ensures instruments are appropriately installed, operated, and performing as intended before their use in method development or validation, in alignment with GMP and ICH Q10 standards.

2. Scope

This SOP applies to all new, relocated, or upgraded analytical instruments including HPLC, GC, UV-Vis spectrophotometers, dissolution apparatus, pH meters, and balances used in the AMD laboratory for method development and validation purposes.

3. Responsibilities

• Engineering/Service Team: Performs Installation Qualification (IQ) and assists with Operational Qualification (OQ).
• Analytical Scientist/Instrument Owner: Coordinates qualification activities, reviews vendor documents, and executes Performance Qualification (PQ).
• QA: Reviews all qualification documents and ensures release for GMP use.
• Head – AMD: Authorizes instrument use post-qualification and maintains instrument qualification status logs.

4. Accountability

The Head of AMD is accountable for ensuring no unqualified instrument is used for analytical method development or validation studies.

5. Procedure

5.1 Qualification Phases

1. Each instrument must undergo the following:
   • IQ – Installation Qualification
   • OQ – Operational Qualification
   • PQ – Performance Qualification
2. Document each phase using Annexure-1: Instrument Qualification Checklist.

5.2 Installation Qualification (IQ)

1. Ensure proper installation by service personnel as per manufacturer guidelines.
2. Check for:
   • Location conditions (power, humidity, temperature)
   • Instrument part verification (serial numbers, cables, accessories)
   • Software licenses and version control
3. Record results in Annexure-2: IQ Report Template.

5.3 Operational Qualification (OQ)

1. Verify functionality of all critical components, such as:
   • Pumps, detectors, injectors (HPLC)
   • Photometric accuracy (UV-Vis)
   • Flow rate accuracy, column oven performance
2. Perform OQ as per vendor protocols or internal templates.
3. Record results in Annexure-3: OQ Report Template.

5.4 Performance Qualification (PQ)

1. Run test samples, standards, and system suitability solutions to ensure reproducibility and accuracy.
2. Conduct a minimum of three test runs using validated parameters.
3. Ensure compliance with predefined criteria (RSD, retention time, absorbance, etc.).
4. Document using Annexure-4: PQ Report Template.

5.5 Qualification Review and Approval

1. Compile IQ, OQ, PQ documents into a qualification dossier.
2. Submit for QA review and obtain approval using Annexure-5: Instrument Release for Use Form.
3. Label qualified instruments with “Qualified” tag and maintain logbook entry with unique ID.

5.6 Requalification and Change Management

1. Trigger requalification when:
   • Instrument is relocated
   • Major repair or component replacement
   • Regulatory recommendation
2. Partial or full requalification to be conducted based on impact assessment by QA.
3. Log all requalification in the Instrument Master Qualification Register.

6. Abbreviations

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

7. Documents

1. Instrument Qualification Checklist – Annexure-1
2. IQ Report Template – Annexure-2
3. OQ Report Template – Annexure-3
4. PQ Report Template – Annexure-4
5. Instrument Release for Use Form – Annexure-5

8. References

• ICH Q10 – Pharmaceutical Quality System
• WHO TRS 937 – Equipment Qualification Guidelines
• US FDA 21 CFR Part 211 – Subpart D: Equipment
• GAMP 5 – Good Automated Manufacturing Practice

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Instrument Qualification Checklist

Instrument	Type	Make	Model	Required Qualification
HPLC-01	HPLC	Waters	2695	IQ, OQ, PQ

Annexure-2: IQ Report Template

Parameter	Expected	Observed	Status
Electrical Supply	220V	220V	Pass

Annexure-3: OQ Report Template

Component	Test Performed	Result	Status
Pump Flow	1.00 mL/min	1.01 mL/min	Pass

Annexure-4: PQ Report Template

Run No.	Sample	%RSD	RT	Status
1	Standard	0.8%	5.83	Pass

Annexure-5: Instrument Release for Use Form

Instrument ID	Approved By	Date	Remarks
HPLC-01	Sunita Reddy	10/05/2025	Ready for AMD use

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
04/05/2025	2.0	Updated PQ section and requalification triggers	Regulatory audit recommendation