FDA Releases ICH Draft Guideline on Elemental Impurities

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Updated February 14, 2021

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ICH HARMONISED GUIDELINE - GUIDELINE FOR ELEMENTAL IMPURITIES - 

Q3D(R1) - ICH Consensus Guideline (PDF)

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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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ICH Increases Transparency - Publishes Its New Procedures Manual

ICH Looks to Increase Transparency of its Activities, Processes with New Procedures Manual:

"The International Conference on Harmonisation (ICH), a pharmaceutical regulatory harmonization body consisting of regulators from the US, EU and Japan, is publishing new documents intended to explain in full detail exactly what goes on within its regulatory black box."

For your reference:
ICH Procedures (PDF)

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FDA Adopts ICH Q11 (Development & Manufacture of Drug Substances)

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The Food and Drug Administration (FDA) posted a guidance entitled “Q11 Development and Manufacture of Drug Substances.” The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes approaches to developing and understanding the manufacturing process of a drug substance and provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both chemical entities and biotechnological/biological entities). The discussion of principles in the guidance is intended to apply only to the manufacture of drug substance, not the manufacture of finished drug products.

Related Links:

• FDA Guidance for Industry - Q11 Development and Manufacture of Drug Substances (PDF)
• ICH Q11 - Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological Biological Entities)  (this links navigates to a page containing Q11-related documents)

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