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 />
Manufacturing Validation<br />
Identify critical parameters<br />
Manufacturing validation protocols*<br />
Pivotal batch production records*, **<br />
Manufacturing process validation batches<br />
(n=3)<br />
‣ Three validation batch data for submissions<br />
‣ Anything less than three validation batches requires<br />
prior agreement with regulators<br />
* Required for PAI. ** NDA/BLA submissions<br />
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