manufactured in the sterile injectable manufacturing facility.

3. Responsibilities

• QC Analyst: Performs weight variation test as per this SOP.
• QA Officer: Ensures compliance to procedure and reviews test data.
• Production Officer: Supports sampling and ensures availability of required containers.

4. Accountability

The Head of Quality Control is accountable for ensuring that weight variation testing is performed and documented as per current GMP and pharmacopoeial guidelines.

5. Procedure

5.1 Sampling

1. Collect 10 containers (vials/ampoules/syringes) randomly from the filled lot as per SOP for in-process sampling.
2. Ensure containers are labeled appropriately and are free from external moisture.

5.2 Equipment Verification

1. Ensure the analytical balance used for weighing is calibrated and within the valid calibration period.
2. Record balance ID and calibration verification before use (Annexure-1).

5.3 Testing Method

1. Weigh each filled container (Gross Weight) and record.
2. Carefully remove the contents completely and clean the empty container.
3. Weigh the empty container (Tare Weight) and calculate Net Weight = Gross Weight – Tare Weight.
4. Record all readings in Annexure-2.

5.4 Acceptance Criteria

1. Refer to applicable pharmacopeia (e.g., USP, IP) for acceptance limits, usually ±10% of label claim.
2. If one or more units are outside acceptable limits, perform investigation as per deviation SOP.

5.5 Documentation and Review

1. All test results must be reviewed and approved by QA.
2. Attach test report to Batch Manufacturing Record for release.

6. Abbreviations

• SOP: Standard Operating Procedure
• QC: Quality Control
• QA: Quality Assurance
• IP: Indian Pharmacopoeia
• USP: United States Pharmacopoeia

7. Documents

1. Balance Calibration Verification Log – Annexure-1
2. Weight Variation Test Record – Annexure-2
3. Deviation Report (if any) – Annexure-3

8. References

• USP <905> Uniformity of Dosage Units
• Schedule M – Good Manufacturing Practices
• WHO TRS No. 986 Annex 2

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: Balance Calibration Verification Log

Date	Balance ID	Calibration Due Date	Checked By
18/06/2025	BAL-003	30/06/2025	Sunita Reddy

Annexure-2: Weight Variation Test Record

Sample No.	Gross Weight (g)	Tare Weight (g)	Net Weight (g)	Remarks
1	5.87	1.42	4.45	Within Limit

Annexure-3: Deviation Report

Date	Deviation Details	Corrective Action	Reviewed By
18/06/2025	Sample 8 out of limit	Batch held, investigation initiated	Anil Jadhav

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Issue	New SOP	QA Head
18/06/2025	2.0	Updated with Annexures and Criteria	Review Cycle	QA Head