reliable weight measurements as per GMP and ICH guidelines.

2. Scope

This SOP applies to all analytical balances used within the Analytical Method Development (AMD) department for sample and standard preparation requiring high precision weighing.

3. Responsibilities

• Analytical Chemist: Performs daily checks, qualification support, and documents readings.
• Engineering/Maintenance: Provides technical support during installation qualification and preventive maintenance.
• QA Personnel: Verifies qualification documents and ensures protocol compliance.

4. Accountability

The Head of AMD is accountable for ensuring that all analytical balances undergo proper qualification and periodic verification in accordance with the approved schedule and regulatory expectations.

5. Procedure

5.1 Qualification Phases

1. Installation Qualification (IQ):
   • Ensure placement on vibration-free surface in a controlled environment.
   • Verify calibration certificates from manufacturer.
   • Connect instrument to stable power source with proper grounding.
2. Operational Qualification (OQ):
   • Test linearity using certified standard weights (e.g., 1 mg to 200 g).
   • Conduct repeatability and drift checks by weighing same mass multiple times.
   • Verify leveling, display resolution, and functionality of tare/zero buttons.
3. Performance Qualification (PQ):
   • Evaluate routine use conditions with typical loads.
   • Verify performance over extended weighing cycles.
   • Include environmental monitoring during PQ (temperature/humidity).

5.2 Daily Performance Verification

1. Verify balance leveling using built-in indicators.
2. Record balance ID, date, time, and weight readings in logbook (Annexure-1).
3. Use certified weights (e.g., 10 mg, 100 mg, 1 g, 10 g) traceable to NABL/NIST standards.
4. Perform weighing in triplicate and document average deviation and % error.

5.3 Acceptance Criteria

1. Repeatability: RSD should be ≤ 0.1% for five consecutive measurements.
2. Accuracy: Weight difference should not exceed ±0.1 mg for weights ≤ 20 g, and ±0.2 mg for weights above 20 g.

5.4 Preventive Maintenance and Re-Qualification

1. Conduct preventive maintenance every 6 months or as per manufacturer guidance.
2. Post-maintenance, perform full OQ and PQ before resuming analytical use.

5.5 Deviation Handling

1. Record any failed results in the deviation log (Annexure-2).
2. Initiate root cause analysis and implement CAPA measures.
3. Do not use the balance until successful re-verification is completed.

6. Abbreviations

• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification
• RSD: Relative Standard Deviation
• CAPA: Corrective and Preventive Action

7. Documents

1. Balance Qualification Protocol – Annexure-1
2. Daily Performance Log – Annexure-2
3. Deviation & CAPA Register – Annexure-3

8. References

• ICH Q2(R1) – Validation of Analytical Procedures
• USP Chapter <41> Weights and Balances
• 21 CFR Part 211 – GMP Requirements
• GAMP5 – Good Automated Manufacturing Practice

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Vikram Joshi	Anita Shah	Dr. Harshita Goyal
Designation	Analyst – AMD	QA Reviewer	Department Head
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: Balance Qualification Protocol

Includes sections for IQ, OQ, and PQ with checklists, observations, and sign-offs.

Annexure-2: Daily Performance Log

Date	Balance ID	Weight Used	Reading 1	Reading 2	Reading 3	Avg	RSD (%)	Status
01/06/2025	BL-102	100 mg	100.003	100.002	100.001	100.002	0.001	Pass

Annexure-3: Deviation & CAPA Register

Logs any failure, deviation number, description, root cause, corrective actions, and final verification status.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Added PQ verification and updated accuracy criteria	Annual Review	Dr. Harshita Goyal
12/08/2022	1.0	Initial SOP Release	New SOP	QA Head