Standard Operating Procedure for Maintenance Documentation and Record Keeping

1) Purpose

The purpose of this SOP is to establish guidelines for the documentation and record keeping of maintenance activities to ensure compliance with regulatory requirements and facilitate effective maintenance management in pharmaceutical manufacturing facilities.

2) Scope

This SOP applies to all maintenance activities conducted within pharmaceutical manufacturing facilities, including equipment, utilities, facilities, and safety systems.

3) Responsibilities

The Facility Management Department is responsible for implementing and adhering to this SOP. The Maintenance Supervisor is responsible for overseeing maintenance documentation and record keeping.

4) Procedure

1. Documentation Requirements
   1. Document all maintenance activities, including preventive maintenance, corrective maintenance, calibration, and equipment validation.
   2. Record details such as date, time, personnel involved, equipment/system serviced, procedures followed, and findings.
2. Record Keeping
   1. Maintain organized records in a secure and accessible location.
   2. Ensure records are legible, complete, and accurate.
   3. Archive records according to regulatory requirements for easy retrieval during inspections.
3. Retention Period
   1. Follow regulatory guidelines for the retention period of maintenance records.
   2. Dispose of records according to established procedures after the retention period has expired.
4. Review and Audit
   1. Regularly review maintenance records to identify trends, opportunities for improvement, and compliance issues.
   2. Conduct internal audits of maintenance documentation to verify completeness and accuracy.

5) Abbreviations, if any

None

6) Documents, if any

Maintenance Logs, Inspection Reports, Calibration Certificates, Equipment Validation Reports

7) Reference, if any

Relevant regulatory guidelines such as FDA, EMA, and WHO GMP requirements for documentation and record keeping of maintenance activities in pharmaceutical manufacturing facilities.

8) SOP Version

Version 1.0