labeling errors.

2. Scope

This SOP applies to all automated labeling machines used in primary and secondary packaging lines of sterile injectable vials and prefilled syringes at the Sterile Injection Manufacturing facility.

3. Responsibilities

• Machine Operator: Responsible for machine setup, operation, minor adjustments, and in-process checks.
• Packaging Supervisor: Ensures compliance with labeling specifications, machine performance, and coordinates with QA for verification.
• QA Personnel: Verifies label placement, batch details, and documents in-process checks.
• Engineering Department: Handles preventive maintenance and breakdown troubleshooting.

4. Accountability

The Head of Production is accountable for ensuring the proper use and maintenance of automated labeling machines as per GMP and company standards.

5. Procedure

5.1 Pre-Operation Checks

1. Verify machine cleanliness and status using the previous batch cleaning log.
2. Ensure labels are approved by QA and match the batch record.
3. Check label roll for batch number, expiry date, product name, and ensure alignment with artwork.
4. Confirm that the reject mechanism is functional and alarm systems are working.
5. Verify camera system settings for code and label verification.

5.2 Label Roll Loading

1. Load the label roll onto the designated spindle as per the machine’s operational manual.
2. Thread the labels through rollers and apply tension as per the manufacturer’s instructions.
3. Ensure label sensors are active and properly calibrated.
4. Record label roll details in the Label Usage Log (Annexure-1).

5.3 Machine Start-Up and Operation

1. Switch ON the labeling machine and allow it to initialize.
2. Feed a few empty containers (vials/syringes) and verify correct label placement and alignment.
3. Perform an initial in-process check on 5 labeled units with QA verification.
4. Start full operation only after receiving QA clearance.
5. Monitor label presence sensors and reject mechanism regularly during the operation.

5.4 In-Process Verification

1. Every 30 minutes or every 1000 units (whichever is earlier), perform a label inspection:
   • Label content accuracy (product name, strength, batch no., expiry).
   • Placement straightness and adhesion quality.
   • Check label camera system logs for rejections or anomalies.
2. Record findings in the In-Process Label Check Record (Annexure-2).

5.5 Handling Deviations

1. Immediately stop the machine if any mislabeling or system fault is observed.
2. Segregate affected units and inform QA.
3. Record the deviation in the Labeling Deviation Log (Annexure-3).

5.6 Machine Shutdown

1. Stop label application and allow the conveyor belt to run until the last unit is labeled.
2. Remove the label roll and store it securely.
3. Clean machine rollers and sensors using lint-free cloth and IPA 70%.
4. Document cleaning in Annexure-4: Machine Cleaning Log.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• IPA: Isopropyl Alcohol
• GMP: Good Manufacturing Practice

7. Documents

1. Label Usage Log – Annexure-1
2. In-Process Label Check Record – Annexure-2
3. Labeling Deviation Log – Annexure-3
4. Machine Cleaning Log – Annexure-4

8. References

• WHO TRS 986 Annex 2 – GMP for Sterile Products
• EU GMP Guide Annex 1 – Manufacture of Sterile Medicinal Products
• 21 CFR Part 211 – Labeling Requirements

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: Label Usage Log

Date	Batch No.	Product Name	Label Code	Roll Start No.	Roll End No.	Operator
24/06/2025	B12345	Injection A	LBL-2025A	0001	1000	Rajesh Kumar

Annexure-2: In-Process Label Check Record

Time	Sample Size	Parameters Checked	Remarks	Checked By
10:30	5	Content, Alignment	OK	Sunita Reddy

Annexure-3: Labeling Deviation Log

Date	Batch No.	Description of Deviation	Action Taken	QA Reviewed
24/06/2025	B12345	Skewed label placement on 10 vials	Units rejected and re-labeled	Amit Verma

Annexure-4: Machine Cleaning Log

Date	Machine ID	Cleaning Agent	Cleaned By	Checked By
24/06/2025	LBL-03	IPA 70%	Sandeep Patel	QA Executive

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
10/05/2022	1.0	Initial Issue	New SOP	Head QA
24/06/2025	2.0	Updated for digital verification and automated roll tracking	GMP Compliance Update	Head QA