KDMF Regulations - Apec-ahc.org
KDMF Regulations - Apec-ahc.org
KDMF Regulations - Apec-ahc.org
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<strong>KDMF</strong> <strong>KDMF</strong> Holder Holder Holder Obligations(1)<br />
Obligations(1)<br />
• Annual Update<br />
<strong>KDMF</strong> holder should submit an annual report to<br />
KDFM by the end of Jan. every year. This report<br />
should include all changes to the DMF data.<br />
<strong>KDMF</strong> <strong>KDMF</strong> Holder Holder Obligations(2)<br />
Obligations(2)<br />
▶ Amendment is necessary when you have any changes<br />
such as ...<br />
ⓐ manufacturing site<br />
ⓑ storage condition(including packaging material) and<br />
expiration date<br />
ⓒ major manufacturing process<br />
ⓓ batch size(more than 10 times)<br />
ⓔ specification and test methods different from<br />
Official Compendium such as KP and USP<br />
�19<br />
10
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