GMP知识读本企业员工培训教材

《GMP知识读本企业员工培训教材》由会员分享，可在线阅读，更多相关《GMP知识读本企业员工培训教材（87页珍藏版）》请在装配图网上搜索。

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, “Lin 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：我们的使命第一章 健康、疾病与药品在日常生活中，当

27、身体出现发烧、头痛等症状时，说明我们生病了，身体不再健康。受到了疾病的困扰，必须采取办法治疗疾病。俗语说得好“生病吃药，药到病除”，所以，治疗疾病的办法就是对症下药。辞海对健康的定义：人体各器官系统发育良好、功能正常、体质健壮、精力充沛，并具有健全的身心和社会适应能力的状态。通常用人体测量、体格检查和各种生理和心理指标来衡量。辞海对疾病的定义：指人体在一定条件下，由致病因素所引起的一种复杂而有一定表现形式的病理过程。此时，在不同程度上，人体正常生理过程遭到破坏，表现为对外环境变化的适应能力降低、劳动力受到限制或丧失，并出现一系列临床症状。疾病是致病因素对人体的损害和人体对抗这些损害的防御、代偿

28、等作用的矛盾。这一矛盾的双方，在整个疾病过程中不断进行斗争，直到疾病痊愈或人体死亡时才告终结。由此可见，药品在维护我们的身体健康中起着不可替代的作用。我们身体一旦受到疾病的侵扰，都必须使用药品予以调节或治疗，才能恢复健康。大家想想，如果没有药品，当受到病患的侵扰时，我们将无力与疾病抗争，任由病魔肆虐，疾病将夺去我们的健康甚至生命。因此，健康离不开药品，我们的生活离不开药品。第二章 认识药品我们知道了药品可以治疗各种疾病，挽救生命，那么什么是药品呢?根据药品管理法第一百零二条关于药品的定义：药品是指用于预防、治疗、诊断人的疾病，有目的地调节人的生理机能并规定有适应症、用法和用量的物质，包括中药材

29、、中药饮片、中成药、化学原料药及其制剂、抗生素、生化药品、放射性药品、血清疫苗、血液制品和诊断药品等。从以上定义我们可以得知，没有任何东西其本质就是药品，只有在当人们决定用它作为预防、治疗和诊断疾病，有目的地调节生现机能时才能称其为药品。药品主要通过其内在的主要成分预防或阻止致病因素对身体的伤害这一原理为治疗疾病，从而确保人们的身体健康。药品是一种特殊商品,为什么特殊呢?从使用对象上说：它是以人为使用对象，预防、治疗、诊断人的疾病，有目的地调节人的生理机能，有规定的适用症、用法和用量要求；从使用方法上说：除外观以外，患者无法辨认其内在的质量，许多药品需要在医生的指导下使用，而不是由患者选择决定

30、。同时，药品的使用方法、数量、时间等多种因素在很大程度上决定其使用效果，因此，药品是一种特殊的商品。另外，药品还有其本身的特性：种类复杂性：药品种类有十多种，具体品种，全世界大约有20000余种，我们目前中药制剂约有5000多种，西药制剂约4000多种，由此可见，药品的种类复杂，品种繁多。药品的医用专属性：药品不是一种独立的商品，它与医学紧密结合，相辅相成，患者只有通过医生的检查诊断，并在医生的指导下合理用药，才能达到防止疾病、保护健康的目的。药品质量的严格性：药品直接关系到人们的身体健康甚至生命存亡，因此，其质量不得有半点马虎。我们必须确保药品的安全、有效、均一、稳定。安全性 指按规定的适应

31、症和用法、用量使用药品后，人体产生毒副反应的程度。大多数药品均有不同程度的毒副反应，因此，只有在衡量有效性大于毒副反应，或可解除、缓解毒副作用的情况下才可使用某种药品。假如某物质对防治、诊断疾病有效，但是对人体有致癌、致畸、致突变的严重损害，甚至致死，则不能作为药品。有效性 指在规定的适应症、用法、用量的条件下能满足预防、治疗、诊断人的疾病，有目的地调节人的生理机能的要求。疗效确切，适应症肯定，是药品质量根本的要求，是药品的基本特征。若对防治疾病没有效，则不能成为药品。有效也必须在一定前提条件下，即有一定的适应症和用法、用量。均一性 指药品质量的一致性，主要表现为物理分布方面的特性，是体现药品

32、质量标准的质量特性。药品的每一单位产品都应符合有效性、安全性的规定要求。人们用药剂量一般与药品的单位产品有密切关系，特别是有效成分在单位产品中含量很少的药品，若不均一，则可能等于没有用药，或用量过大而中毒甚至死亡。稳定性 指药品质量的稳定程度，在规定的条件下保持其有效性和安全性的能力。稳定性是药品的重要质量特性。稳定性好，有效期长，服用也方便。另外，药品的质量还有显著的特点：它不象其他商品一样，有质量等级之分：优等品、一等品、二等品、合格品等等，都可以销售，而药品只有符合规定与不符合规定之分，只有符合规定的产品才能允许销售，否则不得销售。切记：药品质量符合规定不仅是产品质量符合注册质量标准，还

33、应使其生产全过程符合药品生产质量管理规范。药品还有生产规范性、两重性、检验专业性、使用的时效性、经济性等。药品生产规范性指我们作为药品生产企业，必须遵守GMP规范，按规范生产管理。药品的两重性指药品可以治疗疾病，但是，如果我们不能正确使用药品，也会给身体带来严重后果。如阿片类药品，作为药物可以镇痛，作为毒品则能致瘾，对社会造成危害。检验的专业性是因为药品不象其他商品，消费者无法自己分辨药品的质量好坏，而必须由专业的检验人员通过专业的仪器设备分析，才能确定药品的质量是否符合要求。药品的使用时效性指药品只能在有效期内服用，超过有效期不得服用。药品的经济性指药品是一种商品，具有商品的属性经济性。它主

34、要体现在药品的流通和交换环节中，是指药品生产、流通过程形成的价格水平。国家对药品价格实行政府定价、政府指导价或者市场调节价。但要把握一个原则，药品是用来治病的，不能被制假分子用来非法牟取暴利。在以上特性中，最重要的是质量的严格性，作为药品，质量出不得任何差错，一旦出现质量问题，就可能危害我们的生命。因此在生产过程中，要严格控制药品质量，把可能影响产品质量的因素在生产过程中一一消除。87a 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, “Lin 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 a

59、t 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 Chinese people here come from South China, especially Hong Kong. Its too bad you cant go as far as Ottawa

60、, 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过程控制的有效性 入库验收、检查发放至生产部门门物料选购销售放行成品检验合格物料通过机器设备加工生产 影 响 因 素若无 生产过程环境、卫生、设备、物料管理、人员操作投诉、收回、退货、不良反应等检验准确可信库存管理及条件件下物料流程管理库存管理及条件所用物料质量 药品生产

61、的一般过程注意：图中椭圆形图案中的文字内容就是在生产过程中应该注意的因素，它可能导致产品质量不符合要求。 第三章 我们的使命认识了药品及其重要性后，我们作为药品的制造者，可以说是人类身体健康的保卫者，应当承担什么样的使命呢？药品生产企业主要由三部分组成：生产系统、质量系统和客户服务系统。在质量系统中，我们承担着质量控制和质量保证工作。如：QA人员监控整个生产过程是否按标准SOP进行生产，是否符合规范，确保产品在生产过程中的质量；检验人员按质量标准进行检验，判定药品是否符合要求等。质量系统的最终目的就是维护质量标准以及质量体系有效运作。在生产系统中，我们的任务是产品的实现。因此生产过程中就必须严

62、格按照标准进行操作，必须严防污染、混淆、差错的发生，确保生产出来的产品安全、有效、均一、稳定。在客户服务系统中，我们承担着对药品质量的跟踪和售后服务。其目的是正确指导患者用药，确保用药安全，及时反馈患者的信息以及药品的不良反应，为质量系统改进提供方向。由此可见，我们的使命就是保障药品安全、有效、均一、稳定。“好药治病，坏药要命”。作为人类身体健康的保卫者，保护为人类的身体健康是我们应尽的职责。我们的职业崇高而责任重大，我们应自觉遵守标准，提高个人修养，树立质量第一的意识，务必按照国家法规要求，进行规范化生产。第二部分 为什么要执行GMP第一章 药品质量风险与法规1961年发生了震惊世界的“反应

63、停”事件，这是20世纪波及世界的最大的药物空难事件。案例：“反应停”事件1961年，一种曾用于妊娠反应的药物“反应停”，导致成千上万的畸胎，波及世界各地，受害人数超过15000人。出生的婴儿没有臂和腿，手直接连在躯体上，形似海豹，被称为“海豹肢”。这样的畸形婴儿死亡率达50%以上。在市场上流通了6年的该药品未经严格的临床试验，并且最初生产该药的药厂曾隐瞒了收到的有关该药毒性的一百多例报告。致使一些国家如日本迟至1963年才停止使用反应停，导致了近千例畸形婴儿的出生。而美国是少数幸免于难的国家之一，原因是FDA在审查此药时发现该药品缺乏足够的临床试验资料而拒绝进口。正是该事件促使了GMP的诞生。

64、药品质量形成是一个复杂的过程，从最初的新药设计研发、临床试验到药品生产过程、药品经营过程，甚至在使用过程中，药品的质量都可能受到多种因素影响，存在设计缺陷、生产缺陷、储存不当、不正确使用等多种显现或隐藏的风险。药品的质量风险可分为三种类型：第一类是设计质量缺陷，在研发、临床试验中没有被发现，如上例“反应停”事件。第二类是生产缺陷或差错造成生产质量与设计质量不符合，或贮运不当造成生产质量不能得到维持，在药品使用前不能达到药品的安全、有效、均一和稳定。如采用了不稳定的物料，或生产过程受到污染，混合未经验证存在含量不均匀，未经验证灭菌方法，清场不彻底、贴错标签等。带来质量的风险。第三类是用药质量风险

65、，是药品在使用过程中误用、错用、滥用等或使用方法不正确造成的质量风险。要降低药品质量风险，保障人民用药健康，药品的研发、生产、经营和使用及各环节的监督管理都必须法制化、标准化、规范化。因此世界各国都建立了药品监督管理部门，制定相应法律法规，来建立健全药事管理。在我国，经过几十年的发展，已逐步形成了较为完整的药品管理法律法规体系并不断完善。一、中华人民共和国药品管理法2001年2月28日公布修订的中华人民共和国药品管理法，从2001年12月1日起实施。修订后的药品管理法共十章一百零六条，内容包括总则、药品生产企业管理、药品经营企业管理、医疗机构的药剂管理、药品管理、药品包装的管理、药品价格和广告的管理、药品监督、法律责任、附则。药品管理法是我国的药品大法，在中国境内从事药品的