News about GMP/cGMP

11.10.2019

ICH: ICH Q3C(R6) reinstated with original ethylene glycol PDE

According to the ICH, the PDE value for ethylene glycol was reinstated to its previous PDE value of 6,2 mg/day and a concentration limit of 620 ppm. This value was changed in October 2018 with the ICH Q3C(R7) version  to a PDE of 3.1 mg/day and a concentration limit of 310 ppm. The process was then preceded by an error correction procedure (we reported).

In 2019 the ICH received a request to suspend the error correction for ethylene glycol. Based on archive documents and in-depth literature research, the 2018-decision was reversed by the Expert Working Group. As a consequence, the Q3C(R7) version has now been reverted back to the Q3C(R6) version. Further information can be found here.


Source:

ICH: Newsroom

ICH: Cover statement

EMA: ICH Q3C, Impurities: Guideline for residual solvents 



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