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# ICH Q & A Guideline on Starting Materials Posted
- URL: https://www.fdaweb.com/ich-q-a-guideline-on-starting-materials-posted/
- Published: 2017-02-17T12:00:00.000Z
- Updated: 2026-09-14T22:07:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138013

FDA has posted an International Council for Harmonization guideline on “Q11 Implementation Working Group Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Questions and Answers (regarding the selection and justification of starting materials.” The document was prepared in response to clarification requests on how to implement the ICH Q11 guideline on the development and manufacture of drug substances, particularly the selection and justification of starting materials. It also addresses the information that should be provided in marketing authorization applications and Master Files.