M7(R2) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk: guidance for industry

M7(R2) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk: guidance for industry

Collection:
Health Policy and Services Research
Contributor(s):
Center for Drug Evaluation and Research (U.S.), issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, July 2023
Language(s):
English
Format:
Text
Subject(s):
Carcinogens
Drug Contamination -- prevention & control
Drug Development
Drug Industry
Government Regulation
Mutagenicity Tests
Mutagens
United States
United States. Food and Drug Administration
Genre(s):
Guideline
Technical Report
Abstract:
The synthesis of drug substances involves the use of reactive chemicals, reagents, solvents, catalysts, and other processing aids. As a result of chemical synthesis or subsequent degradation, impurities reside in all drug substances and associated drug products. Although the International Council for Harmonisation (ICH) guidances for industry Q3A Impurities in New Drug Substances (Revision 2) (ICH Q3A) (June 2008) and Q3B(R2) Impurities in New Drug Products (ICH Q3B(R2)) (August 2006) provide guidance for qualification and control for the majority of the impurities, limited guidance is provided for those impurities that are DNA reactive. The purpose of this guidance is to provide a practical framework that is applicable to the identification, categorization, qualification, and control of these mutagenic impurities to limit potential carcinogenic risk. This guidance is intended to complement ICH Q3A, ICH Q3B(R2) (Note 1), and the ICH guidance for industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorizations for Pharmaceuticals (January 2010). This guidance emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in final drug substance or product, taking into consideration the intended conditions of human use. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (ii, 33 pages))
Illustrations:
Illustrations
NLM Unique ID:
9918663780806676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918663780806676