Help! I can't stop looking up nonessential drug manufacturing information!
For ANDAs:http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070124.pdf
• For immediate-release drug products, we recommend that the appropriate USP
method be submitted. If there is no USP method available, we recommend that the
FDA method for the reference listed drug be used. If the USP and/or FDA methods
are not available, we recommend that the dissolution method development report
described above be submitted.
• For modified-release products, dissolution profiles using the appropriate USP method
(if available) can be submitted. If there is no USP method available, we recommend
that the FDA method for the reference listed drug be used. In addition, we
recommend that profiles using at least three other dissolution media (e.g., pH 1.2, 4.5,
and 6.8 buffer) and water be submitted.
This guidance recommends that dissolution data from three batches for both NDAs and ANDAs
be used to set dissolution specifications for modified-release dosage forms, including extendedrelease
dosage forms.
http://www.fda.gov/downloads/Drugs/GuidanceCo...070273.pdf
A. Statutory and Regulatory Requirements
Section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351 (a)(2)(B)) requires drugs, which include IND products, to comply with current good manufacturing practice as follows:
A drug...shall be deemed adulterated...if...the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess.
