at the Gel Manufacturing department.

3. Responsibilities

• Production Operator: Responsible for sampling and weighing of filled units.
• QA Analyst: Responsible for verifying the accuracy and maintaining records.
• Head – Manufacturing: Accountable for ensuring procedural adherence.

4. Accountability

QA department shall be accountable for ensuring all results are documented and deviations investigated, if applicable.

5. Procedure

5.1 Sampling

• Select 10 samples randomly from each packaging batch.
• Ensure that samples are collected after the filling machine has stabilized.

5.2 Equipment and Materials

• Analytical balance (calibrated)
• Weighing boats or trays
• Scissors for emptying content (if needed)
• Weight Variation Logbook (Annexure-1)

5.3 Procedure

1. Weigh the filled container (gross weight) and record.
2. Empty the entire content of the container and weigh the empty container (tare weight).
3. Calculate the net weight: Gross weight – Tare weight.
4. Record all weights in the logbook.
5. Compare with the labeled claim and permissible limits (±5% unless otherwise specified).

5.4 Acceptance Criteria

• Minimum 9 out of 10 units must comply with the ±5% limit.
• None of the samples should exceed ±10% variation.

5.5 Rejection Criteria

• More than one sample deviating beyond ±5%.
• Any sample showing deviation beyond ±10%.

5.6 Actions on Failure

• Hold the batch and initiate deviation form (Annexure-2).
• Investigate potential root cause (filler calibration, operator error, tube malfunction, etc.).
• Rework batch if feasible and authorized by QA.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• GMP: Good Manufacturing Practice

7. Documents

1. Weight Variation Logbook – Annexure-1
2. Deviation Report – Annexure-2

8. References

• WHO TRS 986, Annex 2 – GMP for Pharmaceutical Products
• In-house product specification file

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: Weight Variation Logbook Format

Batch No.
Product Name
Date
Sample No.	Gross Weight (g)	Tare Weight (g)	Net Weight (g)	Labeled Claim (g)	Deviation (%)	Result
1						[ ] Pass [ ] Fail

Annexure-2: Deviation Report Format

Deviation ID
Date of Detection
Product Name
Batch Number
Nature of Deviation
Investigated By
Root Cause
Corrective Action
Approved By

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
15/06/2022	1.0	Initial version	New SOP	QA Head
02/06/2025	2.0	Updated rejection criteria and added annexures	Periodic Review	QA Head