Artwork Lifecycle Process Management Vilva Natarajan CEO, Karomi
Which Artworks? Labels Cartons PIL Pack Inserts
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Section in the SPL Mock Artwork for Submission
Commercial Artwork
Artwork Lifecycle Formulation Strength Pack Size Mocks Approval Cycle Commercial Artwork 10 mg 50 90 V1 - Brief approval - Dieline approval - Spec. approval Tablet 15 mg 20 mg 120 90 50 V2 V3 Approval by department stakeholders and client Final Approved Digital Artwork For every component - Label - Carton - Insert Formats - Low-res PDF - High-res PDF - AI file
Print Proofs Approved Artwork Print Proof Pre-flight the artwork to check fonts, bleeds, colors, images, etc.
Artwork Lifecycle Formulation Strength Pack Size Mocks Approval Cycle Commercial Artwork Print Proof V1 10 mg 50 90 120 V2 Final Approved Print Proof Shade Card Approval Tablet 15 mg 90 V3 Final Approved Digital Artwork 20 mg 50 Approval by department stakeholders and client For every component - Label - Carton - Insert Printed Material QC
Artwork Revisions Safety related changes NDA Holders Safety related changes requiring updates to Pack Inserts (done through PAS, CBE, AR) ANDA Holders Changes based on RLD
Manufacturing Plant change (own plant, CMO, Site transfers, Lease License) Changes in Marketing, Distribution and Packing company Branding changes (e.g. M&A causing changes in logo) Change in Dieline based on manufacturing process change Artwork Revisions Other reasons
Artwork Lifecycle Formulation Strength Pack Size Mocks Approval Cycle Commercial Artwork Print Proof Tablet 10 mg 15 mg 20 mg 50 90 120 90 50 V1 Artwork Revisions V2 Approval by department stakeholders and client Final Approved Digital Artwork For every component - Label - Carton - Insert Final Approved Print Proof Set Implementation Dates
Country specific Artworks Product launches in different markets may require country specific labeling Compliance to local regulations may require Artwork changes Language requirements in the country may require single or multilingual artworks in local language Artwork revision for country specific artworks may not be in sync with changes being made by the FDA or other market regulations As marketing and distribution companies change in each country, the Artworks keep changing
Artwork Lifecycle Formulation Strength Pack Size Mocks Approval Cycle Commercial Artwork Print Proof Tablet 10 mg 15 mg 50 90 120 90 20 mg 50 V1 Artwork Revisions V2 Approval by department stakeholders and client Final Approved Digital Artwork For every component - Label - Carton - Insert Final Approved Print Proof Country Specific Artwork Approval by department stakeholders and client Final Approved Digital Artwork For every component - Label - Carton - Insert Final Approved Print Proof
Harmonization By understanding the regulatory requirements of different countries, organizations have been able to make a single common label which meets the regulatory requirements of multiple countries or markets. Designing, approving and printing one label as opposed to separate country specific labels is far more efficient and cost effective. Having multiple languages in the same artwork to satisfy different market requirements Thinking about harmonization should start early in the artwork life cycle. Submission labels could be common across multiple markets, but the commercial artwork could be slightly different (e.g. just a License number change) The opposite of Harmonization can also happen, when a single label serving two markets have to be split into two separate labels
Russian and Tajik language in a single Artwork Harmonization
Print Destruction Drug which are no longer in production need to have a Obsoleting date Printed Material stock which are obsolete need to be destroyed so that its not accidently used The stock could be across manufacturing plants and with print vendors The plates and cylinders used to print the artwork are also destroyed if this is the end of life for the artwork.
Summary The Artwork Lifecycle Mock Artworks for Submission Approval cycle for New Commercial Artworks Approval cycle for Artwork Revision Approval cycle for Vendor Proofs Country Specific Artworks Harmonized packs Print Destruction With processes and approvals required at each stage of the Artwork lifecycle, an Artwork Management Software which automates these processes really makes a difference.