Monday 20 February 2012

Sample Quality Overall Summary

I am sure that, many of you may be interested to take a look at complete NDA/ANDA/Dossier/ASMF. Since, they contain confidential information, no company would like to share it in public domain. But guys! you could check out sample Quality Overall Summary (part of Module-2) of an ANDA submission. FDA has posted samples of Quality overall summary (QOS) in its website the links of which are provided below-

Module 2- It is part of  NDA/ANDA/Dossier/DMF/ASMF, where the summaries of Modules-3,4,5 are presented. It could  be correlated to an abstract of research article or trailer of a movie! The module-2 (Common Technical Document Summaries) consist of the following sections-

2.1 Common Technical Document Table of Contents (Modules 2-5)
2.2 CTD Introduction
2.3 Quality Overall Summary
2.4 Nonclinical Overview
2.5 Clinical Overview
2.6 Nonclinical Written and Tabulated Summaries
  • Pharmacology
  • Pharmacokinetics
  • Toxicology
2.7 Clinical Summary
  • Biopharmaceutic Studies and Associated Analytical Methods
  • Clinical Pharmacology Studies
  • Clinical Efficacy
  • Clinical Safety
  • Literature References
  • Synopses of Individual Studies

 As discussed by me earlier, you need to refer -M4 GuidelineM4Q GuidelineM4S GuidelineM4E Guideline to file a  NDA/ANDA/Dossier/DMF/ASMF in CTD format.

Reference-M4 Guideline

Keywords - Sample Quality Overall Summary, Module-2, M4 Guideline, FDA.


  1. What is the scope of DMF for an API and a Drug product?
    For filing DMF of a drug product, is it must to have the filed DMF of that API?

    1. DMF contains the complete information about drug. In the open part of DMF we can provide specification, certificate of analysis, standard testing procedure, reference product, packing and stability of drug
      whereas in closed part of DMF, we provide the flow chart and procedure and information about raw materials.
      It is necessary to give drugs DMF while filling for product.

      Archana Gawade


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