Procedure for Conducting Preventive Maintenance on Validated Equipment
| Department | Engineering/Quality Assurance (QA)/Validation/Production |
|---|---|
| SOP No. | SOP/Ointment/140 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for conducting preventive maintenance on validated equipment used in ointment manufacturing. Proper maintenance ensures continued operational efficiency, reliability, and compliance with regulatory standards.
2. Scope
This SOP applies to all personnel in the Engineering, Quality Assurance (QA), Validation, and Production departments responsible for scheduling, performing, and documenting preventive maintenance activities.
3. Responsibilities
- Engineering Team: Performs scheduled maintenance and repairs.
- QA Officer: Ensures maintenance activities comply with validation requirements.
- Validation Team: Verifies that maintenance does not impact validation status.
- Production Supervisor: Coordinates maintenance schedules with production plans.
- QA Manager: Approves maintenance records and ensures compliance with GMP guidelines.
4. Accountability
The Engineering and QA Managers are accountable for ensuring that preventive maintenance is conducted as per GMP, FDA, ICH, and WHO guidelines.
5. Procedure
5.1 Identification of Equipment for Preventive Maintenance
- Maintain a master list of validated equipment requiring preventive maintenance.
- Classify equipment based on criticality:
- High-Criticality: Mixing tanks, filling machines, HVAC systems.
- Medium-Criticality: Compressors, vacuum pumps, sealing machines.
- Low-Criticality: Storage racks, conveyors, labeling machines.
5.2 Preventive Maintenance Scheduling
- Develop a Preventive
Maintenance (PM) schedule based on:
Ensure PM activities do not disrupt ongoing production.
Assign trained personnel for maintenance execution.
- Manufacturer recommendations
- Equipment usage frequency
- Historical performance data
5.3 Preventive Maintenance Execution
- Ensure the equipment is powered down and secured before maintenance.
- Use only approved tools, lubricants, and spare parts.
- Perform maintenance tasks including:
- Lubrication of moving parts
- Inspection and replacement of worn-out components
- Cleaning and removal of debris
- Calibration of critical sensors and instruments
- Record all activities in the Preventive Maintenance Log.
5.4 Post-Maintenance Validation Check
- QA must verify that maintenance activities did not impact validated parameters.
- Perform a test run to ensure proper functionality.
- Monitor equipment performance for at least one production batch.
5.5 Handling Deviations
- If issues are identified post-maintenance:
- Document deviation details in the Deviation Report.
- Investigate the root cause and implement corrective actions.
- Perform requalification of the affected equipment.
5.6 Documentation and Review
- Maintain maintenance logs, calibration records, and spare parts usage records.
- QA must review and approve all maintenance reports.
- Ensure documentation is available for regulatory audits.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- PM – Preventive Maintenance
- HVAC – Heating, Ventilation, and Air Conditioning
7. Documents
- Preventive Maintenance Schedule (Annexure-1)
- Preventive Maintenance Log (Annexure-2)
8. References
- ICH Q7 – Good Manufacturing Practice Guide
- WHO Guidelines for Equipment Maintenance
- US FDA Guidance on Preventive Maintenance
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Preventive Maintenance Schedule
| Equipment ID | Equipment Type | Frequency | Next Maintenance Due | Assigned Technician |
|---|---|---|---|---|
| MIX-1001 | Mixing Tank | Quarterly | 01/04/2025 | John Doe |
| FILL-2002 | Filling Machine | Monthly | 15/02/2025 | Jane Smith |
Annexure-2: Preventive Maintenance Log
| Date | Equipment ID | Maintenance Performed | Parts Replaced | Technician | Reviewed By |
|---|---|---|---|---|---|
| 01/01/2025 | MIX-1001 | Lubrication, Sensor Calibration | None | John Doe | QA Manager |
| 15/01/2025 | FILL-2002 | Seal Replacement, Belt Adjustment | Sealing Gasket | Jane Smith | QA Manager |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |