Standard Operating Procedure for Equipment Maintenance Log Review in Biosimilar Manufacturing
| Department | Biosimilars |
|---|---|
| SOP No. | SOP/BS/130/2025 |
| Supersedes | SOP/BS/130/2022 |
| Page No. | Page 1 of 11 |
| Issue Date | 04/05/2025 |
| Effective Date | 06/05/2025 |
| Review Date | 04/05/2026 |
1. Purpose
To define the procedure for periodic review and verification of equipment maintenance logs to ensure compliance with preventive maintenance (PM) schedules, traceability, and GMP readiness in biosimilar manufacturing facilities.
2. Scope
This SOP applies to all production and QC equipment including bioreactors, incubators, autoclaves, centrifuges, chromatography skids, and HVAC systems installed within biosimilar manufacturing units.
3. Responsibilities
- Engineering Department: Maintain equipment logs and perform maintenance activities.
- User Departments (Production/QC): Inform engineering of maintenance needs and verify completion status.
- QA: Periodically review maintenance logs and ensure corrective actions are closed before batch release.
4. Accountability
The Head of Engineering is accountable for implementing the preventive maintenance schedule and ensuring that all equipment maintenance is documented and reviewed according to regulatory requirements.
5. Procedure
5.1 Maintenance Log Format and Structure
- Each equipment must have a dedicated logbook or system-generated maintenance file.
- Entries must include:
- Equipment ID and Location
- Date of Activity
- Type of Maintenance (Routine, Breakdown, Calibration)
- Performed By and Checked By
5.2 Review Frequency
- QA shall review equipment maintenance logs on a:
- Monthly Basis – Critical Equipment
- Quarterly Basis – Supportive Equipment
5.3 Review Parameters
- QA shall verify:
- Timely completion of preventive maintenance
- Adherence to equipment calibration schedule
- Closure of breakdowns and deviation reports
- Legibility and completeness of entries
- Record remarks in Annexure-1: Maintenance Review Checklist.
5.4 Deviation and Delay Handling
- Any missed maintenance or overdue activity must be recorded in Annexure-2: Maintenance Deviation Log.
- Engineering shall initiate a Corrective and Preventive Action (CAPA) for repeated delays.
5.5 Archival and Record Retention
- Completed maintenance logs must be archived in the Engineering document control room for 5 years.
- Electronic records must be backed up as per SOP/BS/122/2025 on control system backup.
6. Abbreviations
- PM: Preventive Maintenance
- CAPA: Corrective and Preventive Action
- QA: Quality Assurance
7. Documents
- Maintenance Review Checklist – Annexure-1
- Maintenance Deviation Log – Annexure-2
8. References
- WHO TRS 986 Annex 2 – GMP for Biologics
- EU GMP Chapter 4 – Documentation
- ISPE Baseline Guide: Commissioning and Qualification
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Maintenance Review Checklist
| Equipment ID | Reviewed Date | Reviewed By | Remarks | Status |
|---|---|---|---|---|
| BR-100L | 04/05/2025 | Sunita Reddy | PM done on time | Compliant |
Annexure-2: Maintenance Deviation Log
| Deviation No. | Date | Equipment ID | Description | CAPA Reference |
|---|---|---|---|---|
| DEV-MNT-006 | 02/05/2025 | CHSKID-02 | PM delayed by 5 days | CAPA-0125 |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 04/05/2025 | 2.0 | Added deviation log and electronic record reference | Compliance alignment |