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GUIDANCE DOCUMENT

ICH Q3C Maintenance Procedures for the Guidance for Industry Q3C Impurities: Residual Solvents July 2017

Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The International Council  on Harmonisation (ICH) has developed maintenance procedures  (PDF - 26KB) for revising the permitted daily exposure (PDE) of solvents included in the Q3C guidance

This web page makes available to the public all recommendations, decisions, and other information related to the revision of the Q3C tables and list (PDF - 183KB).

Final Recommendations for Revision to the List

 


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.