Objective Type Questions

1. WHO guidelines for technology transfer are mentioned in which annexure of

WHO technical report series 961,2011.

a. Annexure 9 b. Annexure 7

c. Annexure 5 d. Annexure 4

2. A logical procedure that control the transfer of any process together with its

documentation and professional expertise between development and manufacture

or between manufacture sites is known as:

a. Technology transfer b. Technology development

c. Process modification d. None of the above

3. Which of the following is a characteristic of ToT as per WHO:

a. It is systematic process

b. It involves transfer of documents

c. It involves transfer of knowledge gained through development process

d. All of the above

4. The unit from where a designated product, process or method is expected to be

transferred is known as:

a. Sending unit b. Receiving unit

c. Processing unit d. None

5. Action of proving and documenting that any process procedure or method actually

and consistently leads to the expected results is known as:

a. Validation b. Qualification

c. Installation d. None of the above

86 Industrial Pharmacy II

6. Assessment of risk and controlling of risk are the steps under:

a. Quality risk management b. Quality control

c. Quality assurance d. Validation

7. Arrange the following with respect to their order of occurrence in QRH process:

1. Risk assessment 2. Risk review 3. Risk control

a. 1, 3, 2 b. 1, 2, 3

c. 3, 2, 1 d. 2, 3, 1

8. Risk reduction is a part of:

a. Risk evaluation b. Risk assessment

c. Risk control d. Risk review

9. Which ICH guidelines explain the process of QRM?

a. Q9 b. Q10

c. Q2 d. Q1

10. FTA stands for:

a. Flowchart technical analysis b. Frequent technical analysis

c. Fault tree analysis d. None of the above

11. In which of the following, the vendor has to transfer analytical method to QC:

a. If drug product is pharmacopoeial

b. If drug product is non-pharmacopoeial

c. If drug substance is pharmacopoeial

d. None

12. Match the following: