Biologics testing in Europe
EMEA ICH Guidelines
CPMP/ICH/295/95/ICH Topic Q5A
CPMP/ICH/294/95/ICH Topic Q5D
CHMP/BWP/157653/07
EMEA/CHMP/BWP/398498/05
Final Product Testing
CPMP/ICH/365/96 ICH Topic Q6B
Characterisation of
Bulk Harvests
Sterility conforms...
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Biologics testing in Europe
EMEA ICH Guidelines
CPMP/ICH/295/95/ICH Topic Q5A
CPMP/ICH/294/95/ICH Topic Q5D
CHMP/BWP/157653/07
EMEA/CHMP/BWP/398498/05
Final Product Testing
CPMP/ICH/365/96 ICH Topic Q6B
Characterisation of
Bulk Harvests
Sterility conforms to EP 2.
6.
1 or•
Bioburden conforming to EP 2.
6.
12
Mycoplasma complies with EP 2.
6.
7 or•
EP 2.
6.
21
in vitro• adventitious virus testing –
MRC-5, Vero and cell line of the same
species and tissue type as the production
cell line (14 day assay in the case of
non-primate cells, 28 day assay for
primate cells)
Tests for Retroviruses including PERT•
(following EP 2.
6.
21), Transmission
Electron Microscopy, Infectivity assays
Tests for species specific testing i.
e.
•
Mouse minute virus or Cache Valley virus
Once only –• in vivo adventitious
virus testing in adult and suckling
mice and embryonated chickens eggs
(may also include Guinea Pigs where
appropriate)
Sterility conforming to EP 2.
6.
1•
pH conforms to EP 2.
2.
3•
Vis
Less
