How is the quality of vaccines assured by the ... - The INCLEN Trust

DCG(I)
QA Division Headed by DDC(I)
Pre-screening
On qualifying the Pre-screening, dossier will be forwarded to
Technical Division
Applicant
ADC(I)
TO/DI
ADC(I) will forward the
application to respective
TO / DI, who will mark it
to TDA, module wise
Final decision and
approval by DCG(I)
(may also call the review
team for discussion )
DCG(I)
DCGI(Drugs
Controller
General of India)
TDA
TDAs start technical
evaluation of dossiers with
the help of SOPs. And
submit the report of
evaluation to respective
TO/DI
Final approved decision
or recommendation will
be forwarded to the QA
Division for further
validation
QA
Division
DDC(Dy. Drug
Controller)
ADC(Assistant
Drug Controller)
TO/DI
TO / DI validate the
report submitted by
TDAs and prepare the
validation report and
forward to ADC vaccine
for group discussion
ADC(I) prepare Final
Executive summary for
DCG(I) on the basis of
the validation report
and group discussion
and comments of CDL
ADC(I)
DI(Drug
Inspector)/
TO (Technical
Officer)
Group Discussion
ADC vaccine is the observer
Team members: TO/DI & TDAs
NCL-CDL,
Kasuali
TDA(Technical
Data Associate)