Module 3 2019

Tests and Acceptance Criteria - Principles

Safety of volunteers and patients is paramount

Tests based on general Regulatory Requirements and Expectations (ICH) and Scientific Rationale Impurities ● Follow ICH Q3 principles for qualification / identification / reporting ● Appropriately tailored (thresholds) for phase of development / duration of study – Acceptance criteria ≤ qualified level

– Level of analytical rigour will increase with time – Reporting thresholds aim at ICH in all phases

ICH (Q6A/B and pharmacopoeias provide guidance on expected attributes

The Organisation for Professionals in Regulatory Affairs