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GUIDANCE DOCUMENT

Q3C Maintenance Procedures July 2017

Download the Final Guidance Document
Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This Maintenance Procedure has been developed by the International Council for Harmonisation (ICH) for revising the existing ICH guidance for industry Q3C Impurities: Residual Solvents (ICH Q3C) to include new solvents and revising existing permitted daily exposures (PDEs) for solvents already listed in ICH Q3C as new toxicity data for solvents becomes available.

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.

 
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