Day 1 - US Pharmacopeial Convention
Day 1 - US Pharmacopeial Convention
Day 1 - US Pharmacopeial Convention
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Meeting The Limits – Three Approaches<br />
� Daily Dose Option<br />
– Dosage form is analyzed and meets the PDE<br />
requirements on a daily dose basis<br />
� Individual Component Option - LVPs<br />
– Each component of the dose form meets the<br />
limits established in the LVP column<br />
� Summation Option<br />
– Sum the individual component levels per<br />
equation i in i the h chapter h and d compare to Daily D il<br />
Dose PDE<br />
Some Possible Scenarios<br />
Impurity possible via the nature or source of<br />
the product (e.g., natural sources, supply<br />
chain)? )?<br />
� No - Justify documentation and testing<br />
requirements with regulatory authorities<br />
� Yes – Demonstrate control via testing or<br />
validated process on schedule agreed with<br />
regulatory authorities<br />
11/23/2010<br />
10
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