CRED SMPC 2024

17/09/2024

Common Causes of Artwork Error

Error in label content/incorrect annotations

BEST PRACTICES

●

●

Missing change, copy/paste errors, typo in annotations. Can be hard to fix if the error is transposed from the approved content. Inconsistency among strengths/dosage forms ● Sometimes these get missed – especially when not marketed or not yet launched. ●

Review source of change

●

Review across products

●

Review request for change

●

Review final output

●

Feedback loop to Labelling/Regulatory

Getting it RIGHT FIRST TIME is important. Every change you must make – even a single letter – can take days for the graphics house to change, and your change may not be a priority…

Storage conditions/shelf-life

●

Discrepancies between dossiers and what is in manufacturing systems and on artwork.

New Artwork > New Tech Review > New Review/Approval

The Organisation for Professionals in Regulatory Affairs

15

Inspection and Audit Readiness

⚫ Implementation is at the “sharp end” of inspections and audits.

● Common to request proof of meeting implementation timelines: – List of all artworks changed in a period (can be up to 5 years implementation data for safety changes). – List of all batches + information on first batch with new and last batch with old artwork. – List of agreed implementation deadlines for each change. ● Other requests: – List of all release dates. – List of when pack with new artwork arrived in Market.

⚫ Some of this can be VERY hard to find at short notice (particularly where 3 rd party manufacturers are involved). Plan ahead!

The Organisation for Professionals in Regulatory Affairs

16