FDA Perspectives: Common Deficiences in Abbreviated New Drug Applications (Part 4) - Pharmaceutical Technology

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FDA Perspectives: Common Deficiences in Abbreviated New Drug Applications (Part 4)
FDA reviewers aim to assist ANDA sponsors in building quality into their submissions by clarifying components of the applications. Part 4 addresses manufacture and container closure.

Pharmaceutical Technology
Volume 35, Issue 4, pp. 62-68


This concludes our discussion on the commonly cited deficiencies in ANDA submissions. To summarize the entire series, ANDA applicants should endeavor to demonstrate product and process understanding; and provide sound scientific and regulatory justification for all information provided and all controls that are proposed in their applications.

As stated throughout, this series is not intended to be an all-inclusive list of deficiencies cited, but only a survey of what types of information are being requested from ANDA applicants, since the implementation of the QbR-QOS format. Throughout the series, the authors have attempted to provide some rationale for citation of common deficiencies. The phrase "pharmaceutical development" has appeared like a refrain in every section of every article. This underlines the importance of adequate pharmaceutical development studies, performed during the initial development of the drug product, which in turn leads to justification for the chosen materials, formulations and processes; and may reduce the instances of such deficiencies being cited.

1 Numbering in section heads correspond to those in the Common Technical Document (CTD).


The authors wish to acknowledge Keith Webber, PhD, Acting Office Director, OGD; Lawrence Yu, PhD, Deputy Director for Science, OGD; and Vilayat A. Sayeed, PhD, Director of Chemistry Division III, OGD, for their input and encouragement as the authors put together this series of articles. We would also like to thank Devinder S. Gill, PhD, Deputy Director of Chemistry Division III, OGD, for his contributions as co-author of Parts 2 and 3 of this series.


The views and opinions in this article are only those of the authors and do not necessarily reflect the views of policies of FDA.

Aloka Srinivasan, PhD,* is a team leader, and Robert Iser, M.S., is an acting director, both 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.


1. A. Srinivasan and R. Iser, Pharma. Technol. 34 (1), 50–59, (2010).

2. A. Srinivasan, R. Iser and D. Gill, Pharma. Technol. 34 (8), 45–51 (2010).

3. A. Srinivasan, R. Iser and D. Gill, Pharma. Technol. 35 (2), 58–67 (2011).

4. FDA, QbR Frequently Asked Questions (June 4, 2007).

5. USP 33–NF 28 (US Pharmacopeial Convention, Rockville, MD, 2011).

6. FDA OGD, Residual Solvents in ANDAs: Questions and Answers (Rockville, MD, Oct. 28, 2008), http://www.fda.gov/downloads/AboutFDA/CentersOffices/CenterforDrugEvaluationandResearch/ucm119607.pdf.

7. FDA, Draft Guidance for Industry: Size of Beads in Drug Products Labeled for Sprinkle (Rockville, MD, January 2011).

8. FDA, Guidance to Industry: Container Closure Systems for Packaging Human Drugs and Biologics (Rockville, MD, May 1999).

9. FDA, "21 CFR 176 Indirect Food Additives: Paper Board and Paperboard Components through 21 CFR 186 Indirect Food Additives Affirmed as Generally recognized as safe (Rockville MD, Apr. 1, 2010).

10. ICH, Q3B, Impurities in New Drug Products (R2) (Geneva, July 2006)

11. FDA, OGD, Guidance for Industry: ANDAs: Impurities in Drug Products ((Rockville, MD, November 2010).

This article represents the views of the authors and not of FDA.


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