Standard Operating Procedure for Contractor Management in Maintenance

1) Purpose

The purpose of this SOP is to establish guidelines for the management of contractors involved in maintenance activities to ensure safety, compliance, and efficiency in pharmaceutical manufacturing facilities.

2) Scope

This SOP applies to all contractors and subcontractors performing maintenance activities 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 contractor management in maintenance.

4) Procedure

1. Contractor Selection
   1. Define criteria for selecting contractors based on qualifications, experience, and safety record.
   2. Verify contractor licenses, insurance, and compliance with regulatory requirements.
2. Contractor Orientation
   1. Provide orientation and training to contractors on facility policies, safety procedures, and emergency protocols.
   2. Review scope of work, expected outcomes, and performance expectations.
3. Work Permitting Process
   1. Issue work permits for contractor activities, specifying scope, duration, and safety requirements.
   2. Ensure contractors follow established procedures and safety protocols during work execution.
4. Performance Monitoring
   1. Monitor contractor performance and compliance with contractual obligations.
   2. Address any deviations from scope or safety protocols promptly.
5. Documentation and Reporting
   1. Maintain records of contractor qualifications, work permits, safety training, and performance evaluations.
   2. Document incidents, near misses, and corrective actions related to contractor activities.

5) Abbreviations, if any

None

6) Documents, if any

Contractor Qualification Records, Work Permits, Safety Training Logs, Incident Reports

7) Reference, if any

Relevant regulatory guidelines such as FDA, EMA, and WHO GMP requirements for contractor management in pharmaceutical manufacturing facilities.

8) SOP Version

Version 1.0