requirements such as GMP, ICH, and 21 CFR Part 11.

2. Scope

This procedure is applicable to all new and existing analytical instruments in the Analytical Method Development (AMD) department, including but not limited to HPLC, GC, UV-Vis spectrophotometers, FTIR, and dissolution apparatus.

3. Responsibilities

• Instrument Owner: Coordinates qualification activities and maintains records.
• QA Representative: Verifies and approves qualification documentation.
• Vendor/Engineer: Provides qualification support and installation verification.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring timely and compliant qualification of all relevant analytical instruments and for ensuring continued compliance post-qualification.

5. Procedure

5.1 Qualification Lifecycle

The qualification lifecycle comprises the following stages:

1. Installation Qualification (IQ)
2. Operational Qualification (OQ)
3. Performance Qualification (PQ)

5.2 Installation Qualification (IQ)

1. Verify installation location against layout plan and environmental specifications.
2. Check utilities availability: electrical, gas, water, and ventilation where applicable.
3. Confirm physical inspection of all components as per delivery checklist.
4. Ensure calibration certificates and user manuals are supplied by the vendor.
5. Record serial numbers, part codes, and software versions in the IQ report (Annexure-1).

5.3 Operational Qualification (OQ)

1. Perform functional testing of hardware modules (e.g., lamp, pump, injector).
2. Conduct system checks including signal response, wavelength accuracy, and interface testing.
3. Verify software access controls and 21 CFR Part 11 compliance features, if applicable.
4. Document OQ results in standard template (Annexure-2).

5.4 Performance Qualification (PQ)

1. Execute test runs using standard reference substances.
2. Evaluate system suitability parameters (e.g., retention time, resolution, tailing factor).
3. Establish that results are within acceptance criteria over three independent runs.
4. Record results in PQ template (Annexure-3).

5.5 Requalification

Requalification is required in the following scenarios:

• Major hardware or software changes
• Relocation of equipment
• After extended periods of inactivity (e.g., > 3 months)
• Post-maintenance or repair activities

5.6 Change Control

1. Initiate change control document for requalification events.
2. Update qualification status labels and logs accordingly.

5.7 Documentation and Record Keeping

1. Ensure that IQ/OQ/PQ reports are complete, reviewed, and approved.
2. Maintain copies in the instrument qualification file and digital archive.
3. Label instrument with qualification status and validity date.

6. Abbreviations

• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification
• AMD: Analytical Method Development
• GMP: Good Manufacturing Practice

7. Documents

1. IQ Report Template – Annexure-1
2. OQ Report Template – Annexure-2
3. PQ Report Template – Annexure-3
4. Change Control Form – Annexure-4

8. References

• ICH Q9 – Quality Risk Management
• WHO Technical Report Series 937
• 21 CFR Part 11 – Electronic Records and Signatures

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Alok Shah	Priya Nair	Dr. Harshita Goyal
Designation	Analytical Chemist	QA Reviewer	Head – Analytical Method Development
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: IQ Report Template

Captures equipment ID, serial numbers, installation site conditions, and component verification checklist.

Annexure-2: OQ Report Template

Includes functionality checklists for subsystems, operational verification outcomes, and deviation logs.

Annexure-3: PQ Report Template

Compares actual performance to predefined criteria using standard samples and test methods.

Annexure-4: Change Control Form

Change ID	Reason for Change	Qualification Impact	Status
CHG-312-01	Instrument relocation to new lab	PQ requalification required	Open

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Updated IQ/OQ/PQ templates and added Change Control Annexure	Annual SOP Review	Dr. Harshita Goyal
10/03/2022	1.0	Initial Release	New SOP	QA Head