Module 5 Presentations

05/07/2024

Overarching IMPD Requirements Guidelines

Biological IMPD • Proteins and

Chemically Defined IMPD • Products produced through

ATMP IMPD • Cell, gene therapy and tissue engineered products • Additional focus on consistency of manufacturing process, traceability, challenges of ATMP inc. medical device

polypeptides and their derivatives, produced from recombinant or non-recombinant

synthetic methods • Includes

cell-culture expression systems. • May also apply

synthesised peptides and oligonucleotides • This guideline is the more extensive of the two – Biologics refers back to it

to other products such as those from tissues

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Quality Module Headings - IMP

DS Module S.1 – General information S.2 – Manufacture S.3 – Characterisation S.4 – Control of DS S.5 – Reference Standards or Materials S.6 – Container Closure System S.7 Stability

DP Module P.1 – Description and Composition of IMP P.2 – Pharmaceutical Development P.3 – Manufacture

P.4 – Control of Excipients P.5 – Control of the IMP P.6 – Reference Standards or Materials P.7 – Container Closure System P.8 Stability

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