nitrogen evaporators used in BA/BE study analysis.

3. Responsibilities

• Instrument User: Ensures PM due dates are tracked, reports issues, and participates during service activities.
• Engineering/Maintenance Staff: Performs or coordinates preventive maintenance as per schedule and logs activities.
• QA Representative: Verifies that PM is completed within schedule and reviews documentation for completeness.

4. Accountability

The Bioanalytical Department Head is accountable for ensuring timely preventive maintenance of all analytical instruments to avoid breakdowns and ensure uninterrupted compliance-driven operations.

5. Procedure

5.1 Maintenance Schedule Preparation

1. Prepare and maintain a Preventive Maintenance Calendar for all instruments in Annexure-1: PM Schedule Tracker.
2. Schedule PM frequency based on:
   • Manufacturer recommendations
   • Instrument usage frequency
   • Criticality to study operations
3. Ensure vendor service contracts are in place for third-party PM where applicable.

5.2 Execution of Preventive Maintenance

1. Perform PM activities on the scheduled date or within ±3 working days.
2. Use equipment-specific maintenance SOPs or vendor checklists for the activity.
3. Ensure the system is in shutdown mode and tagged “Under Maintenance.”
4. Document all tasks in Annexure-2: Preventive Maintenance Log:
   • Instrument ID
   • Date and Time
   • Activity performed (e.g., vacuum pump oil change, filter replacement, calibration)
   • Observations and completion status

5.3 Post-Maintenance Qualification

1. After completion, run system suitability test (SST) or calibration check as applicable.
2. Record SST results in instrument logbook and attach to maintenance record.
3. If SST fails, do not release the instrument until repeat PM or troubleshooting is completed.

5.4 Delayed or Missed Maintenance

1. If PM is delayed beyond scheduled window:
   • Immediately notify QA
   • Document reason in Annexure-3: Deviation Report for PM
   • Do not use the instrument until PM is completed and qualified

5.5 Labeling and Status Update

1. Affix “PM Completed” sticker with:
   • Date of maintenance
   • Next due date
   • Performed by
2. Update PM tracker accordingly.

5.6 Review and Verification

1. QA shall review PM records monthly and ensure no due dates are missed.
2. Audit trail, calibration verification, and checklist completeness will be verified.
3. Corrective action shall be initiated for recurring delays.

6. Abbreviations

• PM: Preventive Maintenance
• LC-MS/MS: Liquid Chromatography–Mass Spectrometry
• SST: System Suitability Test
• QA: Quality Assurance

7. Documents

1. PM Schedule Tracker – Annexure-1
2. Preventive Maintenance Log – Annexure-2
3. Deviation Report for PM – Annexure-3

8. References

• ICH Q10: Pharmaceutical Quality System
• 21 CFR Part 211 – Equipment Maintenance
• Instrument-Specific Maintenance SOPs

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: PM Schedule Tracker

Instrument ID	Instrument Name	PM Due Date	PM Done Date	Status
LCMS-002	Triple Quad MS	10/04/2025	09/04/2025	Completed

Annexure-2: Preventive Maintenance Log

Date	Instrument ID	Activity Performed	Performed By	Remarks
09/04/2025	LCMS-002	Replaced vacuum oil, cleaned ESI source	Sunita Reddy	Stable baseline achieved

Annexure-3: Deviation Report for PM

Instrument ID	Scheduled PM Date	Actual Date	Reason for Delay	Impact on Study	Corrective Action
HPLC-011	05/04/2025	12/04/2025	Service engineer unavailable	Instrument not used during delay	Alternate vendor assigned

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
17/04/2025	2.0	Updated PM tracker, deviation handling, and annexures	Audit Readiness	QA Head