The Maintenance Procedure is currently applicable only for changes to the Q3C and Q3D Guidelines and M2 Recommendations. In each case the procedure is used when there is new information to be added or the scientific/technical content is out-of-date or no longer valid.

Maintenance Procedure for Q3C Guideline Impurities: Residual Solvents and Q3D Guideline for Elemental Impurities

The Maintenance Procedure for Q3C/Q3D is followed when there is a proposal of a "permitted daily exposure" (PDE) for a new solvent/elemental impurity or a revised PDE for an already classified solvent/elemental impurity. The procedure is similar to the Formal ICH Procedure in that it follows the 5 ICH steps.

Maintenance Procedure for M2 Recommendations

Due to the Information Technology (IT) nature of the M2 EWG's work on Electronic Standards for the Transfer of Regulatory Information (ESTRI), some of their activities result in Recommendations. These Recommendations do not undergo the formal ICH step process, so as to allow for flexible change as both science, and technologies evolve. They are agreed in the EWG, signed by all Members of the EWG, and are approved by the ICH Assembly.

Each new version of the M2 Recommendations is designated by a different version number.