病因素對人體的損害和人體對抗這些損害的防御、代償

28、等作用的矛盾。這一矛盾的雙方，在整個(gè)疾病過程中不斷進(jìn)行斗爭，直到疾病痊愈或人體死亡時(shí)才告終結(jié)。由此可見，藥品在維護(hù)我們的身體健康中起著不可替代的作用。我們身體一旦受到疾病的侵?jǐn)_，都必須使用藥品予以調(diào)節(jié)或治療，才能恢復(fù)健康。大家想想，如果沒有藥品，當(dāng)受到病患的侵?jǐn)_時(shí)，我們將無力與疾病抗?fàn)?，任由病魔肆虐，疾病將奪去我們的健康甚至生命。因此，健康離不開藥品，我們的生活離不開藥品。第二章 認(rèn)識藥品我們知道了藥品可以治療各種疾病，挽救生命，那么什么是藥品呢?根據(jù)藥品管理法第一百零二條關(guān)于藥品的定義：藥品是指用于預(yù)防、治療、診斷人的疾病，有目的地調(diào)節(jié)人的生理機(jī)能并規(guī)定有適應(yīng)癥、用法和用量的物質(zhì)，包括中藥材

29、、中藥飲片、中成藥、化學(xué)原料藥及其制劑、抗生素、生化藥品、放射性藥品、血清疫苗、血液制品和診斷藥品等。從以上定義我們可以得知，沒有任何東西其本質(zhì)就是藥品，只有在當(dāng)人們決定用它作為預(yù)防、治療和診斷疾病，有目的地調(diào)節(jié)生現(xiàn)機(jī)能時(shí)才能稱其為藥品。藥品主要通過其內(nèi)在的主要成分預(yù)防或阻止致病因素對身體的傷害這一原理為治療疾病，從而確保人們的身體健康。藥品是一種特殊商品,為什么特殊呢?從使用對象上說：它是以人為使用對象，預(yù)防、治療、診斷人的疾病，有目的地調(diào)節(jié)人的生理機(jī)能，有規(guī)定的適用癥、用法和用量要求；從使用方法上說：除外觀以外，患者無法辨認(rèn)其內(nèi)在的質(zhì)量，許多藥品需要在醫(yī)生的指導(dǎo)下使用，而不是由患者選擇決定

30、。同時(shí)，藥品的使用方法、數(shù)量、時(shí)間等多種因素在很大程度上決定其使用效果，因此，藥品是一種特殊的商品。另外，藥品還有其本身的特性：種類復(fù)雜性：藥品種類有十多種，具體品種，全世界大約有20000余種，我們目前中藥制劑約有5000多種，西藥制劑約4000多種，由此可見，藥品的種類復(fù)雜，品種繁多。藥品的醫(yī)用專屬性：藥品不是一種獨(dú)立的商品，它與醫(yī)學(xué)緊密結(jié)合，相輔相成，患者只有通過醫(yī)生的檢查診斷，并在醫(yī)生的指導(dǎo)下合理用藥，才能達(dá)到防止疾病、保護(hù)健康的目的。藥品質(zhì)量的嚴(yán)格性：藥品直接關(guān)系到人們的身體健康甚至生命存亡，因此，其質(zhì)量不得有半點(diǎn)馬虎。我們必須確保藥品的安全、有效、均一、穩(wěn)定。安全性 指按規(guī)定的適應(yīng)

31、癥和用法、用量使用藥品后，人體產(chǎn)生毒副反應(yīng)的程度。大多數(shù)藥品均有不同程度的毒副反應(yīng)，因此，只有在衡量有效性大于毒副反應(yīng)，或可解除、緩解毒副作用的情況下才可使用某種藥品。假如某物質(zhì)對防治、診斷疾病有效，但是對人體有致癌、致畸、致突變的嚴(yán)重?fù)p害，甚至致死，則不能作為藥品。有效性 指在規(guī)定的適應(yīng)癥、用法、用量的條件下能滿足預(yù)防、治療、診斷人的疾病，有目的地調(diào)節(jié)人的生理機(jī)能的要求。療效確切，適應(yīng)癥肯定，是藥品質(zhì)量根本的要求，是藥品的基本特征。若對防治疾病沒有效，則不能成為藥品。有效也必須在一定前提條件下，即有一定的適應(yīng)癥和用法、用量。均一性 指藥品質(zhì)量的一致性，主要表現(xiàn)為物理分布方面的特性，是體現(xiàn)藥品

32、質(zhì)量標(biāo)準(zhǔn)的質(zhì)量特性。藥品的每一單位產(chǎn)品都應(yīng)符合有效性、安全性的規(guī)定要求。人們用藥劑量一般與藥品的單位產(chǎn)品有密切關(guān)系，特別是有效成分在單位產(chǎn)品中含量很少的藥品，若不均一，則可能等于沒有用藥，或用量過大而中毒甚至死亡。穩(wěn)定性 指藥品質(zhì)量的穩(wěn)定程度，在規(guī)定的條件下保持其有效性和安全性的能力。穩(wěn)定性是藥品的重要質(zhì)量特性。穩(wěn)定性好，有效期長，服用也方便。另外，藥品的質(zhì)量還有顯著的特點(diǎn)：它不象其他商品一樣，有質(zhì)量等級之分：優(yōu)等品、一等品、二等品、合格品等等，都可以銷售，而藥品只有符合規(guī)定與不符合規(guī)定之分，只有符合規(guī)定的產(chǎn)品才能允許銷售，否則不得銷售。切記：藥品質(zhì)量符合規(guī)定不僅是產(chǎn)品質(zhì)量符合注冊質(zhì)量標(biāo)準(zhǔn)，還

33、應(yīng)使其生產(chǎn)全過程符合藥品生產(chǎn)質(zhì)量管理規(guī)范。藥品還有生產(chǎn)規(guī)范性、兩重性、檢驗(yàn)專業(yè)性、使用的時(shí)效性、經(jīng)濟(jì)性等。藥品生產(chǎn)規(guī)范性指我們作為藥品生產(chǎn)企業(yè)，必須遵守gmp規(guī)范，按規(guī)范生產(chǎn)管理。藥品的兩重性指藥品可以治療疾病，但是，如果我們不能正確使用藥品，也會給身體帶來嚴(yán)重后果。如阿片類藥品，作為藥物可以鎮(zhèn)痛，作為毒品則能致癮，對社會造成危害。檢驗(yàn)的專業(yè)性是因?yàn)樗幤凡幌笃渌唐?，消費(fèi)者無法自己分辨藥品的質(zhì)量好壞，而必須由專業(yè)的檢驗(yàn)人員通過專業(yè)的儀器設(shè)備分析，才能確定藥品的質(zhì)量是否符合要求。藥品的使用時(shí)效性指藥品只能在有效期內(nèi)服用，超過有效期不得服用。藥品的經(jīng)濟(jì)性指藥品是一種商品，具有商品的屬性經(jīng)濟(jì)性。它主

34、要體現(xiàn)在藥品的流通和交換環(huán)節(jié)中，是指藥品生產(chǎn)、流通過程形成的價(jià)格水平。國家對藥品價(jià)格實(shí)行政府定價(jià)、政府指導(dǎo)價(jià)或者市場調(diào)節(jié)價(jià)。但要把握一個(gè)原則，藥品是用來治病的，不能被制假分子用來非法牟取暴利。在以上特性中，最重要的是質(zhì)量的嚴(yán)格性，作為藥品，質(zhì)量出不得任何差錯，一旦出現(xiàn)質(zhì)量問題，就可能危害我們的生命。因此在生產(chǎn)過程中，要嚴(yán)格控制藥品質(zhì)量，把可能影響產(chǎn)品質(zhì)量的因素在生產(chǎn)過程中一一消除。89a chance to make a trip into space with my friend li yanping, an astronomer. we visited the moon in our sp

35、aceship!before we leave, li yanping explained to me that the forece of the gravity would change three times on our journey and that the first change would be the most powerful. then we were off. as the rocket rose into the air, we were pushed back into our seats because we were trying to escape the

36、pull of the earths gravity. it was so hard that we could not say anything to each other. gradually the weight lessened and i was able to talk to him. “ why is the spaceship not falling back to the earth? on the earth if i fall from a tree i will fall to ground.” i asked. “ we are too far from the ea

37、rth now to feel its pull, “ he explained, “ so we feel as if there is no gravity at all. when we get closer to the moon, we shall feel its gravity pulling us, but it will not be as strong a pull as the earths. “ i cheered up immediately and floated weightlessly around in our spaceship cabin watching

38、 the earth become smaller and the moon larger.when we got there, i wanted to explore immediately. “ come on,” i said. “ if you are right, my mass will be less than on the earth because the moon is smaller and i will be able to move more freely. i might even grow taller if i stay here long enough. i

39、shall certainly weigh less!” i laughed and climbed down the steps from the spaceship. but when i tried to step forward, i found i was carried twice as far as on the earth and fell over. “ oh dear,” i cried, “ walking does need a bit of practice now that gravity has changed.” after a while i got the

40、hang of it and we began to enjoy ourselves.leaving the moons gravity was not as painful as leaving the earths. but returning to the earth was very frightening. we watched, amazed as fire broke out on the outside of the spaceship as the earths gravity increased. again we were pushed back hard into ou

41、r seats as we came back to land. “ that was very exhausting but very exciting too,” i said. “now i know much more about gravity! do you think we could bisit some stars next time?” “of course,” he smiled, “ which star would you like to go to?”caught by a black holethe spaceship warned li yanping and

42、me to be ready as we were approaching the “black hole”. we could see some faint lights around what looked like an empty space. li yanping said, “ that empty hole is like a mouth always needing to be fed. those lights are thins that are being pulled into time by the gravity of the hole.” we watched w

43、ith interest and amazement at the lights which seemed to be going fainter and fainter round the edge of the black hole. just then the lights on our spaceship went our the and the computer stopped working. what was happening? i tried to turn the spaceship away from the hole but it would not move. wou

44、ld it eat us too?suddenly the spaceship jumped and began to move round the edge of trhe hole too. the gravity of the “black hole” was pulling us into its “mouth”. as the spaceship moved round the black hole, i felt rather sick. my mouth went dry and i closed my eyes. all the stories about what happe

45、ned when you were caught by the gravity of a “black hole” seem to be true.but then the spaceship jumped again. this time it moved sideways and away from this edge of the “black hole”. someone watching me would have seen the spaceship flying like a bird away from the “black hole”. but we felt nothing

46、. at last we were able to look around us. luckily the computer had started working again. we realized that we had discovered something new about “black hole”. if you go inside the edge of a “black hole”, it will “eat” you and there is no escape; but if you do not, you may have an opportunity to esca

47、pe. how exciting!unit 5a trip on “ the true north”li daiyu and her cousin liu qian were on a trip to canada to bisit their cousins in montreal on the atlantic coast. rather than take the aeroplane all the way, they decided to fly to vancouver and then take the train west to east across canada. the t

48、hough that they could cross the whole continent was exciting.their friend, danny lin, was waiting at the airport. he was going to take them and their baggage to catch “the true north”, the cross canada train. on the way to the statiion, he chatted about their trip. “youre going to see some great sce

49、nery. going eastward, youll pass mountains and thousands of lakes and forests, as well as wide rivers and large cities. some people have the idea that you can cross canda in less than fice days, but they forget the fact that canada is 5500 kilometers from coast to coast. here in vancouver, youre in

50、canadas warmest part. people say it is canadas most beautiful city, surrounded by mountains and the pacific ocean. skiing in the rocky mountains and sailing in the harbour make vancouver one of canadas most popular cities to live in. its population is increasing rapidly. the coast north of vancouver

51、 has some of the oldest and most beautiful forests in the world. it is so wet there that the trees are extremely tall, some measuring over 90 metres.”that afternoon aboard the train, the cousins settled down in their seats. earlier that day, when they crossed the rocky mountains, they managed to cat

52、ch sight of some mountain goats and even a grizzly bear and an eagle. their next stop was calgary, which is famous for the calgary stampede. cowboys from all over the world come to compete in the stampede. many of them have a gift for riding wild horses and can win thousands of dollars in prizes.aft

53、er two days travel, the girls began to realize that canada is quite empty. at school, they had learned that most canadians live within a few hundred kilometres of the usa border, and canadas population is only slightly over thirty million, but now they were amazed to see such an empty country. they

54、went through a wheat-growing province and saw farms that covered thousands of acres. afrer dinner, they were back in an urban area, the busy port city of thunder bay at the top of the great lakes. because of the great lakes, they learned, canada has more fresh water than any other country in the wor

55、ld. in fact, it has one-third of the worlds total fresh water, and much of it is in the great lakes.that night as they slept, the train rushed across the top of lake superior, through the great forests and southward towads toronto.“the true north” from toronto to montrealthe next morning the bushes

56、and maple trees outside their window were red, gold and orange, and there was frost on the ground, confirming that fall had arrived in canada.around noon they arrived in toronto, the biggest and most wealthy city in canada. they were not leaving for montreal until later, so they went on a tour of th

57、e city. they went up the tall cn tower and looked across the lake. in the distance, they could see the misty cloud that rose from the great niagara falls, which is on the south side of the lake. the water flows into the niagara river and over the falls on its way to the sea.they saw the covered stad

58、ium, home of several famous basketball teams. as they walked north from the harbour area, li daiyu said, “l(fā)in fang, one of my mothers old schoolmates, lives here. i should phone her from a telephone booth.”they met lin fei around dusk in downtown chinatown, one of the three in toronto. over dinner at a restaurant called the pink pearl, the cousins chatted with lin fei, who had moved to canada many years earlier. “we can get good cantonese food here,” lin feitold them, “ because most