FDA will be hosting a public workshop on implementation of the ICH Q3D Guidance for Elemental Impurities on August 22 and 23, 2016. The International Council for Harmonization (ICH) brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. The ICH Q3D Guidance for Elemental Impurities was developed by the ICH to provide a global policy for limiting elemental impurities qualitatively and quantitatively in drug products and ingredients. The purpose of the two-day public workshop is to elaborate key aspects of the ICH Q3D Guidance for Industry on Elemental Impurities in order to facilitate a harmonized interpretation and implementation by industry and regulators. The workshop will include (1) a discussion of how to apply Q3D concepts to routes of administration, not addressed in Q3D, (2) justification for elemental impurity levels higher than an established PDE (3) application of Q3D concepts to determine safe levels of elements not included in Q3D, (4) discussion of the rationale for limits on large volume parenterals, (5) elaboration of the concepts outlined in the Q3D Sections on Risk Assessment and Control of Elemental Impurities and (6) options for converting between PDEs and concentrations.
The workshop will take place on the FDA campus at White Oak and also be broadcast on the web allowing participants to join in person OR via the web. See details below for registration information.
For those participants attending in person there will be food and beverage options available for purchase.
August 22 and 23, 2016
9:00 a.m. to 4:30 p.m.
10903 New Hampshire Avenue
Building 31 Rm 1503 B/C
Silver Spring, MD 20993
- Part 1: https://collaboration.fda.gov/p7ex48kn8wr/
- Part 2: https://collaboration.fda.gov/p52795jh9ll/
- Part 3: https://collaboration.fda.gov/p48s3haiqtr/
- Part 4: https://collaboration.fda.gov/p7yeyw0p3f8/