FDA Releases ICH Draft Guideline on Elemental Impurities

• FDA GMP Online Training - respected CGMP online training classes offered by SkillsPlus International Inc.

Updated February 14, 2021

Links broke in the original post.

People also ask about:

ICH HARMONISED GUIDELINE - GUIDELINE FOR ELEMENTAL IMPURITIES - 

Q3D(R1) - ICH Consensus Guideline (PDF)

- - -  original post follows below  - - -

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)

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around