all packaging lines and related operations involving the packing of sterile injectable products, including vials, ampoules, and prefilled syringes in the sterile injection manufacturing department.

3. Responsibilities

• Production Operator: Identify and report discrepancies immediately to the supervisor.
• Packing Supervisor: Verify discrepancies, initiate investigation, and coordinate corrective action.
• Quality Assurance (QA): Evaluate the impact of discrepancies, assist in investigation, and authorize product disposition.
• Quality Control (QC): Support analytical testing if needed during discrepancy resolution.
• Engineering/Maintenance: Investigate mechanical failures contributing to discrepancies.

4. Accountability

The Head of Production is accountable for ensuring the implementation of this SOP and addressing packing line discrepancies in coordination with QA.

5. Procedure

5.1 Identification of Discrepancies

1. Discrepancies may include:
   • Incorrect labeling or missing labels
   • Unsealed or partially sealed units
   • Wrong batch number or expiry date
   • Mixed product batches
   • Incorrect quantity packed
   • Carton damage or missing leaflets
2. Operators must immediately report any observed discrepancy to the supervisor.

5.2 Initial Action

1. The supervisor shall:
   • Stop the line if necessary
   • Quarantine affected units
   • Notify QA for further assessment

5.3 Documentation and Verification

1. Document the discrepancy in the Packing Line Discrepancy Log (Annexure-1).
2. QA will inspect the quarantined units and surrounding area.
3. Conduct reconciliation of labels, cartons, leaflets, and units packed to detect any mismatch.
4. Record details such as product name, batch number, nature of discrepancy, quantity affected, and date/time observed.

5.4 Investigation and Root Cause Analysis

1. QA and Production shall jointly perform a root cause analysis using tools like:
   • Fishbone (Ishikawa) diagram
   • 5 Whys technique
2. If necessary, Engineering shall be involved to assess equipment malfunction.
3. Capture investigation results in the Discrepancy Investigation Report (Annexure-2).

5.5 Corrective and Preventive Action (CAPA)

1. Based on investigation outcome, QA shall recommend CAPA.
2. Implement corrective measures immediately and document them.
3. Preventive actions may include:
   • Operator training
   • Label redesign
   • Equipment calibration or maintenance
4. Record CAPA actions in Annexure-3: CAPA Log.

5.6 Disposition and Line Clearance

1. Only QA may approve product rework, rejection, or release.
2. Line clearance shall be re-performed after resolving the discrepancy before resuming packing.

5.7 Documentation and Record Retention

1. Maintain completed records of discrepancy logs, investigation reports, and CAPA logs.
2. Store documents securely for a minimum of 5 years from batch release date.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• CAPA: Corrective and Preventive Action
• GMP: Good Manufacturing Practice

7. Documents

1. Packing Line Discrepancy Log – Annexure-1
2. Discrepancy Investigation Report – Annexure-2
3. CAPA Log – Annexure-3

8. References

• WHO TRS 986 Annex 2 – GMP Guidelines for Pharmaceutical Products
• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals

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: Packing Line Discrepancy Log

Date	Batch No.	Discrepancy Observed	Quantity Affected	Reported By
22/06/2025	BATCH-1021	Missing label on 5 vials	5	Rajesh Kumar

Annexure-2: Discrepancy Investigation Report

Date	Batch No.	Root Cause	Investigated By	Remarks
23/06/2025	BATCH-1021	Label roll misaligned	Sunita Reddy	Adjusted label sensor

Annexure-3: CAPA Log

CAPA No.	Date	Action Taken	Responsible	Status
CAPA-023	23/06/2025	Operator retraining and sensor alignment	QA & Engineering	Closed

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
20/03/2022	1.0	Initial Issue	New SOP	Head QA
24/06/2025	2.0	Expanded CAPA documentation process	Annual Review	Head QA