tubes or jars as part of the primary packaging process within the Gel Manufacturing department.

3. Responsibilities

• Production Operator: Operate filling, sealing, and labeling machines as per SOP.
• Line Supervisor: Ensure proper setup and monitoring of the packaging process.
• QA Personnel: Conduct in-process checks and approve packaged units.
• Engineering: Maintain and calibrate packaging equipment.

4. Accountability

The Head – Manufacturing is accountable for adherence to this SOP and the quality of the primary packaged gel products.

5. Procedure

5.1 Pre-Packaging Activities

1. Verify the packaging area is clean and line clearance is approved by QA.
2. Ensure all equipment (filling machine, sealing machine, etc.) is clean and calibrated.
3. Collect the required packaging materials: tubes, jars, caps, labels, etc.
4. Verify packaging materials as per the Bill of Materials (BOM).

5.2 Setting Up the Packaging Line

1. Set the filling volume on the machine based on the approved batch record.
2. Check the nozzle height, product flow rate, and alignment of filling trays.
3. Perform a dummy run using placebo gel to ensure setup accuracy.
4. Ensure clean, sterile spatulas or wipers are available to handle spills.

5.3 Primary Packaging Operation

1. Start filling the gel into tubes/jars using the automatic or semi-automatic machine.
2. Conduct weight verification every 30 minutes or after every 100 units.
3. Seal tubes using the heating element or crimping system.
4. Close jars with caps and apply induction sealing if required.

5.4 Labeling and Coding

1. Ensure labels are printed with batch number, Mfg. Date, Expiry Date, and MRP.
2. Align label rolls in the labeling machine and conduct trial runs.
3. Affix barcode or 2D matrix code as per regulatory requirement.
4. Perform line reconciliation of printed and unprinted labels.

5.5 In-Process Quality Checks

1. Check for fill weight, sealing integrity, label alignment, and legibility.
2. Record all results in the In-Process Control Sheet (Annexure-1).
3. QA to perform random sampling every 1000 units and document results.

5.6 Post-Packaging Activities

1. Perform line clearance after completion of packaging operation.
2. Segregate accepted units for secondary packaging or storage.
3. Send rejected units for investigation and documentation of deviations if any.
4. Ensure reconciliation of all materials used in packaging.

6. Abbreviations

• BOM: Bill of Materials
• QA: Quality Assurance
• GMP: Good Manufacturing Practices

7. Documents

1. Batch Manufacturing Record
2. Line Clearance Record
3. In-Process Control Sheet – Annexure-1
4. Equipment Calibration Log

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice
• WHO TRS 986 – Annex 2: GMP for Pharmaceutical Products

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: In-Process Control Sheet – Primary Packaging

Parameter	Frequency	Acceptance Criteria	Result	Checked By
Fill Weight	Every 30 mins	±5% of target
Seal Integrity	Random	No leakage
Label Placement	Random	Centered, legible
Print Clarity	Every batch	Clear and readable
Barcode Scan	Random	Scannable

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
01/06/2022	1.0	Initial version	New SOP	QA Head
02/06/2025	2.0	Updated annexure and packaging parameters	Review Update	QA Head