Procedure for assessing the acceptability, in principle, of vaccines ...
Procedure for assessing the acceptability, in principle, of vaccines ...
Procedure for assessing the acceptability, in principle, of vaccines ...
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Three months<br />
Accepted<br />
PSF<br />
Request samples/<br />
reference/<br />
reagents <strong>for</strong><br />
test<strong>in</strong>g with<br />
relevant<br />
documentation<br />
Samples sent<br />
to contract<br />
laboratories<br />
Report<br />
Test data<br />
satisfactory?<br />
Yes<br />
Satisfactory<br />
Completion <strong>of</strong><br />
Test<strong>in</strong>g Process<br />
Figure 3. Test<strong>in</strong>g process<br />
No<br />
61<br />
Yes<br />
fur<strong>the</strong>r<br />
test<strong>in</strong>g<br />
required?<br />
No<br />
refer to adhoc<br />
vacc<strong>in</strong>e PQ<br />
committee ?<br />
No<br />
Process<br />
term<strong>in</strong>ated<br />
Yes<br />
This shape <strong>in</strong>dicates a process delay po<strong>in</strong>t where action<br />
by <strong>the</strong> manufacturer is required. Time between request to<br />
<strong>the</strong> manufacturer <strong>for</strong> <strong>in</strong><strong>for</strong>mation and its supply are not<br />
part <strong>of</strong> <strong>the</strong> process time <strong>in</strong>dicated<br />
review by ad<br />
hoc committee<br />
(see ma<strong>in</strong><br />
process chart)
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