TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR
TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR
TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR
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Hypothetical Technology Transfer<br />
(Scale up Issues, Phase III and Commercial)<br />
In-Process Controls Strategy (IPC) - DP Related<br />
Should be stated in MVP and submission<br />
IPC – Process Validation<br />
Buffer: pH, tonicity, density,<br />
conductivity<br />
Final DP Solution<br />
Before and After Filtration [Drug]<br />
pH, tonicity, density, conductivity<br />
Final DP Solution<br />
BFL, MFL, EFL [Drug] & Others<br />
BF: Bioburden, Endotoxins,<br />
ASF: Endotoxins, Bulk Sterility<br />
IPC – Commercial Mfg<br />
N/A<br />
DP Solution<br />
Before Filtration [Drug]<br />
pH<br />
Final DP Solution<br />
N/A<br />
BF: Bioburden, Endotoxins,<br />
ASF: Bulk Sterility<br />
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