TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR
TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR
TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR
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DRUG PRODUCT<br />
Stability<br />
Consult FDA prior to Pivotal Stability initiation,<br />
Use matrix if FDA Agrees<br />
Place 3 Pivotal Stability Batch: Final<br />
Formulation/s. Matrix for site/label<br />
ICH compliant stability protocol. Apply ICH<br />
Q1A,B, Q3B,C, and Q5C and others<br />
12 month long term and 6 month accelerated<br />
(15 o C above label temperature)<br />
Use validated test methods for at least pivotal<br />
stability data. Formulation can not change or<br />
repeat stability.<br />
90
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