ICH Q14 Guideline on Analytical Procedure Development Reaches Step 4

The ICH Q14 guideline on Analytical Procedure Development, developed in parallel with Q2(R2) on Validation of Analytical Procedures, has reached Step 4 and was adopted by the ICH Assembly Regulatory Members. Q14 provides principles for describing the analytical procedure development process, aiming to improve regulatory communication and facilitate more efficient, science- and risk-based approval and post-approval change management of analytical procedures.