RE: RE: RE: RE: RE: RE: Inquiry - SUPAC evaluation for Modified Release product Contribution from Vamshi written on 8/30/2010 at 02:03
Original contribution: RE: RE: RE: RE: RE: Inquiry - SUPAC evaluation for Modified Release product written by Deepak Kheni on 8/28/2010 at 09:21) So the coating solution is just used for the appearance...excellent...then its not a major change.
I got your email. I was doing some search for guidance on this subject.
FDA recently issued a Draft-Not for Implementation guidance titled "CMC Postapproval Manufacturing Changes Reportable in Annual Reports". You can find it in the below link:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM217043.pdf
As per that guidance, deletion or reduction of an overage in a batch formula can be reported in a annual report. see appendix A:
EXACT Sentence from the Guidance:
1.
Components and Composition
1.1. Elimination or reduction of an overage from the drug product manufacturing batch formula that was previously used to compensate for manufacturing losses. Note that this does not apply to loss of potency during storage."
So you can file this change in an annual report. But make sure you submit all the below mentioned information in the AR.
This description should include a (1) list of each change by the date the change was made; (2) relevant summary of data from studies and tests performed to evaluate the effects of the change, including cross references to validation protocols and standard operating procedures and policies; and (3) list of all drug products involved. The applicant should describe each change in an annual report in enough detail to allow us to quickly determine whether the appropriate reporting category has been used.
I guess this answers your question. Feel free to write me if you have any other questions related to CMC.
I strongly recommend discussing this topic with you regulatory head in your company.
Good luck.
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