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ICH Q14: Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation

Updated: 14 November 2018

Final concept paper regarding ICH Q14 was issued dated 14 November 2018. It has been proposed that Q2 (R1) must be revised along with development of a new guideline based on development of Analytical Procedure. This can help in harmonization of requirements and improvise the communication amongst regulators and industry. Harmonization is required for several scientific and technical elements involving development of analytical procedure and its submission along with required information in CTD format.

Validation will include maintenance consideration and post-approval verification in the new guideline. Suitable multivariate statistical methods involving sample size and method performance verification will be included in revision. Validation approaches for different analytical procedures will also be incorporated in Q2 (R1) revision. Validation of new analytical processes and statistical aspects related with validation would be included in expanded Q2.

Expert group will comprise of individuals who possess expertise in pharmaceutical control and analytical chemistry. The guideline will include two separate documents for analytical development and analytical validation activities.