问题 问答题

GSP认证过程中要求的质量管理体系文件包括哪几方面的内容?

答案

参考答案:(1) 质量管理制度,质量管理制度是药品经营企业根据GSP要求和企业质量管理工作的实际需要而制定的质量规则,是对企业各部门和各业务环节如何实施质量管理做出的明确规定。(2) 质量管理工作程序文件,质量管理工作程序文件是对购销关键环节进行管理的主要依据,是为进行某项质量活动或过程所规定的途径或方法,是对各项质量活动采取方法的具体描述。(3) 岗位质量职责,质量职责是根据GSP要求和药品经营企业质量管理工作的需要,对质量管理的各相关部门和岗位的工作内容、工作目标、工作结果等提出的明确要求,即对于相关质量管理工作明确规定由谁来做。(4) 质量记录和原始凭证,质量记录是阐明所取得的结果或提供所完成活动的证据性文件。记录可以反映工作的质和量,是工作过程的真实记载,为工作的有效性提供客观证据,在需要追溯质量相关信息时提供证据。

阅读理解

Ron Meyer is the president and COO(首席运营官) of Universal Studios.As one of the most successful business leaders in Hollywood, he heads up Universal Pictures and Universal Parks & Resorts.He's the guy who oversees the production of Multimillion-dollar extravaganzas(作品) like King Kong and Cinderella Man

Meyer’s story sounds like the plot of one of his motion pictures.He grew up in a modest home where there was little income.It was a big deal to go to a restaurant.At 15, he quit high school and spent his time hanging out with the neighborhood toughs(流氓).He was then a kid quick with his fists who seemed to get into fights somewhat regularly.At one point, he was separated from others with an infectious disease, having no TV and nothing to do.His mother sent him two books.One was The Amboy Dukes, a novel about kids in street gangs.The other was The Flesh Peddlers, about a guy in the talent agency(星探公司)who lived a successful life.“I realized,” he says, “that I was no longer that silly kid I had been, and I wanted to change my life.”

Meyer took any job he could get.He worked as a busboy and short-order cook.He cleaned offices and sold shoes.That attitude made an impression on people.One day he received a call from Paul Kohner, a successful agent who represented stars like John Huston, Charles Bronson and Lana Turner.Their messenger and driver had quit, and they knew Ron was willing to take whatever job they offered. He started the job the next day.

Meyer was lucky to work with a good boss―and he had the brains to make the most of that experience.In nearly six years of driving for Kohner, Meyer became his right-hand man and learned a lot.By the 1970s, Meyer had built many relationships in the business.In 1975, the fate presented an opportunity and he started his own operation Creative Artists Agency, which became a huge success, representing Hollywood legends like Barbra Streisand, Tom Hanks and Tom Cruise.

Twenty years later, Meyer was appointed to run Universal Studios, a position far beyond his youthful dream.But once he saw success was possible, he was driven to achieve it.Today, colleagues regularly owe his success―and theirs―to his humility and perseverance.It’s a level of success that takes determination, personality and intelligence, whether it comes from a college education or from the street.

小题1:What is the main idea of the passage? 

A.How a bitter childhood contributes to one’s success.

B.It’s important to choose a right career to achieve one’s life goal.

C.A talent agency helps a person to become famous.

D.It’s people’s determination, intelligence and personality that decide their success.小题2:What does the author mean by saying “he had the brains to make the most of that experience”?

A.He benefited a good deal from the experience.

B.He smartly took the opportunity to learn from the experience.

C.That experience made him ever smarter than ever before.

D.He used his brains to impress his boss.小题3:Which of the following is TRUE according to the passage?

A.A talent agency is to oversee the production of movies.

B.Ron Meyer did far more successfully than Raul Kohner.

C.Relationship is the most important thing in the film industry.

D.Meyer had never thought of being as successful as today.

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