through proper documentation, communication, and risk assessment.

2. Scope

This SOP applies to all major analytical instruments used in AMD such as HPLC, GC, UV, FTIR, dissolution apparatus, and balances. It includes procedures for reporting breakdowns, logging deviations, initiating service, and managing impacted analysis.

3. Responsibilities

• Analyst: Immediately reports downtime to the Section Head and logs initial observations.
• Section Head: Coordinates service request, reviews impact, and documents alternative arrangements.
• QA Representative: Reviews deviation, verifies CAPA implementation, and closes investigation.
• Engineering/Maintenance: Diagnoses, repairs, and provides instrument service report.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring timely resolution of instrument downtime, regulatory reporting (if applicable), and implementation of preventive controls for future mitigation.

5. Procedure

5.1 Initial Identification and Reporting

1. If an instrument fails to function properly or produces abnormal results (e.g., pressure fluctuations, noise, drift), stop analysis immediately.
2. Record error message, instrument status, and any prior maintenance activities in the Instrument Downtime Log (Annexure-1).
3. Inform the Section Head and mark the instrument as “Out of Service” with appropriate signage.

5.2 Impact Assessment

1. Review pending and ongoing analytical work impacted by the downtime.
2. Assess whether any batch release, stability study, or validation timelines will be affected.
3. If applicable, initiate a deviation report (refer SOP/QA/Deviation/2025) and document the risk to data integrity.

5.3 Corrective Action and Service Request

1. Contact internal engineering team or authorized vendor for immediate troubleshooting and repair.
2. Record all interactions, service visit logs, replaced components, and downtime duration in Annexure-2.
3. Only GMP-qualified personnel may conduct service on regulated instruments.

5.4 Temporary Analytical Arrangements

1. If critical analysis is pending, request QA approval to use alternative validated instruments of the same make/model.
2. Ensure method transfer verification, if applicable, is documented.
3. Record details of interim arrangements in the analytical worksheet and final report.

5.5 Post-Service Qualification

1. Once repaired, perform verification checks as per instrument-specific SOPs (e.g., calibration, system suitability).
2. Conduct performance qualification (PQ) if critical hardware or firmware was replaced.
3. QA must approve requalification before resuming routine use.

5.6 Documentation and Review

1. Ensure all logs, service records, qualification data, and CAPA are attached to the deviation or breakdown file.
2. QA must review and sign off all entries.
3. Trends of recurring issues must be reviewed monthly for preventive maintenance planning.

6. Abbreviations

• HPLC: High Performance Liquid Chromatography
• GC: Gas Chromatography
• QA: Quality Assurance
• CAPA: Corrective and Preventive Action
• PQ: Performance Qualification

7. Documents

1. Annexure-1: Instrument Downtime Log
2. Annexure-2: Instrument Service and Repair Record
3. SOP/QA/Deviation/2025 – Deviation Handling

8. References

• 21 CFR Part 211 – GMP for Finished Pharmaceuticals
• ICH Q9 – Quality Risk Management
• MHRA and WHO Guidelines on Laboratory Equipment Maintenance

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Ritika Sharma	Mayur Desai	Dr. Nidhi Srivastava
Designation	Analyst – AMD	QA Reviewer	Head – Analytical Method Development
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: Instrument Downtime Log

Date	Instrument ID	Description of Issue	Action Taken	Status
30/05/2025	HPLC-002	Detector not responding	Vendor visit, replaced detector lamp	Resolved

Annexure-2: Instrument Service and Repair Record

Instrument ID	Service Date	Engineer Name	Details of Repair	Next Calibration Due
HPLC-002	31/05/2025	Rajesh Patil	Replaced lamp and recalibrated	31/08/2025

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Updated CAPA process and annexures	Annual review	Dr. Nidhi Srivastava
01/06/2022	1.0	Initial release	New SOP	QA Head