sterile injectable packaging lines, including vial packing, ampoule packing, prefilled syringe lines, and automated or semi-automated systems operated at the facility.

3. Responsibilities

• Packaging Operator: Records line parameters and output in real time.
• Line Supervisor: Reviews and verifies records and ensures any deviations are reported immediately.
• QA Executive: Audits documentation, verifies compliance, and reviews trends for continuous improvement.

4. Accountability

The Head of Production and Head of Quality Assurance are accountable for ensuring the documentation process is implemented and followed as per this SOP.

5. Procedure

5.1 Initiation of Packaging Activity

1. Prior to line startup, ensure that line clearance has been completed and documented as per SOP/SIM/191/2025.
2. Verify availability of approved batch packaging record (BPR) and approved labels.
3. Start the packaging line under supervision, recording the start time and initial observations.

5.2 Real-Time Recording of Performance Parameters

1. Use the Packaging Line Performance Log (Annexure-1) to record the following:
   • Line Start and Stop Times
   • Shifts and Operator Names
   • Machine Speeds and Output per Hour
   • Downtime (with reasons)
   • Rejected Units (categorized by cause)
2. Ensure all entries are made in real-time using indelible ink. Do not leave blank spaces.

5.3 Shift Handover Documentation

1. At the end of each shift, the outgoing operator must brief the incoming operator and sign the handover section in the logbook.
2. Any unresolved issues must be clearly documented and highlighted to the supervisor.

5.4 Recording Deviations and Incidents

1. Any deviations from standard packaging line operations (e.g., frequent rejections, unplanned stoppages) must be recorded in the deviation section of the logbook.
2. QA must be notified immediately for evaluation and impact assessment.
3. Complete a Deviation Form (Annexure-2) if applicable.

5.5 Verification of Line Performance

1. Line Supervisor shall verify the log entries every 4 hours and sign-off on completed pages.
2. QA Executive shall conduct end-of-day review to confirm that data is complete, legible, and compliant.

5.6 Compilation and Archiving

1. At batch completion, line performance data shall be compiled and attached to the BPR.
2. All original logbooks must be retained in QA archives for a minimum of 5 years.

5.7 Training and Review

1. All packaging line personnel shall be trained on this SOP annually.
2. Training records to be maintained as per Annexure-3.

6. Abbreviations

• SOP: Standard Operating Procedure
• BPR: Batch Packaging Record
• QA: Quality Assurance
• GMP: Good Manufacturing Practice

7. Documents

1. Packaging Line Performance Log – Annexure-1
2. Deviation Reporting Form – Annexure-2
3. Training Attendance Record – Annexure-3

8. References

• WHO TRS 986 Annex 2 – GMP for Pharmaceutical Products
• EU GMP Annex 15 – Qualification and Validation
• 21 CFR Part 211 – Current Good Manufacturing Practice

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: Packaging Line Performance Log

Date	Shift	Operator	Output (Units)	Downtime (min)	Remarks
24/06/2025	Morning	Rajesh Kumar	10,000	30	Label roll jammed

Annexure-2: Deviation Reporting Form

Date	Batch No.	Description of Deviation	Immediate Action Taken	QA Comments
24/06/2025	BATCH2025A12	Unexpected stoppage due to sensor failure	Sensor replaced	No impact on product

Annexure-3: Training Attendance Record

Employee Name	Designation	Training Date	Trainer	Signature
Sunita Reddy	Packing Operator	22/06/2025	QA Executive

Revision History:

Revision Date	Revision No.	Revision Details	Reason	Approved By
01/03/2022	1.0	Initial Release	New SOP	QA Head
24/06/2025	2.0	Updated log structure and review frequency	Annual Review	QA Head