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
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