Module 5 Presentations

05/07/2024

Quality Module Headings - Appendices

Common Appendices A.2 -Adventitious Agents A.3 - Novel excipients

Comments • Adventitious agents doesn’t include bacteria, mycoplasma or fungi – discussed appropriate DS/DP modules • Where solvent is simple (e.g. WfI) or marketed then section abbreviated • Novel excipients as 3.2.S of CTD • Viral safety refer to NtA

A.4 -Solvents for reconstitution and diluents

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Common Appendix Questions

• Do you need to include MIA in IMPD? – Part of dossier, not necessary to incorporate as formal appendix • Are CoAs required? – Not mandated, unless product out-of-spec., no CT batch specific CoAs needed. Ref. CoA may be appended (state ref.). If preferred, CoAs may be used in place of batch analysis tables • My product contains no excipients of human or animal origin, do I need a TSE certificate? – No, a declaration in the appropriate sections should be sufficient but this should be clearly stated. If available, include.

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