Hi Tom,
This is the information I believe is required to be submitted. I researched it online.
Chemistry Documentation
Application/compendial release requirements and batch
records.
Significant body of information available:
One batch with three months accelerated
stability data reported in supplement; one
batch on long-term stability data reported in
annual report.
Significant body of information not available:
Up to three batches with three months
accelerated stability data reported in
supplement; one batch on long-term stability
data reported in annual report.
b. Dissolution Documentation
Case B dissolution profile as described in Section III.B.2.b.
c. In Vivo Bioequivalence Documentation
Full bioequivalence study. The bioequivalence study may be
waived with an acceptable in vivo/in vitro correlation has
been verified.
3. Filing Documentation
Prior approval supplement (all information including accelerated
stability data); annual report (long-term stability data).
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Rajeev Aneja
Princeton NJ
United States
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Original Message:
Sent: 05-29-2012 14:16
From: Tom Namsavanh
Subject: Application/compendial release requirements
Hello,
In the FDA's SUPAC guidance, what does "application/compendial release requirements" mean?
In Canada, for a site change, you would provide the manufacturing process, concurrent process validation or validation protocol, analytical methods, etc.
For the US, is there an explicit list of documents required for "application/compendial release requirements" for a site change?
Thank you.
Regards,
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Tom Namsavanh RAC
Manager, Regulatory Affairs and Compliance
Canada
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