label verification criteria prior to use.

2. Scope

This SOP applies to all visual, dimensional, and quality inspections of printed and unprinted cartons used in packing operations for injectable products within the sterile injection manufacturing facility.

3. Responsibilities

• QA Executive: To perform and document quality inspection of cartons before batch release.
• Packing Operator: To segregate, present, and verify cartons before and during packing operations.
• Warehouse Personnel: To deliver cartons with associated documentation such as approved labels and CoA.
• QC Analyst: To assist in material sampling and testing when required.

4. Accountability

The Head of Quality Assurance is accountable for ensuring compliance with this SOP and release of only inspected and approved cartons for injectable product packing.

5. Procedure

5.1 Receiving and Preliminary Inspection

1. Upon receiving cartons in the packing area, verify that the delivery is accompanied by an approved Certificate of Analysis (Annexure-2) and label artwork.
2. Check for transport damages such as torn cartons, water damage, or misaligned flaps.
3. Ensure batch number, product name, and version code match with the packing order.

5.2 Dimensional and Physical Verification

1. Measure the external dimensions of the cartons (length, width, height) using calibrated vernier calipers or templates.
2. Check GSM (grams per square meter) and ply quality if applicable.
3. Verify slot alignments, scoring depth, and folding strength as per packaging design specifications.
4. Record results in the Carton Inspection Log (Annexure-1).

5.3 Printing and Label Inspection

1. Visually inspect 5 cartons per batch or per 1000 cartons (whichever is greater) for:
   • Clarity of print
   • Proper label placement
   • Correct font and batch data matrix/barcode printing
   • Absence of smudging, misprints, or offset text
2. Perform barcode verification using a barcode scanner.

5.4 Sampling for Testing

1. If needed, send representative carton samples to the QC lab for:
   • GSM verification
   • Compression strength testing
2. Document sampling in the QC Sample Log.

5.5 Label and Artwork Verification

1. Compare the printed label and artwork with the approved version stored in the QA Master File.
2. Ensure the carton batch code and item code match the packing batch.

5.6 Documentation and Approval

1. Fill out the Carton Inspection Log (Annexure-1).
2. Attach supporting CoA and artwork copies (Annexure-2).
3. Submit for QA review and approval via Carton Approval Form (Annexure-3).
4. Approved cartons may be released to the packing area and labeled as “APPROVED.”

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• GSM: Grams per Square Meter
• CoA: Certificate of Analysis

7. Documents

1. Carton Inspection Log – Annexure-1
2. Certificate of Analysis – Annexure-2
3. Carton Approval Form – Annexure-3

8. References

• GMP Guidelines – Schedule M
• ICH Q10 – Pharmaceutical Quality System
• WHO Guidelines on Packaging Material Control

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Carton Inspection Log

Date	Carton Code	Dimensions (mm)	Print Quality	Barcode Status	Inspected By
24/06/2025	CRTN-0201	120x80x30	Acceptable	Verified	Sunita Reddy

Annexure-2: Certificate of Analysis (Cartons)

Carton Code	CRTN-0201
Batch No.	PACK/2025/055
GSM	320
Ply	3
Tested By	Rajesh Kumar
Date	23/06/2025

Annexure-3: Carton Approval Form

Carton Code	CRTN-0201
Inspected By	Sunita Reddy
Reviewed By	Anjali Sharma
Status	Approved
Approval Date	24/06/2025

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
10/03/2022	1.0	Initial Issue	New SOP	QA Head
24/06/2025	2.0	Updated annexures and barcode verification process	Periodic Review	QA Head