FDA Perspectives: Common Deficiencies in Abbreviated New Drug Applications: Part 3 - Control of the Drug Product and Stability - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Perspectives: Common Deficiencies in Abbreviated New Drug Applications: Part 3 - Control of the Drug Product and Stability
Chemistry reviewers in the FDA's Office of Generic Drugs provide an overview of common deficiencies cited throughout the CMC section of ANDAs


Pharmaceutical Technology
Volume 35, Issue 2, pp. 58-67

Conclusion

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).

Acknowledgment

The authors wish to acknowledge Lawrence Yu, PhD, OGD Deputy Director for Science and Chemistry, for his encouragement and invaluable insight.

Disclaimer

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,

*To whom all correspondence should be addressed.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
27%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
8%
All of the above.
41%
No government involvement in patient treatment or drug development.
11%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: Pharmaceutical Technology,
Click here