发布时间 : 星期日 文章GMP知识读本--企业员工培训教材更新完毕开始阅读6e3d27040b1c59eef8c7b47d
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. As the rocket rose into the air, we were pushed back into our seats because we were trying to escape the pull of the earth 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 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 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 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 dear 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 out on the outside of the spaceship as the earth 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, he smiled, which star would you like to go to?aughtby a black hole The spaceship warned Li Yanping and me to be ready as we were approaching the lack 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 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 stopped 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 lack hole was pulling us into itsmouth 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 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 watching 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 lack 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 escape. How exciting!Unit 5 A trip on The True NorthLi 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 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 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, but they forget the fact that Canada is 5500 kilometers from coast to coast. Here in Vancouver, youre in Canada warmest part. People say it is Canada most beautiful city, surrounded by mountains and the Pacific Ocean. Skiing in the Rocky Mountains and sailing in the harbour make Vancouver one of Canada 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 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 the 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 population 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 Lakes. 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 world 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 Montreal The 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 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. 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 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 of the Chinese people here come from South China, especially Hong Kong. It too bad you can 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 change three times on our jourill be able to move more freely. ney and that thI might even gre first change would be the most powerful. Then we werow taller if I stay here long enough. I shall certainly weigh less!e off. As the rock I laughedet ros ande into the air, we w climbed down the steps frere pushed back intom the spaceship. But when I tro our seats because we were trying to escape the pull of the earthied to step forward, I found I was carried twice as far as on th gravity. It was so hard thate earth and fell over. we could not say anything t Oh dear I cried, o each other. walking does Grad needually th a bit of practice now that grave weight lessened and I was abity hasle to t changalk to him.ed. After Why is th a while I gote spaceship not falling back to the earth? On the earth if I fall from a tree I will fall t the hang of it and we began to enjoy ourselves. Leaving the moons gravity was not aso ground. painful as leav I asked. ere approaching thed sideways ande away from thislack hole. We could see s edge of the ome faintblack hole lights ar. Someone watching me wouldound what looked like an empty space. have seen the spacesh Li Yanping sip flying likaid, Thate a bird away from the empty hole is like a mouthblack hole always need. But we felting to be fed. Thos nothing. At last we were lights are thinse able to look around us. Luckily the computer that are being pulled into time by the grav had startity of the hed working again.ole. We watch We red with interealized that weste had and amazement at the lights which discovered something new about seemed to black holee going fainter. If you go insid ande the ed fainterge of a round thblack holee edge of th, it will e black hole. Justeat you and there is then the lights on our no escape; but spaceship w if you do not, you may havent our the and the an opportunity to ese computer stopped working.e 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, but they forget the fact that Canada is 5500 kilometers from coast to coast. Here in Vancouver, youre in Canada warmest part. People say it is Canada most beautiful city, surrounded by mountains and the Pacific Ocean. Skiing in th the tear and op of Lake Superan eagle. Theirior, through the gr next stop waseat forests Calgary, which is famous for the Calgary Stampede. Cowboys fr and southward towads Toronto. The True North from om all ovTorer thonto e worldto Montreal come to compete inThe next morning the b the Stampede.ushes Many of them have a gift and maple trees outside their for riding wild hors window were redes, gold and orange, and ther and can win thousands of dollarse was fr in prost on thizes. Ae grfter two daysound, confirming that fall had arr travel, the girls began tivedo r in Canada. Around noon they arrealize that Canada is quite empty.ived At in Toront school, tho, they hade biggest and most w learned that mostealthy cit Canadians live within a few hundred kilometresy in Canada. They were not leaving for Montr of the USA bordeal until laterer, and C, so they went on a tour of the city. They went up thanadas population is only slightly overn 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 Chinese people here come from South China, especially Hong Kong. 9
It too bad you can go as far as Ottawa, Canadas capital. Its approximately four hundred kilometers northeast of Toronto, so it would take too long. But from th returning te earth now to feel its pull, o the earth was very frightening. W he explained, e watch so we feel as if thed, amazed as firere is no grave broke out on thity at all. We outsidhen we get close of the spaceship aser to the moon, we shall feel its the earth gravity increased. gravity pulling us, b Again we were pushed but it will not be as strack hard into our song a pull as the eartheats as we came back to land.s. I cheered up immed That was viately and floatery exhausting buted weightlessly ar very excitounding too, in our spaceship cab I said.Now I know much morin watching the earthe about grav become ity!Unit 5 A trip on ied tThe o tTrue urn thNorthe spaceship away frLi Daiyu and herom the h cousin Liu Qian wole but it would notere on a trip to Canad move. Woulda to bisit it eat us their too? Sudd cousinsenly the spacesh in Montreal on the Atlantip jumped and bic coast.egan t Ratho move round ther than take the aere edge of trhoplane all the hole too.e way, they d The gravitecidy of thed to fly to Vancouvere lack hole was pulling us into its and then take the trmouthain west t As tho east acrose spaceship moveds Canada. round th The though thate black hole, I felt r they could crossather s the whole ick. My ocky Mountains and sailing in the harbour make Vancouver one of Canada 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 ey were amazed to see s across the lake. uch an empty country. In the distance, they could sThey went through a wheat-gree the Misty cloud that rowing prose from thovince and se greataw far Niagara Fms thatalls cov, which is on thered thousands of acres.e south side of the lake. The water Afrer dinner, they were back in an urban area, th flows into the Niagara River and overe busy port city of Thunder the falls on its way to the sea. Bay at the top of the Great Lakes. They saw the covered stad Becausium, home of se of the Greatever Lakes, they learned, Cal famous basketball teams.anada has mor As the ey ed in Montreal
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 We are too farsmaller 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 wing the earths.Do you think we could bisit some stars next time?Of course, he smiled, which star would you like to go to?aughtby a black hole The spaceship warned Li Yanping and me to be ready as we w What was happening? I trmouth 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 movcape. How exciting!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 Rafternoon aboard the train, the cousins 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 b thirty million, but now thfresh water than any other country in the world. In fact, it has one-third of the world total fresh water, and much of it is in the Great Lakes. That night as they slept, the train rushed acrosse tall CN Tower and lookedwalked 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 downtow The train left late that night and arriva 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. As the rocket rose into the air, we were pushed back into our seats because we were trying to escape the pull of the earth 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 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 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 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 dear 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 out on the outside of the spaceship as the earth 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, he smiled, which star would you like to go to?aughtby a black hole The spaceship warned Li Yanping and me to be ready as we were approaching the lack 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 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 stopped 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 lack hole was pulling us into itsmouth 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 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 watching 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 lack 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 escape. How exciting!Unit 5 A trip on The True NorthLi 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 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 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, but they forget the fact that Canada is 5500 kilometers from coast to coast. Here in Vancouver, youre in Canada warmest part. People say it is Canada most beautiful city, surrounded by mountains and the Pacific Ocean. Skiing in the Rocky Mountains and sailing in the harbour make Vancouver one of Canada 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 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 the 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 population 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 Lakes. 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 world 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 Montreal The 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 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. 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 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 of the Chinese people here come from South China, especially Hong Kong. It too bad you can 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。
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
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. As the rocket rose into the air, we were pushed back into our seats because we were trying to escape the pull of the earth 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 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 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 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 dear 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 out on the outside of the spaceship as the earth 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, he smiled, which star would you like to go to?aughtby a black hole The spaceship warned Li Yanping and me to be ready as we were approaching the lack 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 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 stopped 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 lack hole was pulling us into itsmouth 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 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 watching 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 lack 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 escape. How exciting!Unit 5 A trip on The True NorthLi 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 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 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, but they forget the fact that Canada is 5500 kilometers from coast to coast. Here in Vancouver, youre in Canada warmest part. People say it is Canada most beautiful city, surrounded by mountains and the Pacific Ocean. Skiing in the Rocky Mountains and sailing in the harbour make Vancouver one of Canada 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 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 the 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 population 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 Lakes. 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 world 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 Montreal The 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 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. 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 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 of the Chinese people here come from South China, especially Hong Kong. It too bad you can 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 Montreal10
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. As the rocket rose into the air, we were pushed back into our seats because we were trying to escape the pull of the earth 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 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 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 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 dear 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 out on the outside of the spaceship as the earth 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, he smiled, which star would you like to go to?aughtby a black hole The spaceship warned Li Yanping and me to be ready as we were approaching the lack 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 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 stopped 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 lack hole was pulling us into itsmouth 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 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 watching 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 lack 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 escape. How exciting!Unit 5 A trip on The True NorthLi 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 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 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, but they forget the fact that Canada is 5500 kilometers from coast to coast. Here in Vancouver, youre in Canada warmest part. People say it is Canada most beautiful city, surrounded by mountains and the Pacific Ocean. Skiing in the Rocky Mountains and sailing in the harbour make Vancouver one of Canada 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 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 the 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 population 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 Lakes. 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 world 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 Montreal The 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 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. 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 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 of the Chinese people here come from South China, especially Hong Kong. It too bad you can 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 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，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研制、生产、经营、使用和监督管理的单位或者个人均必须遵守。
制定《药品管理法》的目的是为加强药品监督管理，保证药品质量，保障人体用药安全，维护人民身体健康和用药的合法权益。
其中第九条和第十六条明确规定药品生产企业、经营企业必须分别通过“GMP”、“GSP”认证，并规定了相应法律责任。对GMP、GSP等质量管理规范认证和实施提供了法律依据。
二、系列质量管理规范
药品形成是一系列的过程，过程的每一阶段均影响到药品质量。从药品的
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. As the rocket rose into the air, we were pushed back into our seats because we were trying to escape the pull of the earth 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 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 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 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 dear 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 out on the outside of the spaceship as the earth 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, he smiled, which star would you like to go to?aughtby a black hole The spaceship warned Li Yanping and me to be ready as we were approaching the lack 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 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 stopped 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 lack hole was pulling us into itsmouth 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 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 watching 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 lack 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 escape. How exciting!Unit 5 A trip on The True NorthLi 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 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 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, but they forget the fact that Canada is 5500 kilometers from coast to coast. Here in Vancouver, youre in Canada warmest part. People say it is Canada most beautiful city, surrounded by mountains and the Pacific Ocean. Skiing in the Rocky Mountains and sailing in the harbour make Vancouver one of Canada 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 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 the 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 population 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 Lakes. 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 world 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 Montreal The 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 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. 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 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 of the Chinese people here come from South China, especially Hong Kong. It too bad you can 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 Montreal11
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. As the rocket rose into the air, we were pushed back into our seats because we were trying to escape the pull of the earth 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 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 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 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 dear 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 out on the outside of the spaceship as the earth 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, he smiled, which star would you like to go to?aughtby a black hole The spaceship warned Li Yanping and me to be ready as we were approaching the lack 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 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 stopped 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 lack hole was pulling us into itsmouth 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 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 watching 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 lack 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 escape. How exciting!Unit 5 A trip on The True NorthLi 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 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 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, but they forget the fact that Canada is 5500 kilometers from coast to coast. Here in Vancouver, youre in Canada warmest part. People say it is Canada most beautiful city, surrounded by mountains and the Pacific Ocean. Skiing in the Rocky Mountains and sailing in the harbour make Vancouver one of Canada 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 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 the 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 population 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 Lakes. 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 world 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 Montreal The 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 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. 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 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 of the Chinese people here come from South China, especially Hong Kong. It too bad you can 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 研发到临床、药品生产、经营，各个过程均制定了相应的质量管理规范。包括：
——GLP
（Good Laboratory Practice ） 《药品非临床研究质量管理规范》
——GCP
（Good Clinical Practice ） 《药品临床试验质量管理规范》
——GMP
（Good Manufacturing Practice ） 《药品生产质量管理规范》 ——GSP
（Good Supplying Practice ） 《药品经营质量管理规范》 ——GAP
（Good Agriculture Practice ） 《中药材生产质量管理规范》 ——GPP
（Good Pharmaceutical Practice ） 《医疗机构制剂配制质量管理规范》
这些规范组成了药品质量保证的体系链。药品的质量保证始于新药的研制与开发，形成在药品生产过程中满足既定质量要求，防污染、混淆、差错，并在贮存、经营过程中维持其质量并指导用户正确合理用药。
其中实施GMP是制药企业药品质量保证的核心与关键，下面我们来认识到GMP。
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. As the rocket rose into the air, we were pushed back into our seats because we were trying to escape the pull of the earth 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 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 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 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 dear 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 out on the outside of the spaceship as the earth 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, he smiled, which star would you like to go to?aughtby a black hole The spaceship warned Li Yanping and me to be ready as we were approaching the lack 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 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 stopped 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 lack hole was pulling us into itsmouth 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 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 watching 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 lack 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 escape. How exciting!Unit 5 A trip on The True NorthLi 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 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 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, but they forget the fact that Canada is 5500 kilometers from coast to coast. Here in Vancouver, youre in Canada warmest part. People say it is Canada most beautiful city, surrounded by mountains and the Pacific Ocean. Skiing in the Rocky Mountains and sailing in the harbour make Vancouver one of Canada 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 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 the 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 population 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 Lakes. 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 world 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 Montreal The 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 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. 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 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 of the Chinese people here come from South China, especially Hong Kong. It too bad you can 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 Montreal12