IMPLEMENTATION SCHEDULE

• June 2016 : For new marketing authorization

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• December 2017 : For products already marketed

CURRENT REGULATION

The ICH Q3D guideline comes into effect in the three pharmacopeias (Europe, US and Japan).                                                                                                                                                                                                             

	USP -232- ELEMENTAL IMPURITIES LIMITS  USP -233- ELEMENTAL IMPURITIES PROCEDURES
	JP 1.07 "HEAVY METALS LIMIT TEST"
	PH. EUR: 5.20, 2.4.20, 2.4.8

To fullfill ICH Q3D requirements before this deadlines expired, we develop Elemental Impurities Implementation of Risk Assessment Reports, for both API manufacturers and drug product manufacturers. You can contact us regarding a QUOTATION REQUEST for an ICH Q3D report development.