in the Analytical Method Development laboratory. This ensures that all balances meet regulatory requirements and provide accurate and precise weighing results.

2. Scope

This SOP applies to all analytical balances, microbalances, and precision balances used for weighing raw materials, standards, samples, and reagents within the AMD department.

3. Responsibilities

• Analytical Personnel: Perform daily verification before use and document results appropriately.
• Engineering/Calibration Team: Conduct qualification and scheduled calibrations as per plan.
• QA: Review qualification documents and ensure compliance with calibration standards.

4. Accountability

The AMD Head and QA Head are accountable for ensuring that all balances in use are qualified, verified, and calibrated per this SOP and documented accordingly.

5. Procedure

5.1 Installation Qualification (IQ)

1. Ensure the balance is delivered with all accessories and documentation (user manual, calibration certificate, etc.).
2. Install the balance on a vibration-free surface in a designated weighing area with controlled environmental conditions.
3. Record environmental parameters (temperature, humidity, airflow) in Annexure-1.
4. Verify the availability of power supply and leveling of the instrument.

5.2 Operational Qualification (OQ)

1. Use certified standard weights (Class E2 or equivalent) for testing balance performance.
2. Perform accuracy, linearity, and repeatability tests as per Annexure-2.
3. Record observations for each parameter and compare against acceptance criteria.

5.3 Performance Qualification (PQ)

1. Conduct routine usage simulations with weights similar to actual laboratory use conditions.
2. Ensure consistent results for the same weights across multiple replicates.
3. Document PQ results in Annexure-3.

5.4 Daily Verification Procedure

1. Verify zero function and taring before each use.
2. Use standard weights (preferably mid-range of the balance capacity).
3. Document weight verification on Daily Balance Check Log (Annexure-4).
4. Do not use the balance if deviations exceed ±0.1% of the standard weight.

5.5 Calibration and Recalibration

1. Ensure external calibration is performed by a NABL-certified agency as per schedule.
2. Recalibration is triggered in cases of:
   • Balance relocation
   • Deviation or malfunction
   • After preventive maintenance

5.6 Handling Out-of-Tolerance Conditions

1. Stop using the balance immediately.
2. Quarantine and tag the instrument as “Out of Service.”
3. Report to Engineering and QA for investigation.
4. Perform impact assessment of previously weighed materials using the suspect balance.

6. Abbreviations

• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification
• NABL: National Accreditation Board for Testing and Calibration Laboratories

7. Documents

1. IQ Checklist – Annexure-1
2. OQ Test Sheet – Annexure-2
3. PQ Validation Report – Annexure-3
4. Daily Verification Log – Annexure-4

8. References

• USP General Chapter <41> – Balances
• ICH Q9 – Quality Risk Management
• 21 CFR Part 211 – cGMP for Finished Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Kavita Rane	Mohit Raj	Dr. Harshita Goyal
Designation	AMD Analyst	QA Reviewer	Head – AMD
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: IQ Checklist

Parameter	Observation	Complies (Yes/No)
Level surface	Yes	Yes
Temperature control	25°C ±2°C	Yes
Power supply	230V	Yes

Annexure-2: OQ Test Sheet

Weight Used	Nominal Value	Observed Value	% Deviation	Status
Std. Wt 100 mg	100.000 mg	99.987 mg	-0.013%	Pass

Annexure-3: PQ Validation Report

Summary of balance performance with real sample weights during actual laboratory usage simulation across 5 replicates. Data falls within acceptance limits.

Annexure-4: Daily Balance Check Log

Date	Balance ID	Weight Used	Observed Value	Verified By	Status
01/06/2025	BL-202	200 mg	199.995 mg	Kavita Rane	Pass

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Expanded qualification sections and clarified recalibration criteria	Annual review	Dr. Harshita Goyal
10/08/2022	1.0	Initial SOP implementation	New equipment commissioning	QA Head