CHMP position statement on Creutzfeldt-Jakob disease and plasma ...
CHMP position statement on Creutzfeldt-Jakob disease and plasma ...
CHMP position statement on Creutzfeldt-Jakob disease and plasma ...
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Figure 1:<br />
Plasma-Derived Medicinal Products: estimati<strong>on</strong> of potential reducti<strong>on</strong> capacity of specific<br />
manufacturing processes<br />
Important Note: this flow diagram should be read in c<strong>on</strong>juncti<strong>on</strong> with the preceding text in 9.2.3. It is<br />
recommended to c<strong>on</strong>sult the relevant competent authorities at the milest<strong>on</strong>es in this estimati<strong>on</strong>. Give priority<br />
to studies <strong>on</strong> products with the lowest potential removal capacity.<br />
1. Theoretical c<strong>on</strong>siderati<strong>on</strong> of potential reducti<strong>on</strong> of<br />
infectivity by manufacturing process<br />
Available<br />
data is<br />
relevant<br />
to<br />
product?<br />
Yes<br />
Go to 4<br />
No<br />
2. Investigati<strong>on</strong>al studies using biochemical assays<br />
Has<br />
biochemical<br />
assay been<br />
correlated<br />
with<br />
infectivity<br />
assay?<br />
Yes<br />
Go to 4<br />
No<br />
Is the step<br />
critical for<br />
removal of<br />
infectivity?<br />
No<br />
Go to 4<br />
Yes<br />
3. C<strong>on</strong>firm investigati<strong>on</strong> with infectivity assay for critical<br />
step(s)<br />
4. Estimate reducti<strong>on</strong> capacity<br />
Is<br />
reducti<strong>on</strong><br />
capacity<br />
limited?<br />
No<br />
No further acti<strong>on</strong><br />
Yes<br />
5. C<strong>on</strong>sider additi<strong>on</strong> of step that may increase reducti<strong>on</strong><br />
capacity<br />
9.2.4. Recall of batches where informati<strong>on</strong> becomes available postd<strong>on</strong>ati<strong>on</strong><br />
In view of the lack of adequate informati<strong>on</strong> <strong>on</strong> vCJD, it is prudent to recall batches of <strong>plasma</strong>-derived<br />
medicinal products where a d<strong>on</strong>or to a <strong>plasma</strong> pool subsequently develops vCJD. Recall should also<br />
include medicinal products c<strong>on</strong>taining <strong>plasma</strong>-derived products as excipients (see also 9.2.5).<br />
However, in both cases, c<strong>on</strong>sequences for essential medicinal products where alternatives are not<br />
available will need careful c<strong>on</strong>siderati<strong>on</strong> by the competent authorities.<br />
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