问题 单项选择题

2014年10月28~29日,总局联合地方食药监局对广东怡康制药有限公司等企业开展飞行检查。经检查发现,抗骨增生片委托韶关市居民制药有限公司生产,通过对韶关市居民制药有限公司的延伸检查,查实该企业在生产过程中抗骨增生片与氯芬黄敏片发生交叉污染,已违反《药品管理法》和药品GMP相关规定,广东省局已依法收回上述两家涉事企业的药品GMP证书,且涉事产品已启动召回措施。 抗骨增生片委托生产,对韶关市居民制药有限公司的要求,不正确的是()

A.韶关市居民制药有限公司应该严格执行质量协议,有效控制生产过程

B.韶关市居民制药有限公司应当取得委托生产药品的批准文号

C.韶关市居民制药有限公司负责委托生产药品的质量

D.韶关市居民制药有限公司确保委托生产药品及其生产负荷注册和《药品生产质量管理规范》的要求

答案

参考答案:B

解析:

1.本题考查《药品生产质量管理规范》的有关规定。现有药品生产企业血液制品、疫苗、注射剂等无菌药品的生产,应在2013年12月31日前达到《药品生产质量管理规范(2010年修订)》要求。其他类别药品的生产均应在2015年12月31日前达到《药品生产质量管理规范(2010年修订)》要求。

2.本题考查药品委托生产的界定。药品委托生产,是指药品生产企业(委托方)在因技术改造暂不具备生产条件和能力或产能不足暂不能保障市场供应的情况下,将其持有药品批准文号的药品委托其他药品生产企业(受托方)全部生产的行为,不包括部分工序的委托加工行为。接受委托生产药品的,受托方必须持有受托生产的药品相适应的GMP认证证书。

3.本题考查药品委托生产委托方的要求。委托方应当取得委托生产药品的批准文号。委托方负责委托生产药品的质量。委托方应当对受托方的生产条件、技术水平和质量管理情况进行详细考察,向受托方提供委托生产药品的技术和质量文件,确认受托方具有受托生产的条件和能力。委托生产期间,委托方应当对委托生产的全过程进行指导和监督,负责委托生产药品的批准放行。

4.本题考查药品委托生产对受托方的要求。受托方应该严格执行质量协议,有效控制生产过程,确保委托生产药品及其生产负荷注册和《药品生产质量管理规范》的要求。委托生产药品的质量标准应当执行国家药品标准,其药品名名称、剂型、规格、处方、生产工艺、原料药来源、直接接触药品的包装材料和容器、包装规格、标签、说明书、标准文号等应当与委托方持有的药品批准证明文件的内容相同。

5.本题考查药品生产有关药品召回的义务。药品生产企业是药品召回的责任主体。药品生产企业应当保存完整的购销记录,建立和完善药品召回制度,收集药品安全性的相关信息,对可能具有安全隐患的药品进行调查、评估,召回存在安全隐患的药品。进口药品的境外制药等厂商与境内药品生产企业一样也是药品召回的责任主体,履行相同的义务。

阅读理解

阅读理解。

     Of course you don't want to be sick in your vacation. So what can you do while traveling? There are

three things you should remember: relax, sleep and eat well.

     A vacation is a time for relaxing, but very often it is not. Think about what you do when you are a tourist.

There are so many places to visit: shop, parks, churches and temples (寺庙). You may spend most of the

days walking around these places. This can be very tiring. Do not ask your body to do too much. A tired body

means a weak body. A weak body gets sick easily. So sit down for a few hours in a nice place. In good

weather, look for a quiet park bench.

     Sleep is also important. If you want to stay healthy, you need to get enough sleep. Your hotel room may

be noisy, or the bed may be too hard. Or you may want to stay out late at night. Then you should plan to sleep

for an hour during the day. The extra hour can make a big difference.

     Finally, if you want to stay healthy, you must eat well. That means eating the right kinds of food. Your

body needs fresh fruit, vegetables, meat milk and cheese.

     So, remember this: if you want to enjoy your vacation, take good care of yourself. Give your body some

rest. Get enough sleep and eat healthy food.

1. You should ______ while traveling. 

A. eat well

B. walk all the time

C. do shopping

D. ask your body to do a lot.

2. Traveling is usually ______.

A. easy

B. noisy

C. tiring

D. dangerous

3. You must ______ to enjoy your traveling.

A. visit parks

B. stay healthy

C. go to churches and temples

D. sit down for a few hours

4. The underlined word "extra" means ______ here.

A. one more

B. more than one

C. usual

D. different

5. The text tells us ______ in traveling.

A. how to rest

B. what places to visit

C. how to relax and sleep

D. how to take good care of ourselves

多项选择题