13. Differentiates drug product
manufactured under target
conditions
VS
Formulation with meaningful
variations for the most relevant
manufacturing variablesDiscrimination
18. Manufactured
product variants
with different
release
characteristics
Select optimal
dissolution
method with
adequate
discriminating
power
Determine
bioavailability for
product variants
Determine
dissolution rates
resulting in
similar in vivo
performance
1
2
4- Determine dissolution rates resulting in similar in vivo performance
3
4
19. Manufactured
product variants
with different
release
characteristics
Select optimal
dissolution
method with
adequate
discriminating
power
Determine
bioavailability for
product variants
Determine
dissolution rates
resulting in
similar in vivo
performance
Dissolution
specifications
chosen to ensure
similar (BE)
product
performance1
2
5- Dissolution specifications chosen to ensure similar (BE) product performance
3
4
5
20. Manufactured
product variants
with different
release
characteristics
Select optimal
dissolution
method with
adequate
discriminating
power
Determine
bioavailability for
product variants
Determine
dissolution rates
resulting in
similar in vivo
performance
Dissolution
specifications
chosen to ensure
similar (BE)
product
performance
Illustration of
dissolution profile
based on BE
batches/ reference
1
2
6- Illustration of dissolution profile based on BE batches/ reference
3
4
5
6
22. Application is not supported
with dissolution method
development data
Common Deficiencies
23. Failed to demonstrate that the
dissolution method is
discriminating
Information on critical material
attributes & process parameters
are missing
Common Deficiencies
24. Data do not support the
proposed acceptance criteria
Common Deficiencies
25. There is no dissolution data for
the lower strength waiver
Multi media testing for MR
products
Common Deficiencies
26. Method transfer report is not
available when method
validation is done at different
sites
Common Deficiencies