(PQ) to ensure balance reliability, accuracy, and GMP compliance.

2. Scope

This SOP applies to all new or relocated analytical balances intended for use in the AMD department, and for balances undergoing requalification after maintenance or calibration deviations.

3. Responsibilities

• AMD Analyst: Initiates the qualification protocol and assists in execution.
• Engineering/Maintenance: Performs installation and provides utility confirmation.
• QA Representative: Reviews and approves qualification documents.
• External Vendor (if applicable): Supports traceable calibration and validation services.

4. Accountability

The AMD Manager is accountable for ensuring all balances used in method development are properly qualified, maintained, and documented according to cGMP requirements.

5. Procedure

5.1 Installation Qualification (IQ)

1. Verify physical condition of the balance upon delivery (model, serial number, accessories).
2. Install in vibration-free, draft-protected location with calibrated spirit level.
3. Document environmental conditions such as temperature, humidity, and electromagnetic interference.
4. Check electrical connections, printer ports, and level bubble alignment.
5. Affix ‘Qualified Equipment’ label post verification.

5.2 Operational Qualification (OQ)

1. Ensure internal and external calibration options function as per manufacturer’s instructions.
2. Verify repeatability using standard certified weights (e.g., 10 mg, 100 mg, 1 g, 10 g).
3. Perform eccentricity testing by placing weights at different positions on the pan.
4. Test linearity across the range using certified weights in ascending/descending order.
5. Document readings, tolerance limits, and observations in Annexure-1.

5.3 Performance Qualification (PQ)

1. Evaluate day-to-day accuracy using internal calibration and two external certified weights.
2. Run PQ for three non-consecutive days using same weights by different analysts.
3. Acceptable criteria: % deviation ≤ ±0.1% from standard weight value.
4. Ensure environmental stability during performance checks.

5.4 Post Qualification Steps

1. Compile IQ, OQ, PQ results into a Qualification Summary Report (Annexure-2).
2. Forward the report to QA for review and sign-off.
3. Update Equipment Master List and Calibration Plan Register.
4. Label the balance with “Qualified”, “Calibrated” and “Next Due” stickers.

5.5 Requalification Criteria

• Relocation to another room/facility
• Post-maintenance or software upgrade
• Major deviation in calibration or failed test during routine checks

6. Abbreviations

• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification
• cGMP: Current Good Manufacturing Practice

7. Documents

1. Annexure-1: OQ Data Sheet
2. Annexure-2: Qualification Summary Report
3. Annexure-3: Calibration Certificate (External Vendor)

8. References

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

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Sneha Joshi	Rohit Sharma	Dr. Kavita Mehra
Designation	AMD Analyst	QA Executive	Head – AMD
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: OQ Data Sheet

Weight Used	Nominal Value	Observed Value	% Deviation	Status
Certified Weight 1	10 mg	9.998 mg	-0.02%	Pass
Certified Weight 2	100 mg	100.001 mg	+0.001%	Pass

Annexure-2: Qualification Summary Report

Summarizes IQ, OQ, and PQ completion dates, responsible personnel, observations, deviations (if any), and final approval.

Annexure-3: Calibration Certificate

Provided by NABL-accredited third-party calibration agency with traceability details and validity period.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Added detailed PQ procedure and documentation controls	Annual SOP Review	Dr. Kavita Mehra
01/04/2022	1.0	Initial Release	New SOP	QA Head