ICH Q3D(R1) Guideline for Elemental Impurities

Title:
ICH Q3D(R1) Guideline for Elemental Impurities
Short Title:
Q3D(R1)

https://www.gmp-compliance.org/files/guidemgr/Q3D-R1EWG_Document_Step4_Guideline_2019_0322 (4).pdf

Origin/Publisher:

ICH Secretariat, c/o IFPMA, 30 rue de St - Jean, P.O. Box 758, 1211 Geneva 13, Switzerland

Document Type:
ICH Guideline
Content:
This guideline defines requirements for elemental Impurities(element classification and permitted daily exposures)and describes the principles of a risk assessment process.

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