CRED Getting the CMC Dossier Right 2024

28/08/2024

ICH Specific Tests: Parenteral (2)

• Water content: • For non-aqueous parenteral, and for parenteral products for reconstitution, when appropriate • Antimicrobial preservative content • If preservative present • Antioxidant preservative content • At release test • Stability data to confirm the need for such test at expiry • Extractables • If needed, acceptance criteria for extractables from the container/closure components are considered appropriate for parenteral products packaged in non-glass systems or in glass containers with elastomeric closures

The Organisation for Professionals in Regulatory Affairs

35

ICH Specific Tests: Parenteral (3)

• Functionality testing of delivery systems • E.g. pre-filled syringes, autoinjector cartridges, or equivalent - test procedures and acceptance criteria related to the functionality of the delivery system

Osmolarity •

•

If tonicity is declared in the labelling

Particle size distribution •

•

May be appropriate for injectable suspensions. • Acceptance criteria should take into consideration potential for particle growth during storage • Redispersibility

Reconstitution time •

•

Diluent should be justified

The Organisation for Professionals in Regulatory Affairs

36

18