The Maintenance Procedure is currently applicable only for changes to the Q3C Guideline Impurities: Residual Solvents 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 In each case the procedure is used when there is new information to be added or the scientific/technical content is out-of-date or no longer valid.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

The Maintenance Procedure for Q3C is followed when there is a proposal of a "permitted daily exposure" (PDE) for a new solvent or a revised PDE for an already classified solvent. The procedure was harmonised by all six parties in Brussels on February 2002 and is similar to the Formal ICH Procedure in that it follows the 5 ICH steps.

Updates to the Addenda of the Q3C guidelines are considered as revisions to the Q3C guideline and are designated by the letter R.

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 parties of the EWG, and are approved and signed off by the ICH Steering Committee.

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