1.0 OBJECTIVE:

1.1 This SOP shall describe the requirements and procedures for planning, execution, documentation, and control of preventive maintenance activities for equipment, instruments, utilities, and facility systems to ensure reliable operation, prevention of breakdowns, and compliance with GMP requirements.

2.0 SCOPE:

2.1 This SOP shall be applicable to all equipment, instruments, utilities, and facility systems installed in:

2.1.1 Production Areas
2.1.2 Packing Areas
2.1.3 Warehouse Areas
2.1.4 Quality Control Laboratory
2.1.5 Utility Areas
2.1.6 HVAC Systems
2.1.7 Water Systems
2.1.8 Engineering and Support Systems

3.0 RESPONSIBILITIES:

3.1 Engineering Department shall prepare and implement the preventive maintenance schedule.

3.2 Engineering Personnel shall perform preventive maintenance activities as per approved procedures and schedules.

3.3 User Department shall coordinate equipment availability for maintenance activities.

3.4 Quality Assurance (QA) Department shall review maintenance records wherever applicable and assess impact on product quality.

3.5 Engineering Head shall ensure timely completion and review of preventive maintenance activities.

4.0 DEFINATIONS:

4.1 Preventive Maintenance (PM):
Preventive Maintenance is a planned and documented maintenance activity performed at predetermined intervals to minimize equipment breakdowns and ensure consistent operational performance.

4.2 Breakdown Maintenance:
Maintenance activity carried out after failure or malfunction of equipment or system.

4.3 Calibration:
A documented activity performed to establish the accuracy of an instrument by comparison with a recognized standard.

4.4 Maintenance Schedule:
A predefined plan indicating frequency and activities required for preventive maintenance of equipment and systems.

5.0 PROCEDURE:

5.1 Preparation of Preventive Maintenance Schedule:

5.1.1 Engineering Department shall prepare an annual preventive maintenance schedule for all applicable equipment and systems.

5.1.2 Preventive maintenance frequency shall be defined based on:
5.1.2.1 Manufacturer recommendations
5.1.2.2 Equipment criticality
5.1.2.3 Equipment usage history
5.1.2.4 Breakdown trend analysis
5.1.2.5 Regulatory and GMP requirements

5.1.3 The preventive maintenance schedule shall include:
5.1.3.1 Equipment name
5.1.3.2 Equipment ID number
5.1.3.3 Location
5.1.3.4 Frequency of maintenance
5.1.3.5 Planned maintenance date

5.1.4 Approved preventive maintenance schedules shall be communicated to concerned departments.

5.2 Execution of Preventive Maintenance:

5.2.1 Preventive maintenance activities shall be performed as per approved schedule.

5.2.2 Equipment shall be cleaned before commencement of maintenance activities wherever applicable.

5.2.3 “UNDER MAINTENANCE” status label shall be affixed on equipment during maintenance activity.

5.2.4 Preventive maintenance activities may include:
5.2.4.1 Cleaning
5.2.4.2 Lubrication
5.2.4.3 Inspection of components
5.2.4.4 Tightening of parts
5.2.4.5 Replacement of worn-out components
5.2.4.6 Functional checks
5.2.4.7 Safety checks

5.2.5 Only trained and authorized personnel shall perform maintenance activities.

5.2.6 Appropriate tools and calibrated measuring devices shall be used during maintenance activities.

5.3 Maintenance of Critical Equipment:

5.3.1 Special attention shall be given to critical GMP equipment and utility systems.

5.3.2 Maintenance activities affecting product quality shall be assessed for impact by QA.

5.3.3 Requalification or recalibration shall be performed wherever applicable after major maintenance activity.

5.4 Replacement of Spare Parts:

5.4.1 Only approved and suitable spare parts shall be used.

5.4.2 Spare part details shall be documented in maintenance records.

5.4.3 Defective spare parts shall be segregated and disposed of appropriately.

5.5 Post Maintenance Checks:

5.5.1 After completion of maintenance activity, equipment shall be checked for satisfactory functioning.

5.5.2 Area and equipment cleanliness shall be ensured before releasing equipment for use.

5.5.3 Equipment shall be released for operation only after satisfactory verification.

5.5.4 QA approval shall be obtained wherever applicable before equipment use.

5.6 Documentation:

5.6.1 All preventive maintenance activities shall be documented contemporaneously.

5.6.2 Maintenance records shall include:
5.6.2.1 Date of maintenance
5.6.2.2 Equipment details
5.6.2.3 Description of maintenance activity
5.6.2.4 Spare parts replaced
5.6.2.5 Observations
5.6.2.6 Name and signature of person performing maintenance
5.6.2.7 Verification by Engineering Head/designee

5.6.3 Maintenance records shall be retained as per document retention policy.

5.7 Delayed Preventive Maintenance:

5.7.1 If preventive maintenance cannot be performed as scheduled, justification shall be documented.

5.7.2 Risk assessment shall be performed for overdue preventive maintenance wherever applicable.

5.7.3 Revised maintenance date shall be defined and approved by Engineering Head.

5.8 Breakdown During Operation:

5.8.1 Any equipment breakdown shall be informed immediately to Engineering Department.

5.8.2 Breakdown maintenance activities shall be documented separately.

5.8.3 Equipment impact on product quality shall be evaluated wherever applicable.

5.9 Safety Precautions:

5.9.1 Electrical supply shall be isolated before performing maintenance activities wherever required.

5.9.2 Appropriate personal protective equipment (PPE) shall be used.

5.9.3 Maintenance activities shall be performed in compliance with safety procedures.

5.10 Training:

5.10.1 All concerned personnel shall be trained on this SOP before performing maintenance activities.

5.10.2 Periodic refresher training shall be conducted.

6.0 REFERENCE:

6.1 WHO TRS 986, Annex 2
6.2 EU-GMP Part I, Chapter 3 & Chapter 5
6.3 Equipment Manufacturer Manuals

7.0 RECORDS:

8.0 REVISION HISTORY: