This concludes our discussion on the commonly cited deficiencies for control of the drug product (3.2.P.5) and stability (3.2.P.8).
This is by far the most active area when it comes to deficiencies and comments cited to ANDA applicants. The prevalence of
deficiencies speaks to the criticality of the information with respect to controls proposed for routine release and stability
analysis of the drug product. Applicants should endeavor to provide sound scientific and regulatory justification for all
specifications (tests, methods, and criteria) that are proposed.
As stated in the beginning of the paper, this is not an exhaustive list of deficiencies in the drug product release and stability
sections. However, the authors have attempted to provide the underlying reasons for common deficiencies related to the control
of the drug product during release and stability testing. Our goal is to shed light on the rationale for citing these deficiencies
and demonstrating how pharmaceutical development studies, performed during the initial development of the product, may reduce
the instances of these deficiencies being cited.
* Numbering in section heads correspond to those in the Common Technical Document (CTD).
The authors wish to acknowledge Lawrence Yu, PhD, OGD Deputy Director for Science and Chemistry, for his encouragement and
The views and opinions in this article are only those of the authors and do not necessarily reflect the views or policies
of the FDA.
Aloka Srinivasan, PhD,* is a team leader, Devinder S. Gill, PhD, is a deputy director, and Robert Iser, M.S., is an acting director, at the Office of Generic Drugs within the Office of Pharmaceutical Science, under the US Food and
Drug Administration's Center for Drug Evaluation and Research, Aloka.Srinivasan@fda.hhs.gov
*To whom all correspondence should be addressed.