Somatic Cell Therapy Medicinal Products – Pharmacy Institutional Readiness Guidance

Somatic cell therapy medicinal products use cells or tissues as starting materials.  They are classed as ATMPs and Pharmacy oversight is required even when they are handled by another department within the Healthcare organisation.

The purpose of this document is to outline the key areas where Chief Pharmacists should focus pharmaceutical expertise prior to an organisation implementing any Somatic Cell Therapy Medicinal Product (sCTMP).

This document presents a flow diagram outlining a stepwise approach to implementing processes to prepare and administer sCTMPs. It is followed by checklists which relate to the various steps presented in the diagram.