Strategies for Returns, Reconciliation and Destruction (WS8)Mark WoolfGal Alterovich

Strategies for Returns, Reconciliation and Destruction• (1) List the elements of IMP reconciliation and

destruction for clinical supplies• (2) Explain how to overcome the challenges of

reconciliation regarding site accountability• (3) Describe the advantages and

disadvantages of local (site/ country) destruction vs centralized destruction

(1) List the elements of IMP reconciliation and destruction for clinical supplies

(1) List the elements of IMP reconciliation and destruction for clinical supplies

Inventory – List of inventory at Sites/Depots/CMO

Roles and ResponsibilitiesOverall ManagementDocumentationDestruction order – client. Authorised person – PM, CRO etc???Certificate of destructionRegulatory – Restrictions / Guidelines

(2) Explain how to overcome the challenges of reconciliation regarding site accountability

(2) Explain how to overcome the challenges of reconciliation regarding site accountability

Documentation requirements- Distinction between IMP, Ancillary, Equipment’s- Used vs unused drug- Regulatory, inventory, internal approvals- Level of accountability box vs kit vs compound or kit elements –syringe, aerosols (by weight?)- Written process – Instructions/Authorizations- Training

- Full circle accountability –return shipments – identifiersdestruction per identifier or site or collectively

- Centralised management and control

(3) Describe the advantages and disadvantages of local (site/ country) destruction vs centralised destruction

(3) Describe the advantages and disadvantages of local (site/ country) destruction vs centralised destruction

Advantages- Control locally of small batches for destruction- Lower cost of destruction locally- Inventory management – at local level- Regulatory compliance locally - By identifier code or batches - Cost ?? By site or by depot vendor and by another party-Approval of the vendor approval of the destruction method- Centralised control and visibility (documentation / audit trail simplicity)- Cost implications

Disadvantages- Regulatory restrictions – Country - (Italy, Serbia, Turkey)status of product and or availability of destruction facilities.

- Transport costs to move zero value product to a central point for destruction.- Considerations – Destruction methods vary from country to country Burial, Incineration, Liquid/Chemical

Thank you