1. Why is product sampling carried out?
a. To introduce product quality.
b. To check product quality.
c. To make sure SOPs are followed.
d. To meet high industry standards.
Answer : A
2. Which aspect of drug manufacturing enables traceability?
a. Quality assurance
b. Quality control
c. Holistic approach
d. Documentation
Answer : C
3. Why do operational methods and procedures have to be validated?
a. To complete the quality assurance process.
b. To make sure products perform their intended function.
c. To complete the inspection process.
d. To isolate products of high quality
Answer : D
2 Complete the following sentences with the correct word or expression in bold from the text in exercise 1.
1. The documentation required for all research processes and development steps ensures the __ of a drug.
Answer : Traceability
2. A __ considers laboratory and manufacturing processes and environments. together and not individually.
Answer : Holistic Approach
3. Quality ___ involves all manufacturing processes in GMP which make sure the goods produced are kept at high standards.
Answer : Assurance
4. Quality _ involves interim and product sampling procedures, which are carried out to check product quality.
Answer : Control
5. At the end of every stage of a product's manufacturing process, __ is done to maintain quality standards.
Answer : Endpoint testing
6. Even a product that has been marketed for years might have to be taken off the market in a __ if serious adverse reactions occur.
Answer : Product recall
7. Manufacturing processes and procedures must go through periodic __ to guarantee that they are still of an acceptable standard.
Answer : Validation
8. __ products are no longer pure and acceptable for sale or public use and therefore, must be returned to the manufacturer, or destroved.
Answer : Contaminated
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