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To provide written instructions for reviewing, editing, and approving finished product dietary supplement labels.
Quality & Regulatory Affairs, Design, and Product Development employees are responsible for following these procedures.
Only label artwork approved by Product Development (PD) and Quality and Regulatory Affairs (QRA) will be used for placing label printing purchase orders.Approved label artwork is achieved through the label artwork review, editing, and approval procedure outlined below, will occur for new label artwork, as well as any existing label artwork requiring any changes made to previously approved versions. PD will begin the process by reviewing the label artwork for the following items:Overall branding and presentation.Product name. Net quantity of contents statement accuracy.Supplement Facts panel declaration accuracy of ingredients, their amounts, and their orders.Ingredient statement declaration accuracy of ingredients, their amounts, and their orders.Major food allergen labeling accuracy. Name and place of business accuracy.Telephone number accuracy.Directions for use accuracy.Spelling and grammar. Revision codes if applicable. If no changes to the label artwork are necessary, the most responsible PD individual approve design and inform the relevant partiesIf changes to the label artwork are necessary, the most responsible PD individual will note clearly what changes need to be made, and then will inform relevant parties that reword is needed
QRA will review the label artwork for the following items with respect to Federal and State labeling regulations, as well as other contractual obligations that must be met:Statement of identity.Net quantity of contents statement compliance.Supplement Facts panel compliance.Ingredient statement compliance. Major food allergen labeling compliance. Name and place of business compliance.Serious adverse event reporting information. Intervening material. Mandatory warning, caution, and notice statements.Structure/function claims disclaimer and symbol use if applicable. Directions for use matching the Serving Size.Trademark and licensing agreement labeling requirements. Type sizes, fonts, and overall layout. Spelling and grammar. All claims and statements made. If no changes to the label artwork are necessary, the most responsible QRA individual approve design and inform the relevant partiesIf changes to the label artwork are necessary, the most responsible QRA individual will note clearly what changes need to be made, and then will inform relevant parties that reword is needed
Once the graphic designer has made all requested changes, the label artwork will route back through this same process until PD and QRA have both approved the labelApproved label artwork will be stored electronically in a designated location, and will include all design files necessary for placing purchase orders for labels.
PURPOSE
RESPONSIBILITY
PROCEDURES
Product Development Review
Quality and Regulatory Affairs Review
Final Approval
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