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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Satisfactory<br />
Completion <strong>of</strong> PSF<br />
review<br />
Yes<br />
Figure 4. Site audit<br />
Schedule<br />
site audit<br />
Site audit<br />
Draft Report<br />
(delivered at exit<br />
meet<strong>in</strong>g)<br />
F<strong>in</strong>al Report<br />
Critical<br />
deficiencies<br />
found?<br />
No<br />
Additional<br />
Data<br />
Required?<br />
Yes<br />
Request/supply<br />
<strong>of</strong> Additional<br />
Data<br />
Review <strong>of</strong><br />
additional data<br />
satisfactory?<br />
Yes<br />
Follow-up<br />
site visit<br />
required?<br />
No<br />
No<br />
Yes<br />
Satisfactory<br />
Completion <strong>of</strong><br />
Test<strong>in</strong>g Process<br />
62<br />
Process<br />
term<strong>in</strong>ated<br />
Satisfactory<br />
completion <strong>of</strong> site<br />
audit process<br />
review by ad<br />
hoc committee<br />
(see ma<strong>in</strong><br />
process chart)<br />
Yes<br />
refer to adhoc<br />
vacc<strong>in</strong>e PQ<br />
committee ?<br />
Two months<br />
One month<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 />
No
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