Standard Operating Procedure for Subcontractor Management

Purpose

The purpose of this SOP is to establish procedures for the selection, qualification, and oversight of subcontractors within the pharmaceutical distribution facility, ensuring that subcontracted activities are conducted in compliance with regulatory requirements and meet quality standards.

Scope

This SOP applies to all personnel involved in the selection, qualification, monitoring, and evaluation of subcontractors, including procurement managers, quality assurance professionals, and department heads.

Responsibilities

• The Procurement Manager is responsible for overseeing subcontractor management activities and ensuring compliance with procurement policies, quality standards, and regulatory requirements.
• The Quality Assurance Manager is responsible for establishing subcontractor qualification criteria, conducting supplier audits, and monitoring subcontractor performance to ensure adherence to quality and regulatory standards.
• All personnel involved in subcontractor management are responsible for following procedures outlined in this SOP, including the evaluation and documentation of subcontractor performance.

Procedure

1. Subcontractor Selection:
   • Identify potential subcontractors based on the required services or activities and assess their capabilities, experience, and compliance with regulatory requirements.
   • Establish selection criteria for subcontractors, considering factors such as quality systems, regulatory compliance, technical expertise, and financial stability.
2. Subcontractor Qualification:
   • Conduct a thorough qualification process for selected subcontractors, including documentation review, site inspections, and assessment of quality systems and capabilities.
   • Verify subcontractor qualifications through audits, supplier questionnaires, and qualification assessments to ensure their ability to meet quality and regulatory requirements.
3. Contractual Agreements:
   • Negotiate and establish contractual agreements with qualified subcontractors, clearly defining expectations, responsibilities, quality requirements, and regulatory obligations.
   • Ensure that subcontractor contracts include provisions for quality assurance, regulatory compliance, confidentiality, liability, and dispute resolution.
4. Subcontractor Oversight:
   • Monitor subcontractor performance through regular assessments, audits, and performance reviews to ensure compliance with contractual agreements, quality standards, and regulatory requirements.
   • Address any non-conformities or deviations identified during subcontractor oversight activities and implement corrective actions as necessary.
5. Performance Evaluation:
   • Evaluate subcontractor performance periodically based on predefined performance metrics, such as quality, timeliness, reliability, and customer satisfaction.
   • Document subcontractor performance evaluations and use the results to make informed decisions regarding continued engagement, improvement opportunities, or termination of subcontractor relationships.

Abbreviations

• SOP – Standard Operating Procedure

Documents

Reference documents related to subcontractor management may include:

• Subcontractor qualification criteria
• Subcontractor contracts
• Subcontractor performance evaluations
• Supplier audit reports
• Regulatory guidelines on supplier management

Reference

Good Distribution Practice Guidelines

SOP Version

Version 1.0