问题 单项选择题

依照《医疗机构制剂配制质量管理规范(试行)》,制剂配制的管理文件主要有()。

A.质量标准、检验操作规程、制剂质量稳定性考察记录和检验记录

B.配制规程、检验操作规程和检验记录

C.配制记录和检验记录

D.配制规程、标准操作规程和配制记录

E.配制规程和制剂质量稳定性考察记录

答案

参考答案:D

解析:本组题考查要点是"制剂配制的管理文件和配制制剂的质量管理文件的内容"。《医疗机构制剂配制质量管理规范(试行)》第五十条规定,制剂配制管理文件主要有:(1)配制规程和标准操作规程。①配制规程包括:制剂名称、剂型、处方、配制工艺的操作要求,原料、中间产品、成品的质量标准和技术参数及储存注意事项,成品容器、包装材料的要求等;②标准操作规程:配制过程中涉及的单元操作(如加热、搅拌、振摇、混合等)具体规定和应达到的要求。(2)配制记录。包括:编号、制剂名称、配制日期、制剂批号、有关设备名称与操作记录、原料用量、成品和半成品数量、配制过程的控制记录及特殊情况处理记录和各工序的操作者、复核者、清场者的签名等。第五十一条规定,配制制剂的质量管理文件主要有:①物料、半成品、成品的质量标准和检验操作规程;②制剂质量稳定性考察记录;③检验记录。

单项选择题 A1型题
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     "In only six days I lost seven pounds of weight."

     "Two full inches in the first three days!"

     These are the kinds of statements used in magazine, newspaper, radio and television ads, promising

new shapes and new looks to those who buy the medicine or the device.The promoters of products say

they can shape the legs, slim the face, smooth wrinkles, or in some other way to add to beauty or

desirability.

     Often such products are nothing more than moneymaking things for their promoters.The results they

produce are questionable, and some are dangerous to health.

      To understand how these products can be legally promoted to the public, it is necessary to

understand something of the laws covering their regulation.If the product is a drug, FDA(Food and Drug

Administration)can require proof under the Food, Drug, and Cosmetic Act that is safe and effective

before it is put on the market.But if the product is a device, FDA has no authority to require premarketing proof of safety or effectiveness.If a product already on the market is a danger to health, FDA can request

the producer or distributor to remove it from the market voluntarily, or it can take legal action, including

seizure(查封)of the product.

     One notable case a few years ago involved an electrical device called the Relaxacisor, which had

been sold for reducing the waistline.The Relaxacisor produced electrical shocks to the body through

contact pads.FDA took legal action against the distributor to stop the sale of the device on the grounds

that it was dangerous to health and life.

    Obviously, most of the devices on the market have never been the subject of court proceedings(法律

诉讼), and new devices appear continually.Before buying, it is up to the consumer to judge the safety or

effectiveness of such items.

1. It can be inferred that the ads mentioned in the text are________.

A. objective  

B. costly

C. unreliable 

D. illegal

2.Which of the following is TRUE according to the text?

A. The court is in charge of removing dangerous products.

B. New products are more likely to be questionable.

C. The production of a device must be approved by FDA.

D. The promoters usually just care about profits.

3. FDA can ask for the proof of safety and effectiveness of a product________.

A. if it is a drug

B. if it is a device

C. if its consumers make complaints

D. if its distributors challenge FDA's authority

4. The Relaxacisor is mentioned as________.

A. a product which was designed to produce electricity

B. a product whose distributor was involved in a legal case

C. a successful advertisement of a beauty product

D. an example of a quality beauty product