weighing rooms of the sterile injectable manufacturing facility.

3. Responsibilities

• Operator: Responsible for cleaning, using, and documenting weight measurements on balances.
• Production Supervisor: Ensures balances are calibrated and maintained before use.
• QA Officer: Verifies weighing operations and documentation.
• Engineering/Maintenance: Performs periodic preventive maintenance of balances.

4. Accountability

The Head – Production Department is accountable for proper implementation of this SOP.

5. Procedure

5.1 Pre-Use Checks

1. Verify balance calibration status using calibration sticker and certificate.
2. Check bubble level and adjust using leveling screws if needed.
3. Ensure the balance is clean, vibration-free, and placed on a stable surface.
4. Allow the balance to warm up for at least 30 minutes after switching on.

5.2 Daily Performance Check

1. Use certified reference weights (as per Annexure-1) to verify performance.
2. Record verification details in the Balance Verification Log (Annexure-2).
3. If performance is out of tolerance, inform QA and service personnel immediately.

5.3 Weighing of Materials

1. Use appropriate containers/tared vessels for weighing.
2. Press “Tare” before weighing the material to set the balance to zero.
3. Weigh the required quantity and document it in the BMR and weighing log.
4. Avoid overloading; never exceed the balance’s maximum capacity.

5.4 Post-Weighing Activity

1. Clean the balance surface using lint-free cloth and 70% IPA.
2. Record usage in the equipment usage log.
3. Switch off the balance at the end of the shift.

5.5 Precautions

• Do not use the balance if the calibration is expired.
• Avoid weighing materials with high static charges without proper grounding.
• Prevent exposure to drafts and temperature fluctuations during weighing.

6. Abbreviations

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

7. Documents

1. Standard Weight Reference Table – Annexure-1
2. Daily Balance Verification Log – Annexure-2
3. Balance Usage Logbook – Annexure-3

8. References

• USP Chapter 41 – Balances
• 21 CFR Part 211 – GMP for Finished Pharmaceuticals
• Internal Calibration SOP of the organization

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: Standard Weight Reference Table

Weight (g)	Tolerance (± mg)	Material
1 g	0.2	Stainless Steel
10 g	0.3	Stainless Steel
100 g	0.8	Stainless Steel

Annexure-2: Daily Balance Verification Log

Date	Balance ID	Weight Used	Reading	Status	Checked By
18/06/2025	BAL-DISP-01	10 g	9.998 g	Pass	Sachin Patil

Annexure-3: Balance Usage Logbook

Date	Time	Material	Batch No.	Qty Weighed	Operator
18/06/2025	09:10	Sodium Chloride	NC2501	500 g	R. Sharma

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
05/01/2022	1.0	Initial release	New SOP	Head QA
18/06/2025	2.0	Added annexures and clarified balance setup steps	Periodic Review	Head QA