Number : 1904010082
Class : Pharmacy C 2019
#Project7
-1. According to the text, which answer is not correct ?
1.Why is product sampling carried out ?
Answer : a. To introduce product quality
2. Which aspect of drug manufacturing enables traceability?
Answer : c. Holistic approach
3. Why do operational method and procedures have to be validated ?
Answer : d. To isolate product of high quality
-2. Complete the following sentences with the correct word or expression in bold the text in exercise 1.
1. The documentation required for all research prosses and development steps ensures the traceability of a drug.
2. A holistic approach considers laboratory and manufacturing processes and environments together and not individually.
3. Quality assurance involves all manufacturing processes GMP wich make sure the goods produced are kept at high standards.
4. Quality control involves interim and product sampling procedures, which are carrued out to check product quality.
5. At the end of every stage of product`s manufacturing process, endpoint testing is done to maintain quality standards.
6. Even a product that has been marketed for years might have to be taken off the market in a complete product recall if serious adverse reactions occur.
7. Manufacturing processes and procedures must go through periodic validation to guarantee that they are still of an acceptable standard.
8. Contaminated product are no longer pure and acceptable for sale or public used and, therefore, must be returned to the manufacturer, or destroyed.
