Saturday, October 19, 2013

FDA Releases ICH Draft Guideline on Elemental Impurities

US FDA Releases ICH Draft Guideline on Elemental Impurities - Outsourcing-Pharma.com:

"The guideline consists of three components: the evaluation of the toxicity data for potential elemental impurities, the establishment of a Permitted Daily Exposure (PDE) for each element of toxicological concern, and development of controls designed to limit the inclusion of elemental impurities in drug products to levels at or below the PDE."

Follow this link to the guidance:  INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE - DRAFT CONSENSUS GUIDELINE - GUIDELINE FOR ELEMENTAL IMPURITIES - Q3D (pdf)

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