and corrective actions taken.

4) Procedure

4.1 Print Verification Process Overview
4.1.1 Importance of Print Verification
– Print verification ensures that all printed information on labels and inserts is accurate and legible. It is essential to:
– Prevent errors in device identification, labeling, and usage instructions.
– Ensure compliance with regulatory requirements (e.g., FDA, ISO).
– Maintain device traceability through accurate batch and lot numbers, expiration dates, and serial numbers.

4.1.2 Scope of Print Verification
– Print verification covers all printed elements on labels and inserts, including:
– Text: Product name, instructions for use (IFU), warnings, and regulatory statements.
– Graphics and Symbols: Regulatory symbols (e.g., CE mark, sterilization symbol), device images, and safety icons.
– Barcodes/QR Codes: Unique device identifiers (UDIs), lot numbers, and serial numbers.
– Date Codes: Expiry dates, manufacturing dates, and batch/lot numbers.

4.1.3 Frequency of Print Verification
– Print verification should be conducted:
– Before Printing: To check that the artwork and layout meet specifications.
– During Production: At regular intervals during the production run to ensure continuous quality.
– After Printing: To ensure the final print quality and readability of all labels and inserts.

4.2 Pre-Printing Verification
4.2.1 Artwork Approval
– Before any printing takes place, verify that the artwork and design of labels and inserts are correct and have been approved by the relevant departments (e.g., QA, Regulatory Affairs, Packaging).
– Check for Content Accuracy: Ensure that all text, symbols, and images are correct.
– Regulatory Compliance: Ensure that labels and inserts meet regulatory requirements for the market (e.g., FDA, EU MDR).
– Approval Documentation: Ensure that artwork is signed off and documented.

4.2.2 Pre-Printing Sampling
– Perform a sample print test before full-scale production:
– Verify the color, alignment, and layout of the printed materials.
– Ensure that font sizes are legible and consistent with specifications.
– Conduct preliminary barcode scanning to verify that the codes are scannable and meet regulatory standards (e.g., UDI).

4.3 Print Verification During Production
4.3.1 Visual Inspection of Printed Materials
– During the printing process, operators should perform visual inspections to verify that the print quality meets predefined standards. This includes:
– Text Legibility: Ensure that all text is clear and legible without smudging or fading.
– Symbol and Graphic Accuracy: Ensure that regulatory symbols and images are printed clearly and accurately.
– Correct Barcode Printing: Ensure that barcodes or QR codes are readable and properly aligned.

4.3.2 Random Sampling
– At defined intervals, take random samples from the production run and inspect them thoroughly:
– Check for print quality and verify that the labels and inserts match the approved artwork.
– Ensure that no missing or incorrect information is present on any printed material.

4.3.3 Barcode and UDI Scanning
– Use barcode scanners to verify the accuracy and scannability of any printed barcodes or QR codes:
– Scan a sample of barcodes to ensure that they are scannable and that the data matches the corresponding device information.
– Ensure that all batch numbers, serial numbers, and UDI data are correctly encoded.

4.3.4 Monitoring for Print Quality
– Continuously monitor the printing equipment for any issues that may affect print quality:
– Check for ink smudging, fading, or misalignment of printed text.
– Ensure that there are no printing errors such as missing or repeated information.

4.4 Post-Printing Verification
4.4.1 Final Print Inspection
– After printing is completed, conduct a final inspection of all labels and inserts:
– Verify that the final print matches the approved artwork and specifications.
– Confirm that no misprints, missing information, or alignment errors exist.
– Check that all regulatory symbols and text are correctly placed and legible.

4.4.2 Test Barcode and UDI Scanning
– Perform a final scan of all barcodes, QR codes, and UDI labels to ensure that they are scannable and accurate:
– Verify that barcodes correspond to the correct device or lot.
– Test the scannability of labels in various lighting conditions to ensure that they are easily readable by scanning devices.

4.5 Documentation and Record Keeping
4.5.1 Print Verification Records
– Maintain detailed records of all print verification activities, including:
– Results of pre-printing, during production, and post-printing inspections.
– Documentation of any issues found and corrective actions taken.
– Barcode and UDI scanning results, including any failures and rework actions.
– Sampling data, including the number of samples checked and their verification results.

4.5.2 Corrective Actions and CAPA
– If issues are identified during print verification, document the corrective actions taken to address the problems:
– Identify the root cause of printing errors (e.g., equipment malfunction, material defect, human error).
– Implement corrective and preventive actions (CAPA) to address the issue and prevent recurrence.

4.5.3 Record Retention
– Retain print verification records for a minimum of five years or as required by regulatory authorities to ensure traceability and compliance during audits.

4.6 Compliance and Regulatory Requirements
4.6.1 Compliance with Regulatory Standards
– Ensure that print verification activities comply with applicable regulatory standards, including:
– FDA 21 CFR Part 820: Quality System Regulation for medical devices.
– ISO 13485: Medical Device Quality Management Systems.
– EU MDR (Regulation (EU) 2017/745): Medical device regulations for the European market.
– ISO 9001: General Quality Management Systems.

4.6.2 Regulatory Inspections and Audits
– Provide print verification records during regulatory inspections or audits to demonstrate compliance with labeling and packaging requirements:
– Submit records of print verification checks.
– Provide documentation of corrective actions taken for any issues identified during inspections.

5) Abbreviations

– QA: Quality Assurance
– SOP: Standard Operating Procedure
– FDA: Food and Drug Administration
– ISO: International Organization for Standardization
– UDI: Unique Device Identification
– CAPA: Corrective and Preventive Actions

6) Documents

– Print Verification Records
– Barcode and UDI Scanning Logs
– Corrective Action and CAPA Records
– Inspection and Sampling Records

7) Reference

– FDA CFR Title 21, Part 820: Quality System Regulation
– ISO 13485: Medical Devices – Quality Management Systems
– EU MDR (Regulation (EU) 2017/745): General Safety and Performance Requirements
– ISO 9001: Quality Management Systems

8) SOP Version

– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]

Annexure

Annexure 1: Print Verification Checklist Template

Date	Sample ID	Inspection Type	Verification Results	Remarks
DD/MM/YYYY	Label-001	Visual Inspection	Passed	All information is legible

Annexure 2: Barcode Scanning Log Template

Date	Barcode ID	Scanner Used	Scan Result	Operator
DD/MM/YYYY	1234567890	Scanner-01	Pass	Jane Doe