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:
  • Manufacturer recommendations
  • Equipment usage frequency
  • Historical performance data
• Ensure PM activities do not disrupt ongoing production.
• Assign trained personnel for maintenance execution.

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