News about GMP/cGMP

07.04.2020

ICH publishes ICH Q3C(R8) with three new PDES for comments

The ICH Q3C(R8) draft Guideline on Impurities: Guideline for Residual Solvents, has reached Step 2b and now enters the consulation period.

The draft document contains solemly the Permitted Daily Exposure (PDE) levels for

  • 2-Methyltetrahydrofuran (proposed is a PDE of 50 mg/day and a placement in Class 3 solvents)
  • Cyclopentyl Methyl Ether (proposed is a PDE of 15 mg/day and a placement in Class 2 solvents)
  • Tertiary Butyl Alcohol (proposed is a PDE of 35 mg/day and a placement in Class 2 solvents).

Further to reaching Step 4, these PDEs would then be integrated into a complete Q3C(R8) Guideline document. The steps are part of a constant maintenance process to enable the revision and inclusion of new PDEs, as new toxicological data for solvents become available.

In addition, a Step 2 Informational Presentation has been developed by the Maintenance Expert Working Group, showing the establishing process of the PDEs for the three solvents.

The deadline for comments is scheduled for 30 July 2020.


Source:

ICH Q3C: Maintenance Website

ICH Q3C(R8) Draft



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