FDA announced the availability of the guidance “Q11″

· TGI - Regulatory

Q11 Guidance describes


  • approaches to developing and understanding the manufacturing process of the drug substance,
  • guidance on what information should be provided in Module 3 of the Common Technical Document (CTD) sections 3.2.S.2.2 – 3.2.S.2.6 (see the ICH guidance M4Q: The CTD – Quality3 (ICH M4Q)).
  • aspects of development and manufacture that pertain to drug substance, including the presence of steps designed to reduce impurities
  • provides further clarification on the principles and concepts described in the ICH guidances, Q8 Pharmaceutical Development (ICH Q8), Q9 Quality Risk Management (ICH Q9), and Q10 Pharmaceutical Quality System (ICH Q10), as they pertain to the development and manufacture of drug substance.



CTD Pyramid

CTD Pyramid (Photo credit: Wikipedia)




This guidance is applicable to drug substances as defined in the Scope sections of the ICH guidances, Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (ICH Q6A) and Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (ICH Q6B), but might also be appropriate for other types of products following consultation with the appropriate regulatory authorities. It is particularly relevant to the preparation and organization of the contents of sections 3.2.S.2.2 – 3.2.S.2.6 of Module 3 of the Common Technical Document (ICH M4Q). The guidance does not apply to contents of submissions during the clinical research stages of drug development. Nevertheless, the development principles presented in this guidance are important to consider during the investigational stages.


Regional requirements for postapproval changes are not covered by this guidance.


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