The Review Process
The first step for CMC review is to check and review the DMF. A letter of authorization must be provided or reviewers will not review the DMF. After verifying the letter of authorization, OGD evaluates proof of structure and synthetic schemes, including the starting material. Then OGD looks at in-process controls and the executed batch records as part of the DMF review. This review is done outside of the ANDA.
DMFs have very different synthetic schemes and manufacturing processes. OGD checks for purity characteristics and stability of the drug substance. They play an important role in drug product manufacturing.
OGD looks for proper validation methods. Without proper validation, the analysis is meaningless. OGD checks for appropriateness of the method and the validation of the method.
