Are you proposing to use 10% of the proposed full scale production size API to make your drug product for the submission (ANDA or NDA)?
Are you proposing to manufacture the above pilot scale API (10% of full scale) in the final manufacturing site using production scale equipment?
Are you planning to validate the API full scale batches once the approval is close or final?
If the answer to the above three points is "yes" then it is 'Yes' to your question.
The risk to the above scenario is 'delayed commercialization ' if the following happens:
In case you face difficulties when scaling up and require some major CMC changes, then you cannot release the batches to make your commercial drug product batches until the CMC changes for the API are approved. I heard for ANDA, lot of companies manufacture at least one full scale production size batch. You may want to hear from generic ANDA holders on this issue.
The bottom line is that Validation of drug substance and drug product with full scale batches is a must prior to release to the market once the approval is granted.
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GRSAOnline
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Original Message:
Sent: 02-Oct-2018 13:38
From: Anonymous Member
Subject: unvalidated drug substance
This message was posted by a user wishing to remain anonymous
Can you use drug substance that has not gone through process validation to make your finished dosage form submission batches?