KDMF Regulations - Apec-ahc.org
KDMF Regulations - Apec-ahc.org
KDMF Regulations - Apec-ahc.org
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Dossier Dossier for for for <strong>KDMF</strong> <strong>KDMF</strong> submission(7)<br />
submission(7)<br />
7. Data on specification and test method, test result report and<br />
used solvents<br />
7.1. Specification and test method should be written<br />
following the way of official compendium like Korean<br />
Pharmacopoeia. Other test methods should be validated.<br />
7.2. Test result report : conducted more than 3 sequential lots<br />
based on specification and test methods<br />
7.3. Data on types of <strong>org</strong>anic solvents, reason for use, criteria of<br />
residual solvents for final products, the content of solvents in<br />
products and test methods<br />
The data should be suitable for guideline ‘Guideline for residual solvents’ ※<br />
Dossier Dossier for for for <strong>KDMF</strong> <strong>KDMF</strong> submission(8, submission(8, 9)<br />
9)<br />
8. Data on Evidence that manufacturing and quality control system<br />
is good for Korea Good Manufacturing Practice (KGMP) or better<br />
☞GMP certificate<br />
9. Drug substance for test<br />
In principle, amounts for three repeated tests<br />
8
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