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(3)<br />
submission(3)<br />
3. Data on Stability<br />
▶Stability data need to meet ‘Standard for Stability testing of<br />
medinie’.<br />
▶Stability data should include test methods and raw data<br />
Type Type<br />
Data<br />
New New drug drug or or Human Human placenta-<br />
placenta<br />
derived derived drug drug substance<br />
substance<br />
Ingredients Ingredients recognized to be<br />
changed changed by by by time time time and antibiotics<br />
Drug Drug substances<br />
substances<br />
Except Except Except for for for the the the above above<br />
above<br />
long long- long term term storage storage studies<br />
studies<br />
and and severity severity studies studies<br />
studies<br />
long long- long term term storage storage studies<br />
studies<br />
accelerated accelerated stability stability studies<br />
studies<br />
(long long long- long term term storage storage storage studies studies studies data data<br />
data<br />
for for at at least least six six months months) months<br />
Dossier Dossier for for <strong>KDMF</strong> <strong>KDMF</strong> submission(4)<br />
submission(4)<br />
submission(4)<br />
4. Manufacturing Process and Process Control<br />
4.1. Provide detailed information on the whole<br />
manufacturing process(including in- process control<br />
for each step)<br />
4.2 Data on quantities of raw materials, solvents and<br />
reagents used for each process<br />
6
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