A revision of the validation guideline ICH Q2(R1) is planned
As announced in summer this year and now in more detail in November, ICH's guideline on validating analytical methods will be revised. The content of this guideline comes from two previously separate guidelines merged in 2005, which were published more than 20 years ago. The decision to revise the validation guideline ICH Q2(R1) was made at the ICH meeting in June, together with the decision to create a new analytical procedure development guideline (ICH Q14). Currently, it is unknown whether these will be two separate documents, or whether a combined guideline will result as a possible combination should be examined by the Expert Working Group.