jars, covering the use of automatic, semi-automatic, and manual filling machines.

3. Responsibilities

• Filling Machine Operator: Carry out fill weight checks as per frequency defined and record observations.
• Production Chemist: Monitor weight check data, identify trends, and implement corrective action.
• Quality Assurance Officer: Verify fill weight documentation, ensure adherence to tolerance limits, and release batches.

4. Accountability

The Head – Manufacturing is accountable for ensuring implementation and compliance with this SOP.

5. Procedure

5.1 Pre-Filling Checks

1. Ensure weighing balance is calibrated and placed on a vibration-free surface inside the filling area.
2. Verify tare weights of primary packaging components (e.g., empty tubes or jars).
3. Review the product specification sheet for nominal fill weight and allowable limits (e.g., ±5%).

5.2 Weight Checking Frequency

• At the beginning of filling operation – 10 filled units
• Every 30 minutes during filling – 5 filled units
• End of batch – 10 filled units
• After each equipment adjustment or stoppage – 5 filled units

5.3 Weighing and Recording

1. Collect filled gel units as per frequency plan.
2. Weigh each unit on calibrated balance and subtract tare weight to obtain net weight.
3. Compare with nominal weight and document in Fill Weight Monitoring Log (Annexure-1).
4. If weight is out of permissible limits, stop machine, adjust fill volume, and recheck.

5.4 Tolerance Limits

Product Pack Size	Nominal Fill Weight (g)	Tolerance (%)	Acceptable Range (g)
15 g Tube	15	±5%	14.25 – 15.75
30 g Tube	30	±5%	28.50 – 31.50
50 g Jar	50	±5%	47.50 – 52.50

5.5 Corrective Action

• If more than 2 units in a weight check set fail, filling must be stopped and corrective action implemented.
• QA must be notified, and investigation initiated using Deviation Report Form (Annexure-2).
• Suspect units must be segregated, relabeled, or reprocessed depending on batch disposition decision.

5.6 Documentation

• All results must be entered in Fill Weight Monitoring Log with date, time, operator signature, and remarks.
• QA to verify completeness of records during line clearance and batch review.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• BMR: Batch Manufacturing Record

7. Documents

1. Fill Weight Monitoring Log – Annexure-1
2. Deviation Report Form – Annexure-2

8. References

• Schedule M – Good Manufacturing Practices
• Weights & Measures Act – Legal Metrology Compliance

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: Fill Weight Monitoring Log

Date	Batch No.	Product	Time	Unit No.	Gross Wt (g)	Tare (g)	Net Wt (g)	Remarks	Operator Initials
				1
				2

Annexure-2: Deviation Report Form

Batch No.
Date
Filling Line
Observed Weight
Expected Range
Nature of Deviation
Corrective Action Taken
Reviewed By (QA)

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
05/06/2022	1.0	Initial Release	New SOP	QA Head
02/06/2025	2.0	Added weight ranges for multiple formats and updated documentation log format	Regulatory Compliance	QA Head