CRED SMPC 2024

17/09/2024

Typical Contributors

Package Engineering / Artwork Team / Site

Manufacturing / Suppliers / Site QA

Global Labelling / Regulatory Affairs / Local Market ● Provide regulated content ● Specify implementation definition and deadline ● Review and approve the final artwork

Commercial and other stakeholders

● Confirm the change is technically feasible ● Provide technical specification for component ● Liaise with Graphics Specialist to produce artwork file

● Apply change controls to manage components and systems ● Manufacture using new components ● Release and ship

● Ensure

reimbursement

● Confirm price

Stakeholders involved is often determined by the size of the company.

CONSIDER Some markets have other required reviewers/approvers, for example France require Responsible Pharmacist approval

The Organisation for Professionals in Regulatory Affairs

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What’s Going on at the Manufacturer?

⚫ Your label change is just the beginning… – Technical review of change – does it fit on paper/card? Can we print it there? Will it still fit on the line? – Graphics Centre requests/Artwork creation. – Materials management – new component numbers, updating Bill of Materials, component expiry, GTINs. – Finance – component write-off, cost of goods. – Procurement – ordering new components, receiving into warehouse, impact of change. – Quality – incoming inspection on received components, dispensation in systems. – Manufacturing – scheduling to ensure implementation on time, line changes if applicable. – QA/QP Release – new/old components used as specified? Match the authorised presentation? Correct markets?

CONSIDER Some products are only manufactured once a year – so your 6-month implementation might not actually be made until several months after that date!

The Organisation for Professionals in Regulatory Affairs

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