Development and Manufacture of Drug Substances (Chemical and Biotechnological/Biological Entities)
Provides guidance on the application of QbD concepts to the development and manufacture of drug substances, covering selection of starting materials, control of critical quality attributes, and design space for API processes.
Drug substance manufacturers for both small molecule APIs and biological/biotechnological entities. Focuses on the chemistry, manufacturing, and controls (CMC) section of regulatory submissions.
- 01Scientific justification for proposed starting material selection
- 02Identification of CQAs for the drug substance
- 03Development studies establishing critical process parameters
- 04Linkage between development work and commercial manufacturing controls
May 2012. No revisions. Q&A document (2017) clarified starting material requirements.
ICH Q11: frequently asked questions
Quick answers to common questions about ICH Q11.
What is ICH Q11?
ICH Q11 — Development and Manufacture of Drug Substances (Chemical and Biotechnological/Biological Entities) — is a guidance issued by the International Council for Harmonisation. Provides guidance on the application of QbD concepts to the development and manufacture of drug substances, covering selection of starting materials, control of critical quality attributes, and design space for API processes.
Who does ICH Q11 apply to?
Drug substance manufacturers for both small molecule APIs and biological/biotechnological entities. Focuses on the chemistry, manufacturing, and controls (CMC) section of regulatory submissions.
What are the key requirements of ICH Q11?
ICH Q11 requires, among other things: Scientific justification for proposed starting material selection; Identification of CQAs for the drug substance; Development studies establishing critical process parameters; Linkage between development work and commercial manufacturing controls.
When was ICH Q11 last updated?
The current version of ICH Q11 dates from May 2012. May 2012. No revisions. Q&A document (2017) clarified starting material requirements.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When ICH Q11 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.