Standard Operating Procedure for Supplier Qualification for Equipment
1) Purpose
The purpose of this SOP is to establish procedures for the qualification of suppliers providing equipment used in the manufacturing of dental dosage forms, ensuring that equipment meets specified quality standards and regulatory requirements.
2) Scope
This SOP applies to the supplier qualification process for equipment used in the production of dental pastes, gels, and mouthwashes within the pharmaceutical industry.
3) Responsibilities
The Purchasing Department is responsible for initiating and managing the supplier qualification process. The Quality Assurance (QA) Department is responsible for reviewing and approving supplier qualifications based on established criteria.
4) Procedure
4.1 Supplier Evaluation
4.1.1 Identify potential suppliers based on equipment specifications and procurement requirements.
4.1.2 Perform an initial evaluation of supplier capabilities, including quality systems, manufacturing practices, and regulatory compliance.
4.2 Supplier Qualification Criteria
4.2.1 Define supplier qualification criteria, including quality standards, technical specifications, and regulatory certifications.
4.2.2 Establish criteria for evaluating supplier reliability, financial stability, and past performance.
4.3 Supplier Audit
4.3.1 Conduct on-site or remote audits of potential suppliers to assess their facilities, processes, and quality control systems.
4.3.2 Review audit findings and assess supplier compliance with qualification criteria.
4.4 Qualification Approval
4.4.1 Evaluate audit results and supplier documentation to determine qualification status.
4.4.2 Obtain QA approval for supplier qualification based on compliance with established criteria.
4.5 Supplier Performance Monitoring
4.5.1 Monitor ongoing supplier performance through periodic reviews, quality metrics, and feedback from internal stakeholders.
4.5.2 Address any supplier non-conformances or performance issues through corrective actions and continuous improvement initiatives.
5) Abbreviations, if any
SOP – Standard Operating Procedure
QA – Quality Assurance
6) Documents, if any
Supplier Qualification Checklist
Supplier Audit Reports
Supplier Qualification Certificates
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
ISO standards for supplier qualification
8) SOP Version
Version 1.0
