Terminology Belongs to

a. TOT i. QRM tool

b. HACCP ii. Documentation

c. Risk control iii. Open and closed part

d. FMEA iv. Risk acceptance

e. DMF v. Critical control point determination

13. Fill in the blanks

a. “What can be done to reduce or climate risk?” is answered by ___________.

b. __________ ICH guidelines deal with QRM.

c. ___________ QRM tool is based on the assumption that events are caused due to

deviation in design.

d. __________ is a critical step that ensures RU capabilities to produce and test the

same product as by SU.

e. AMT will be started by ___________ department.

f. AMTP stands for __________

ANSWERS

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

9. a 10. c 11. b 12. a (ii), b(v), c(iv), d(i), e(iii)

13. (a) Risk control (b) Q9 (c) HAZOP (d) AMT (e) Analytical (f) Analytical Method

Transfer Protocol.

Regulation of Transfer of Technology 87

6.1 AUTHORITIES AND AGENCIES INVOLVED IN TOT

The main concern of authorities and agencies involved in TOT is to ensure transfer of

efficient, quality, and safe technology. Government, as well as private (belongs to SU

or RU) agencies, and authorities are involved in TOT (Fig. 6.1)

TT team: As we know that technology transfer is a multidisciplinary approach which

involves representatives and individuals from different departments (Table 6.1) like

i. R&D

ii. QA

iii. QC

iv. Production

v. Engineering

vi. Regulatory affairs

vii. The material management

viii. The project management

87

Regulation of Transfer of

Technology

6