into secondary packaging such as trays, cartons, and shipper boxes within the sterile packaging area.

3. Responsibilities

• Packing Operator: Execute packaging activities per instructions.
• Packaging Supervisor: Oversee operations, issue materials, and maintain documentation.
• QA Officer: Perform in-process checks and line clearance.

4. Accountability

The Head of Packaging is accountable for ensuring adherence to this SOP and regulatory compliance of all secondary packaging operations.

5. Procedure

5.1 Pre-Packaging Checks

1. Ensure all equipment is cleaned and status labels are updated.
2. Obtain line clearance from QA (Annexure-1).
3. Verify availability of approved batch-specific printed components:
   • Tray Inserts
   • Cartons
   • Labels
   • Shippers

5.2 Tray Loading

1. Place prefilled syringes into designated sterile trays manually or using semi-automatic machines.
2. Check that:
   • Syringes face the correct orientation.
   • No overlap or mechanical damage occurs.
3. Each tray must be labeled with batch number and product name.

5.3 Carton Packing

1. Assemble labeled trays into secondary cartons according to packaging configuration.
2. Include any necessary leaflet, IFU (Instructions for Use), or patient information inserts.
3. Close cartons using tamper-evident sealing tapes.

5.4 Shipper Box Packing

1. Pack the sealed cartons into labeled shipper boxes.
2. Each shipper box must carry external labels including:
   • Product Name
   • Batch Number
   • Quantity
   • Storage Conditions
3. Seal boxes using numbered security tape or strap.

5.5 Reconciliation and Documentation

1. Record quantities of:
   • Prefilled syringes packed
   • Cartons used
   • Shippers dispatched
2. Perform reconciliation of packaging components (Annexure-2).
3. QA to verify reconciliation and sign off.

5.6 Handling of Rejected or Damaged Syringes

1. Segregate any damaged or leaking syringes.
2. Record and destroy under QA supervision (Annexure-3).

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• IFU: Instructions for Use
• GMP: Good Manufacturing Practices

7. Documents

1. Line Clearance Record – Annexure-1
2. Packaging Material Reconciliation Sheet – Annexure-2
3. Damaged Syringe Disposal Log – Annexure-3

8. References

• WHO TRS 986 Annex 6 – GMP for Pharmaceutical Products
• 21 CFR 211 – Current Good Manufacturing Practice
• EU GMP Guidelines – Annex 1

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: Line Clearance Record

Area	Cleared By	Date	Remarks
Secondary Packaging Zone	Sunita Reddy	18/06/2025	Clear

Annexure-2: Packaging Material Reconciliation Sheet

Batch No.	Cartons Issued	Used	Returned	Rejected	Verified By
SYN-PRE-093	5100	5000	90	10	Ravi Nair

Annexure-3: Damaged Syringe Disposal Log

Date	Batch No.	Quantity	Reason	Disposed By
18/06/2025	SYN-PRE-093	15	Cracks in barrel	Ajay Mehra

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
03/03/2022	1.0	Initial SOP	New procedure	Head QA
18/06/2025	2.0	Incorporated reconciliation and damage log	GMP improvement	Head QA