including but not limited to HPLC, GC, UV-Vis spectrophotometers, FTIR, KF titrators, and balances.

3. Responsibilities

• QC Analyst: Provide technical input during qualification and operate the instrument post-qualification as per SOP.
• Instrument Coordinator: Coordinate qualification activities and maintain qualification documents.
• Validation Team: Execute qualification protocols and review data.
• QA Officer: Review and approve qualification documentation and ensure regulatory compliance.

4. Accountability

The Head of Quality Control is accountable for ensuring that all new analytical instruments undergo complete qualification before use.

5. Procedure

5.1 Equipment Procurement and Initial Assessment

1. Before procurement, prepare a User Requirement Specification (URS) document detailing:
   • Intended use
   • Performance requirements
   • Data integrity and software compliance
   • Power, space, and utility requirements
2. Vendor proposals must be evaluated against the URS by the QC and QA teams.

5.2 Qualification Phases

The qualification process must consist of the following four key stages:

5.2.1 Design Qualification (DQ)

1. Review the equipment specifications, compliance certificates, and design features.
2. Confirm that the equipment design aligns with URS and applicable GMP standards.
3. DQ shall be documented and approved before procurement.

5.2.2 Installation Qualification (IQ)

1. Verify that the equipment is installed as per manufacturer’s instructions.
2. Checklist for IQ includes:
   • Availability of SOPs and user manuals
   • Verification of model number, serial number
   • Utility connections (power, water, etc.)
   • Environmental conditions
3. Document results in the IQ Protocol (Annexure-1).

5.2.3 Operational Qualification (OQ)

1. Perform functionality checks using calibration standards and reference materials.
2. Verify:
   • System suitability
   • Alarm functions
   • Interlock and safety features
   • Menu navigation and software functionalities
3. Deviation observed during OQ shall be recorded and investigated.
4. Document findings in the OQ Protocol (Annexure-2).

5.2.4 Performance Qualification (PQ)

1. Verify performance using real samples as per actual method conditions.
2. Compare results with validated test methods or standards.
3. Conduct at least three runs with consistent output for reproducibility.
4. Document results in PQ Protocol (Annexure-3).

5.3 Post-Qualification Activities

1. Review all qualification data by QC and QA.
2. Upon approval, assign a unique Equipment ID and affix calibration/qualification tags.
3. Ensure the instrument is included in the calibration and preventive maintenance schedule.
4. Archive all qualification protocols, raw data, and reports in the Equipment Qualification File.

5.4 Requalification Requirements

1. Requalification shall be triggered by:
   • Major maintenance or relocation
   • Change in software/firmware
   • Repeated OOS/OOT linked to the instrument
   • Time-based requalification (e.g., every 3 years)

5.5 Training and Documentation

1. Train all QC users before operating newly qualified instruments.
2. Record training details in the Training Logbook (Annexure-4).
3. Update Instrument Master List and Qualification Tracker.

6. Abbreviations

• URS: User Requirement Specification
• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification
• OOS: Out of Specification
• OOT: Out of Trend

7. Documents

1. Equipment Qualification Protocols (IQ, OQ, PQ)
2. User Requirement Specification (URS)
3. Equipment Master List
4. Qualification Tracker
5. Training Logbook (Annexure-4)

8. References

• ICH Q9 – Quality Risk Management
• 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
• WHO TRS 1019 – Qualification of Analytical Equipment

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: IQ Protocol Checklist

Component	Verification	Result	Remarks
Utility Connection	Verified	Pass	Connected
Equipment Tags	Verified	Pass	As per specs

Annexure-2: OQ Test Parameters

Function	Expected Output	Observed Output	Status
Display Response	Operational	Operational	Pass

Annexure-3: PQ Sample Test Log

Run	Sample ID	Result	Deviation	Status
1	STD001	99.8%	None	Pass

Annexure-4: Training Logbook

Employee	Date	Trainer	Remarks
Sunita Reddy	12/04/2025	Rajesh Kumar	Trained on HPLC Operation

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial version	New qualification SOP	QA Head
14/04/2025	2.0	Included URS and requalification process	System enhancement	QA Head