Standard Operating Procedure for Vendor Qualification for Maintenance Services

1) Purpose

The purpose of this SOP is to establish guidelines for qualifying vendors providing maintenance services to ensure quality, reliability, and compliance with regulatory requirements in pharmaceutical manufacturing facilities.

2) Scope

This SOP applies to all vendors and subcontractors providing maintenance services 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 Procurement Manager collaborates with the Maintenance Supervisor to oversee vendor qualification for maintenance services.

4) Procedure

1. Vendor Selection Criteria
   1. Define criteria for selecting vendors based on qualifications, experience, and capability to perform maintenance activities.
   2. Evaluate vendor compliance with regulatory requirements and quality standards.
2. Documentation and Assessment
   1. Review vendor qualifications, certifications, and past performance records.
   2. Assess capabilities through site visits, interviews, and reference checks.
3. Contractual Agreements
   1. Negotiate contracts specifying scope of work, service levels, and performance metrics.
   2. Include provisions for compliance with safety, quality, and regulatory requirements.
4. Performance Monitoring
   1. Monitor vendor performance through regular audits, evaluations, and customer feedback.
   2. Address non-conformances and implement corrective actions as necessary.
5. Continuous Improvement
   1. Review and update vendor qualification criteria and processes based on feedback and changing business needs.
   2. Collaborate with vendors to identify opportunities for process improvement and innovation.

5) Abbreviations, if any

None

6) Documents, if any

Vendor Qualification Criteria, Contracts, Audit Reports, Performance Evaluations

7) Reference, if any

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

8) SOP Version

Version 1.0