CRED SMPC 2024

17/09/2024

Managing Artwork “At Risk”

Modern Pharma = Lots of pressure to do things quickly especially for Launch!

Sliding scale of opportunity vs risk (cost!)

APPROVE AT RISK – minimal cost impact but will lose time if need to rework.

PROCURE AT RISK – cost of components PLUS rework/reorder.

PRODUCE AT RISK – cost of finished goods, components, PLUS rework/reorder.

Ensure stakeholder approvals before proceeding.

CONSIDER What is the balance of risk? Routine normally low but also low value. Most pressure comes from Launches.

The Organisation for Professionals in Regulatory Affairs

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Barcodes, 2D Matrices and QR Codes Scanning for Information ● Growing use for structured information on packs. ● 1 1. BARCODE Typically 13 Numbers.

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More and more requests for 2D datamatrix on primary packaging. 2DDM and QR code are considered the main way to link pack to ePIL.

2. 2D DATAMATRIX On EU and many other serialised packs. Requires translation of data contained in there but can contain a lot.

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3. QR CODE Contains just a URL. Becoming more common.

The Organisation for Professionals in Regulatory Affairs

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