Module 3 Presentations

07/05/2024

How are Specifications set? • Considering the safety of study participants (IMPD -> later dossier) • Tests and Acceptance Criteria set considering:  Pre-clinical safety (Tox) data [Impurities]  Bioavailability data [Pharmacokinetics, Dissolution, Particle Size] depends on dosage form  Stability profile of API/product  Other information (e.g. clinical info, process understanding, design space, statistics)  Considering the principles in guidance:  ICH (Q6A [Q6B], Q3A, Q3B, Q3C, Q3D) [Q5A, Q5B, Q5C, Q5D, Q5E]  IMPD guideline. Eudralex Volume 10 Clinical Trials Guidelines  Guidance for Industry (e.g. Biowaiver guidance)

Developing Specifications for the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

7

How are Specifications set?

• Follow ICH Q3 principl es for qualification /identification/reporting • Thresholds should be appropriate for phase of development /duration of the study. • Acceptance criteria ≤ qualified level • Analytical rigour increases over time • Aim at ICH reporting thresholds throughout development

A QRM and PQ Approach

Developing Specifications for the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

8