a. Buy-back contract

b. Original equipment manufacture

c. Turnkey agreement

d. Support contract

10. Which of the following is not a good reason for technology transfer?

a. Lack of financial resources

b. Lack of manufacturing resources

c. Inferior technology

d. Lack of marketing staff

11. Validation and production aim is to:

a. Verify if the process is able to consistently manufacture the product

b. Monitor scale-up

c. Select staff

d. All of the above

12 Arrange the following in accordance with their occurrence during technology

transfer process:

Technology assessment, economical negotiations, document verification, data

collection, MoU, signature of legal rights based on negotiations.

Technology Development and Transfer 59

13. Match the following:

Content Belongs to

a. Development of technology i. Development phase

by R&D department

b. Validation ii. Documentation

c. Technology transfer to production iii. Research phase

d. Preparation of technology transfer dossier iv. Production phase

ANSWERS

1. c 2. d 3. c 4. a 5. b 6. a 7. b 8. b

9. c 10. c 11. a

12. Data collection, technology assessment, documents verifications, economical

negotiations, transfer of all legal rights based on negotiations MoU signature.

13. a (iii), b (iv), c (i), d (ii).

60 Industrial Pharmacy II

WHO GUIDELINES FOR TECHNOLOGY TRANSFER

WHO guidelines for technology transfer are mentioned in Annexure 7 of WHO

technical report series No 961, 2011 as “WHO guidelines on transfer of technology in

pharmaceutical manufacturing”.