immediately, logs preliminary observations.

Instrument Engineer/Technician: Performs diagnostics, initiates repair or escalates to service provider.

QA Officer: Reviews impact assessment, verifies documentation, and approves reprocessing plan if applicable.

Bioanalytical Manager: Oversees root cause analysis, coordinates preventive measures, and ensures continuity of operations.

4. Accountability

The Head of Bioanalytical Department is accountable for ensuring that all equipment malfunctions are resolved efficiently and documented accurately to prevent compromise of study results or regulatory non-compliance.

5. Procedure

5.1 Identification and Immediate Action

1. Upon observing abnormal instrument behavior (e.g., signal loss, peak distortion, temperature drift), the analyst shall:
   • Pause the run (if safe and feasible)
   • Record the time, sample ID affected, and error details in the instrument logbook
   • Inform the department supervisor and QA
2. If autosampler is in use, ensure samples are stored in validated conditions during the interruption.

5.2 Instrument Tagging and Documentation

1. Affix a “BREAKDOWN – DO NOT USE” tag to the instrument with date, time, and analyst initials.
2. Log the incident in the Annexure-1: Equipment Breakdown Register including:
   • Instrument ID and type
   • Date and time of breakdown
   • Error codes/messages if any
   • Description of event

5.3 Diagnostic and Repair Process

1. The designated technician or engineer shall:
   • Review system logs and perform diagnostic routines
   • Document corrective action in Annexure-2: Repair & Maintenance Log
   • Replace or recalibrate affected components
2. If external service is required, raise a service request and record vendor name, visit date, and repair summary.

5.4 Post-Repair Verification

1. Conduct system suitability tests (SST) using approved criteria to verify instrument performance.
2. If SST fails, continue repair and testing until system is restored.
3. Once qualified, remove breakdown tag and resume routine use.

5.5 Impact Assessment

1. QA shall assess the impact of breakdown on:
   • Ongoing runs
   • Sample integrity (e.g., extended storage beyond stability)
   • Calibration standards and QC performance
2. Document results in Annexure-3: Impact Assessment Form.
3. Determine need for sample reinjection or reprocessing; get approvals as necessary.

5.6 Preventive Measures

1. Review breakdown trend quarterly to identify repetitive failure points.
2. Implement preventive maintenance and training schedules to reduce recurrence.

6. Abbreviations

• BA/BE: Bioavailability/Bioequivalence
• LC-MS/MS: Liquid Chromatography–Mass Spectrometry
• SST: System Suitability Test
• QA: Quality Assurance

7. Documents

1. Equipment Breakdown Register – Annexure-1
2. Repair & Maintenance Log – Annexure-2
3. Impact Assessment Form – Annexure-3

8. References

• ICH Q9: Quality Risk Management
• 21 CFR Part 11 – Electronic Records
• Internal Equipment Maintenance SOP

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Equipment Breakdown Register

Instrument ID	Date	Time	Description	Reported By
LCMS-03	15/04/2025	11:20 AM	No signal detected from detector	Rajesh Kumar

Annexure-2: Repair & Maintenance Log

Date	Action Taken	Component Replaced	Performed By	Remarks
15/04/2025	Recalibrated MS source	N/A	Service Engineer	System stable post calibration

Annexure-3: Impact Assessment Form

Run ID	Affected Samples	Storage Time	Stability Confirmed	Reprocessing Required	QA Review
BAE-083	Sample 12–22	48 hrs	Yes	No	Approved

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP Issue	New SOP	QA Head
17/04/2025	2.0	Inclusion of impact assessment and preventive action	Process improvement	QA Head