3.2.P.5 Control of Drug Product 3.2.P.5.1 Specification(s)

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3.2.P.5
3.2.P.5.1
US = red
Control of Drug Product
Specification(s)
EU = blue
Release Specifications
Test
Identification Tests
Analytical
Procedure
Acceptance Criteria
Potency Tests
Assay B01234 Not more than 90% and not less than 110%
of label claim.
Not more than 95% and not less than 105%
of label claim.
Purity Tests
Other Tests
Physical Appearance 1 Visual It is a blue size 1 capsule.
1
“Physical Appearance” is equivalent to the ICH term “Description.”
CTD34 NDP Specs (Version 1.0) 2003
CTD Module (Chemistry, Manufacturing, and Control)
Eli Lilly and Company

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Shelf-Life Specifications
Test
Identification Tests
Analytical
Procedure
Acceptance Criteria
Potency Tests
Assay B01234 Not more than 95% and not less than 105%
of label claim.
Purity Tests
Other Tests
Physical Appearance 1 Visual It is a blue size 1 capsule.
1
“Physical Appearance” is equivalent to the ICH term “Description.”
Some of the information in this module needs to be differentiated to properly be
incorporated into the EU and the US submissions. It is suggested that global
specifications be denoted in black, EU only specifications be denoted in blue, and US
only specifications be denoted in red text.
CTD34 NDP Specs (Version 1.0) 2003
CTD Module (Chemistry, Manufacturing, and Control)
Eli Lilly and Company