standards for use in accurate weighing of pharmaceutical materials.

2. Scope

This SOP applies to all new, relocated, or recalibrated analytical balances used in the AMD laboratory for development, validation, and transfer of analytical methods involving precise weighing activities.

3. Responsibilities

• Analyst: Performs the qualification and records observations accurately in the qualification log.
• Engineering/Maintenance: Assists in calibration and environmental setup during installation qualification.
• QA Officer: Reviews qualification reports and ensures GMP compliance.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring that all balances used in method development activities are qualified and maintained as per GMP and regulatory standards.

5. Procedure

5.1 Installation Qualification (IQ)

1. Verify the manufacturer’s documentation including:
   • Instrument manual and specifications
   • Factory calibration certificate
   • Delivery note and warranty card
2. Confirm placement on a vibration-free table, away from air currents and direct sunlight.
3. Check availability of required electrical power supply with earthing.
4. Record environmental conditions (temperature, humidity) at the installation location.

5.2 Operational Qualification (OQ)

1. Switch on the balance and allow it to warm up for a minimum of 30 minutes.
2. Perform internal or external calibration using certified weights (as per manufacturer’s instructions).
3. Perform tests in triplicate for repeatability and accuracy using standard weights:
   • 1 g, 10 g, 20 g, 100 g and 200 g weights with class E2 or F1 tolerance
4. Record displayed weights and calculate the deviation.
5. Acceptable limit: ±0.1% of standard weight or as specified by internal policy.

5.3 Performance Qualification (PQ)

1. Conduct routine checks using internal check weights at the start of each weighing session.
2. Simulate real-time use by weighing placebo materials or excipients typically used in method development.
3. Ensure the balance provides reproducible and consistent results for analytical-grade materials.

5.4 Documentation and Review

1. Record all test results in the Analytical Balance Qualification Form (Annexure-1).
2. Review results against acceptance criteria and document any deviations.
3. Compile final report and submit to QA for review and archival.

5.5 Requalification Triggers

1. Relocation of the balance to a new environment.
2. After major servicing or repair of any internal component.
3. Annually, or as per equipment qualification matrix.

6. Abbreviations

• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification
• QA: Quality Assurance
• AMD: Analytical Method Development

7. Documents

1. Analytical Balance Qualification Form – Annexure-1
2. Calibration Certificate from Manufacturer – Annexure-2

8. References

• USP General Chapter <41> Weights and Balances
• ICH Q9 – Quality Risk Management
• 21 CFR Part 211.68 – Automatic, Mechanical, and Electronic Equipment

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Ravi Mehra	Dr. Sujata Nair	Dr. Harshita Goyal
Designation	Analyst	QA Reviewer	Head – AMD
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: Analytical Balance Qualification Form

Weight (g)	Displayed Weight (g)	Deviation (%)	Pass/Fail
1.000	1.001	+0.10	Pass
10.000	10.002	+0.02	Pass
100.000	99.996	-0.004	Pass

Annexure-2: Manufacturer Calibration Certificate

Includes original calibration certificate with serial number, calibration date, and traceability information to national/international standards.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Added performance qualification section and annexures	Annual Review	Dr. Harshita Goyal
10/06/2022	1.0	Initial release	New SOP	QA Head