Standard Operating Procedure for Supplier Qualification for Raw Materials in Gels Production

1) Purpose

The purpose of this SOP is to establish procedures for the qualification and approval of suppliers providing raw materials used in the manufacturing of gels to ensure consistent quality and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel responsible for supplier qualification and procurement activities within the pharmaceutical manufacturing facility’s gels production department.

3) Responsibilities

Procurement Department: Lead supplier qualification activities and maintain supplier relationships.
Quality Assurance (QA) Team: Review and approve supplier qualification documentation and audits.
Production Supervisors: Ensure raw materials from qualified suppliers meet quality standards.

4) Procedure

4.1 Supplier Selection
4.1.1 Identify potential suppliers based on product requirements and specifications.
4.1.2 Evaluate suppliers based on criteria such as quality, reliability, regulatory compliance, and financial stability.

4.2 Initial Supplier Assessment
4.2.1 Request and review supplier qualification documents, including quality agreements, certificates of analysis, and regulatory approvals.
4.2.2 Conduct on-site audits or assessments as necessary to verify supplier capabilities.

4.3 Qualification Approval
4.3.1 Evaluate supplier qualification documentation against predefined acceptance criteria.
4.3.2 Document approval or rejection of suppliers based on assessment outcomes.

4.4 Ongoing Supplier Performance Monitoring
4.4.1 Establish and maintain a supplier performance monitoring program to assess ongoing compliance with quality and delivery requirements.
4.4.2 Conduct periodic reviews and audits of qualified suppliers to ensure continued adherence to standards.

4.5 Supplier Relationship Management
4.5.1 Maintain regular communication with suppliers to address any quality issues, changes in processes, or regulatory updates.
4.5.2 Update supplier qualification documentation and records as needed based on performance reviews and audits.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance

6) Documents, if any

– Supplier Qualification Checklist
– Supplier Audit Reports
– Supplier Quality Agreements

7) Reference, if any

– FDA Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements
– EU GMP Part I: Basic Requirements for Medicinal Products
– Company-specific supplier qualification procedures and guidelines

8) SOP Version

Version 1.0