Q3E Guideline for Extractables and Leachables; Draft Guidance
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- Title
- Q3E Guideline for Extractables and Leachables; Draft Guidance
- Posted
- Dec 1, 2025
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- Jun 12, 2026Comment from Amarjit LuniwalSupportOther
The commenter, likely a representative of a pharmaceutical or medical device company (implied by the technical focus on "sponsors" and "combination products"), argues that the draft guidance lacks a clear definition for "semi-permeable" packaging. They recommend establishing quantitative thresholds and clarifying the scope of the term to ensure consistency in extractables and leachables testing.
Read comment → - May 26, 2026Comment from Wenan LuOtherIndividual
The commenter is seeking technical clarification regarding the calculation of the Area Effect Threshold (AET) for filters in specific manufacturing configurations. They are asking whether the dilution factor should be based on the buffer tank volume or the total batch volume when a filter is positioned before a buffer tank that feeds multiple filling lines.
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