function as intended, and perform reliably over time under actual usage conditions.

2. Scope

This procedure applies to all new and existing analytical instruments used in the Analytical Method Development (AMD) laboratory including HPLC, UV spectrophotometers, FTIR, dissolution testers, and balances. It is applicable for both initial qualification and requalification after major maintenance or relocation.

3. Responsibilities

• Engineering/Instrumentation Team: Executes IQ and OQ activities and maintains equipment history.
• Analytical Scientist: Participates in PQ execution and maintains usage logs.
• QA Department: Reviews and approves qualification protocols and reports.
• AMD Head: Ensures compliance with regulatory expectations and internal policies.

4. Accountability

The Head of Analytical Method Development is accountable for the implementation and adherence to this SOP and for ensuring all qualification documentation is complete, accurate, and archived.

5. Procedure

5.1 Installation Qualification (IQ)

1. Verify equipment delivery and cross-check against purchase order and specifications.
2. Ensure location is compliant with environmental conditions (temperature, humidity, power supply).
3. Record equipment details: serial number, make, model, software version.
4. Verify calibration certificates of critical components before installation.
5. Document IQ results in Annexure-1.

5.2 Operational Qualification (OQ)

1. Test each functional component (e.g., pump, detector, sampler in HPLC).
2. Run standard operating sequences to confirm stability and repeatability.
3. Verify safety features and alarm systems.
4. Record OQ parameters in Annexure-2 including pass/fail criteria.

5.3 Performance Qualification (PQ)

1. Conduct actual analytical runs using system suitability standards or previously validated methods.
2. Run multiple replicates to confirm precision and reproducibility.
3. Document observed values, acceptance range, deviations if any.
4. Complete PQ data summary in Annexure-3.

5.4 Qualification Frequency

• Initial Qualification: Upon installation.
• Periodic Requalification: Every 2 years or after significant maintenance/relocation.
• Post-Maintenance: After any repairs affecting critical components (e.g., UV lamp, column oven, detectors).

5.5 Deviation Management

1. Any deviation observed during qualification must be recorded in Deviation Log (Annexure-4).
2. Initiate investigation using 5-Whys or Fishbone method.
3. Implement CAPA and document resolution prior to approval.

5.6 Documentation and Review

1. Compile qualification protocol, raw data, deviation log, and summary report.
2. Submit to QA for review and final approval.
3. Store final documents in equipment history file and master qualification index.

6. Abbreviations

• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification
• HPLC: High-Performance Liquid Chromatography
• QA: Quality Assurance
• CAPA: Corrective and Preventive Action

7. Documents

1. Annexure-1: IQ Checklist
2. Annexure-2: OQ Execution Record
3. Annexure-3: PQ Report Summary
4. Annexure-4: Deviation Log

8. References

• ICH Q9 – Quality Risk Management
• 21 CFR Part 211 – Good Manufacturing Practice for Finished Pharmaceuticals
• WHO Technical Report Series 937, Annex 4 – Qualification of Equipment

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Anjali Mehta	Ramesh Sutar	Dr. Harshita Goyal
Designation	Method Development Chemist	QA Reviewer	Head – AMD
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: Installation Qualification Checklist

Parameter	Specification	Observed	Status
Room Temperature	20–25°C	22.3°C	Pass
Voltage Supply	220V ±10%	218V	Pass

Annexure-2: Operational Qualification Record

Test	Expected Result	Observed Result	Status
Pump Flow Accuracy	1.00 mL/min ±2%	0.99 mL/min	Pass
Detector Wavelength Accuracy	±2 nm	±1.2 nm	Pass

Annexure-3: PQ Summary Report

Performance evaluation of HPLC with USP system suitability mix showed %RSD of 0.89% for peak area, plate count > 2000, and tailing factor within 1.2. Instrument qualified for intended use.

Annexure-4: Deviation Log

Deviation ID	Description	Root Cause	CAPA	Status
DEV-384-01	UV lamp failed during OQ	Expired component	Replaced and requalified	Closed

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Expanded annexures and added CAPA section	Periodic Review	Dr. Harshita Goyal
10/03/2022	1.0	Initial issue of SOP	New Instrument Installation	QA Manager