Auditee: Our supplier qualification process is a comprehensive approach designed to ensure that our suppliers meet our quality standards, adhere to FDA requirements, and consistently provide materials and services that contribute to the production of safe and effective pharmaceutical products. Here’s an overview of our supplier qualification process and how we ensure compliance with FDA regulations:
Supplier Selection: We carefully evaluate potential suppliers based on their capabilities, reputation, regulatory history, and alignment with our quality standards.
Initial Assessment: Once a potential supplier is identified, we conduct an initial assessment to gather essential information about their processes, quality systems, and regulatory compliance.
Supplier Evaluation: We assess suppliers using a risk-based approach to categorize them based on factors such as the criticality of the supplied material or service and their regulatory track record.
Qualification Audits: For high-risk suppliers, we may conduct on-site audits to thoroughly evaluate their facilities, processes, quality systems, and adherence to FDA regulations.
Documentation Review: We review supplier documentation, including quality certificates, regulatory approvals, and compliance records, to ensure they meet FDA requirements.
Quality Agreement: A quality agreement is established with each supplier. This agreement outlines their responsibilities, quality standards, regulatory compliance requirements, and expectations for continuous improvement.
On-Going Monitoring: We monitor supplier performance continuously through various measures:
- Supplier Audits: Periodic audits of critical suppliers are conducted to assess their ongoing compliance and identify any potential issues.
- Quality Metrics: Key quality metrics are established and tracked for suppliers. These metrics may include on-time delivery, product quality, and regulatory compliance.
- Compliance Checks: We periodically review supplier documentation and regulatory status to ensure ongoing compliance with FDA requirements.
Change Management: Any changes to a supplier’s processes or materials are evaluated for potential impact on product quality and regulatory compliance. This ensures that changes are managed effectively and transparently.
Corrective and Preventive Actions (CAPA): If issues are identified with a supplier, we work collaboratively to implement corrective actions and preventive measures to address the root causes and prevent recurrence.
Continuous Improvement: Our supplier qualification process is subject to continuous improvement. We regularly review and enhance our processes based on industry best practices and regulatory updates.
Through this robust supplier qualification process, we ensure that our suppliers meet FDA requirements, adhere to our quality standards, and contribute to the overall quality and safety of our pharmaceutical products.