packaging in the designated packaging hall.

3. Responsibilities

• Packaging Operator: Execute the packaging activities according to instructions.
• Packaging Supervisor: Ensure line setup, batch details, and supervise operations.
• QA Officer: Monitor compliance, perform in-process checks, and approve the line.
• Engineering: Support machine maintenance and breakdowns.

4. Accountability

The Head – Manufacturing is accountable for ensuring the integrity and traceability of secondary packaged gel products.

5. Procedure

5.1 Pre-Packaging Activities

1. Confirm line clearance and environmental condition records are available.
2. Verify availability of printed shippers, inner cartons, inserts, stickers, overwrap films, etc.
3. Cross-check printed packaging materials for batch number, expiry, and barcode.

5.2 Setting Up the Line

1. Set the equipment parameters for carton folding, gluing, or tucking.
2. Load required packaging materials into designated hoppers or rollers.
3. Ensure carton coding system (inkjet/thermal printer) is clean and functional.

5.3 Packaging Operation

1. Insert labeled tubes/jars into inner cartons along with product literature.
2. Close cartons using flap tucking/gluing as per design.
3. Print the required codes (batch no., mfg date, expiry date, MRP) on cartons.
4. Overwrap bundles of cartons if specified in the packaging order.
5. Stack bundles/cartons into outer shippers as per packing instructions.
6. Seal and label shippers with batch details and destination codes.

5.4 In-Process Quality Checks

1. Check printed matter clarity, packaging alignment, and closure integrity.
2. Verify correct quantity per shipper and document reconciliation.
3. Record results in the Packaging IPC Sheet (Annexure-1).

5.5 Post-Packaging Line Clearance

1. Perform reconciliation of all issued packaging materials.
2. Segregate and destroy unused printed components with QA verification.
3. Clean the packaging line and request QA for clearance for next batch.

6. Abbreviations

• IPC: In-Process Control
• QA: Quality Assurance
• GMP: Good Manufacturing Practices

7. Documents

1. Packaging Batch Record
2. Line Clearance Certificate
3. Packaging IPC Sheet – Annexure-1
4. Shipper Label Log

8. References

• Schedule M – Packaging & Labeling Requirements
• WHO GMP Guidelines for Packaging

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Packaging IPC Sheet – Secondary Packaging

Check Point	Frequency	Specification	Results	Initials
Carton Print Clarity	Every 30 mins	Clear and legible
Shipper Label Check	Each shipper	Correct label info
Carton Closure Integrity	Random	No open flaps
Insert Inclusion	Random	Present
Quantity per Shipper	Each shipper	As per BOM

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
03/06/2022	1.0	Initial implementation	New SOP	QA Head
02/06/2025	2.0	Updated with reconciliation and overwrap procedure	Annual Review	QA Head