FDA Publishes Q&A Document on ICH Q11

May 11, 2018 Suzanne Konigsberg

By: Mustafa A. Zaman, Principal Consultant, PAREXEL Consulting

Recently, FDA published questions and answers guidance ‘’Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological / Biological Entities): Questions and Answers’’.

Essentially, the guideline:

  • Describes the approaches to developing and understanding the manufacturing process of the drug substance (Active Pharmaceutical Ingredient (API);
  • Provides guidance on what information should be provided in Module 3 of the Common Technical Document (CTD), i.e. sections 3.2.S.2.2 – 3.2.S.2.6 (ICH M4Q).
  • It addresses aspects of development and manufacture that pertain to drug substance, including the presence of steps designed to reduce impurities.
  • ICH Q11 provides further clarification on the principles and concepts described in ICH guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10) as they pertain to the development and manufacture of drug substance.

One of the aims of the Q&A is to improve harmonization of the selection and justification of starting materials as well as the information provided in marketing authorization applications and Drug Master Files (DMFs).

Topics addressed in the Q&A include:

  • Clarification of “starting material” Vs. API starting material”, and starting materials for linear and convergent syntheses.
  • Clarification of the selection of starting materials in processes where multiple chemical transformations are run without isolation of intermediates and explains the difference between commercially available chemicals and custom synthesized chemicals.
  • Mutagenic regents and impurities, post-approval changes, and more.

PAREXEL is currently supporting clients in developing regulatory strategies and post-market submissions for a variety small molecule and large molecule products, including drug substance: Manufacturing Process Development, Manufacturing Process Controls, Selection of Starting Materials, Control Strategy, Process Validation/Evaluation and Life Cycle Management.


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