Kelsey,
Your question is timely, please reference the Guidance for Industry CMC Postapproval Manufacturing Changes to be documented in Annual Reports, Section 7 Miscellaneous Changes 7.1 Page 11, "Extension of the drug substance retest dating period or drug product expiration dating period based on REAL-TIME stability data from pilot-scale or larger/commercial-scale batches following an APPROVED stability protocol. The Guidance was issued March 2014.
Note the caveats, REAL-TIME stability data and APPROVED stability protocol. Hopefully your API plan included an extension of the retest dating period in a stability protocol such that you can use the annual reporting process, if not I would have a discussion with your division on the appropriate pathway to have a new stability protocol reviewed and the mechanism to submit the new data and revise the retest expiry.
Regards,
Dar
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Darlene Rosario
Principal Consultant RA, Quality and Compliance
Velocity Consulting
Ventura CA
United States
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Original Message:
Sent: 03-18-2014 17:07
From: Kelsey Frisch
Subject: Retest Date Extension Notification for API
What type of notification is required For an API Retest Extension:
Is it required to have a CBE-30 prior to implementation
OR
Does this fall under the usual minor category for notification to the FDA?
Thank you in advance for all your insights and time.
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Kelsey Frisch
Reliable Biopharmaceutical
Overland MO
United States
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