Standard Operating Procedure for Supplier Qualification and Approval

1) Purpose

This SOP outlines the procedures for the qualification and approval of suppliers to ensure that all materials and services procured meet the company’s quality standards and regulatory requirements.

2) Scope

This SOP applies to all suppliers of materials, components, and services used in the manufacturing of pharmaceutical products within the company.

3) Responsibilities

The Quality Assurance (QA) department is responsible for implementing and maintaining this SOP. The Purchasing department collaborates with QA to ensure that suppliers are qualified and approved before any procurement activities.

4) Procedure

4.1 Supplier Identification and Initial Assessment

1. Identify potential suppliers based on the company’s needs and specifications.
2. Request and review initial information from potential suppliers, including company profile, certifications, and quality management system documentation.
3. Conduct a preliminary assessment to determine if the supplier meets basic qualification criteria.

4.2 Supplier Qualification

1. Send a detailed supplier qualification questionnaire to potential suppliers to gather information on their quality systems, processes, and capabilities.
2. Review the completed questionnaire and supporting documents to assess the supplier’s compliance with regulatory requirements and company standards.
3. Perform an on-site audit of the supplier’s facilities if necessary, focusing on critical aspects such as quality control, manufacturing processes, and regulatory compliance.

4.3 Supplier Approval

1. Compile the results of the supplier qualification process, including the questionnaire review and audit findings.
2. Evaluate the supplier’s overall performance and risk profile to make an approval decision.
3. Approve the supplier if they meet all qualification criteria and document the approval in the supplier management system.
4. Notify the supplier of their approval status and outline any conditions or requirements for maintaining approval.

4.4 Ongoing Supplier Management

1. Monitor the performance of approved suppliers through regular reviews of quality, delivery, and service performance metrics.
2. Conduct periodic requalification audits to ensure continued compliance with quality and regulatory requirements.
3. Document any issues or deviations in supplier performance and initiate corrective actions as necessary.

4.5 Supplier Disqualification

1. Identify and document any significant issues or repeated non-compliance with approved suppliers.
2. Evaluate the impact of these issues on product quality and regulatory compliance.
3. Disqualify suppliers who fail to meet the required standards and communicate the disqualification decision to the supplier and relevant internal departments.

4.6 Documentation and Records

1. Maintain complete and accurate records of all supplier qualification and approval activities, including questionnaires, audit reports, approval decisions, and performance reviews.
2. Ensure that all documentation is readily accessible for audits and regulatory inspections.

5) Abbreviations, if any

QA: Quality Assurance
SOP: Standard Operating Procedure

6) Documents, if any

Supplier Qualification Questionnaires, Supplier Audit Reports, Supplier Approval Records, Supplier Performance Reviews

7) Reference, if any

Regulatory guidelines such as FDA, EMA, ICH Q10 (Pharmaceutical Quality System), and ISO 9001 (Quality Management Systems)

8) SOP Version

Version 1.0