C. STATEMENT OF
COMMITMENT
This signed statement would
certify compliance with Title 21 of the Code of Federal Regulations good
manufacturing practices. It includes statements declaring that products will be
manufactured according to the specifications and methods described in the drug
substance DMF and amendments. It establishes FDA permission to inspect at will.
It also states your full compliance to 21 CFR 312.420. Suggested text from Betterchem…
We (company name) certify that the methods used in, and the facilities and
controls used for the manufacture, processing, packaging and holding of the drug
substances are in conformity with current good manufacturing practice in
accordance with Title 21 of the Code of Federal Regulations, Parts 210 and
211.
We hereby declare that products will be manufactured according to the
methods described in subsequent Type II DMFs. Furthermore, we declare that the
products manufactured by us will conform to the specifications described in
these files. Our facilities will be open to FDA inspection for compliance with
cGMP.
We will advise FDA annually as to the status of this file. In the event
that it is not current, corrective amendments will be submitted. Pursuant to 21
CFR 314.420, if we add, change, or delete any significant information in a file,
we shall notify in writing each person authorized to reference said information.
A list of each person authorized to make reference to this file will also be
submitted to FDA once a year.
"Original Ink Signature"
_____________________________
GENERAL MANAGER
This should be an original document, signed in ink, in all DMFs.
Type 2 DMF Guide
