PHARMACEUTICAL LABELING COMPLIANCE CHECKLIST

Created by ChecklistGuro (https://checklistguro.com)

--- LABEL CONTENT ACCURACY ---
[ ] Product Name
[ ] Dosage Strength
[ ] Quantity per Package
[ ] Route of Administration (Oral, Intravenous, Topical, Other)
[ ] Directions for Use
[ ] Storage Conditions (Room Temperature, Refrigerated, Controlled Room Temperature)

--- REGULATORY COMPLIANCE ---
[ ] Applicable Regulations (FDA 21 CFR Part 211, EU GMP Guidelines, Other (Specify in Long Text))
[ ] Specify Other Regulations (if applicable)
[ ] Date of Last Regulatory Update Review
[ ] Compliance Status (Compliant, Non-Compliant, Requires Further Assessment)
[ ] Summary of Regulatory Findings (if applicable)
[ ] Supporting Regulatory Documentation

--- MANDATORY STATEMENTS ---
[ ] Product Name Inclusion (Included Correctly, Missing, Incorrect)
[ ] Dosage Strength Confirmation (Correct Dosage Strength, Incorrect Dosage Strength, Missing)
[ ] Lot Number Inclusion (Included Correctly, Missing, Incorrect)
[ ] Expiration Date Inclusion (Included Correctly, Missing, Incorrect)
[ ] Storage Conditions Displayed (Displayed Correctly, Missing, Incorrect)
[ ] Reviewer Signature

--- UNITS OF MEASURE ---
[ ] Primary Unit of Measure (mg, g, mL, L, IU, Count)
[ ] Secondary Unit of Measure (if applicable) (Âµg, ng, kg, kL, None)
[ ] Conversion Factor (if applicable)
[ ] Abbreviation Used
[ ] Is the unit presented as a decimal? (Yes, No)

--- BARCODES & SERIALISATION ---
[ ] Barcode Sequence Number
[ ] Barcode Symbology (e.g., Code 128, DataMatrix)
[ ] Serialisation Data Format
[ ] Serialisation Check Digit
[ ] Barcode Verification Result (Pass/Fail) (Pass, Fail)
[ ] Barcode Image Verification (Optional)

--- LAYOUT & FONT ---
[ ] Font Size (Points)
[ ] Font Type (Arial, Times New Roman, Helvetica, Calibri)
[ ] Font Weight (Normal, Bold, Italic)
[ ] Alignment (Left, Center, Right)
[ ] Line Spacing (Points)
[ ] Text Rotation (None, 90 Degrees, 180 Degrees, 270 Degrees)

--- COLOR & GRAPHICS ---
[ ] Color Accuracy - Visual Comparison (Matches Standard, Slight Variation, Significant Variation)
[ ] Color Measurement - L*a*b* Value (L)
[ ] Color Measurement - L*a*b* Value (a)
[ ] Color Measurement - L*a*b* Value (b)
[ ] Image of Graphic - Front Label
[ ] Image of Graphic - Back Label
[ ] Graphic Reproduction Consistency (Consistent, Minor Variations, Significant Variations)

--- LANGUAGE REQUIREMENTS ---
[ ] Target Market Language(s) (English, French, Spanish, German, Chinese, Japanese, Other (Specify in LONG_TEXT))
[ ] Other Language(s) Specification (if applicable)
[ ] Translated Label Artwork
[ ] Translation Vendor Verification Status (Verified, Pending Verification, Not Applicable)
[ ] Translation Completion Date
[ ] Translator Signature

--- REVIEW AND APPROVAL ---
[ ] Artwork Creation Date
[ ] Artwork Creator (Graphic Designer A, Graphic Designer B, Graphic Designer C)
[ ] Artwork Revision Notes
[ ] Reviewer 1 (Quality) (Reviewer A, Reviewer B, Reviewer C)
[ ] Review Date (Quality)
[ ] Signature (Quality Reviewer)
[ ] Approval Status (Approved, Rejected, Pending Revision)
[ ] Approval Comments (if rejected/pending)

--- MATERIAL & ADHESION ---
[ ] Label Material Type (Paper, Polypropylene, Polyethylene, Vinyl, Other)
[ ] Label Thickness (microns)
[ ] Adhesive Type (Water-based, Hot Melt, Pressure Sensitive, Other)
[ ] Adhesive Coverage (%)
[ ] Adhesion Test Results (e.g., Peel Adhesion, Shear Strength)
[ ] Supporting Documentation (e.g., Material Certificates, Test Reports)

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