1) SOP for Vendor Qualification and Audit

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish procedures for assessing and qualifying suppliers, as well as conducting regular supplier audits to ensure compliance with quality standards and regulatory requirements.

3) Scope

This SOP applies to all vendors supplying raw materials, components, and services to the pharmaceutical manufacturing facility.

4) Responsibilities

• Procurement Department: Responsible for identifying potential suppliers and initiating the qualification process.
• Quality Assurance (QA) Department: Responsible for conducting supplier audits and evaluating supplier performance.
• Vendor Management Team: Responsible for maintaining vendor records and monitoring ongoing compliance.

5) Procedure

1. Supplier Identification
   1. Identify potential suppliers based on business needs, product specifications, and regulatory requirements.
   2. Obtain information about the supplier’s capabilities, quality systems, and regulatory compliance status.
2. Supplier Qualification
   1. Request detailed information from the supplier, including quality certifications, manufacturing processes, and product specifications.
   2. Conduct a preliminary evaluation of the supplier’s documentation and capabilities.
   3. Schedule an initial audit of the supplier’s facilities and quality systems.
   4. Prepare an audit plan outlining the scope, objectives, and criteria for the supplier audit.
3. Supplier Audit
   1. Conduct the supplier audit according to the audit plan, focusing on key areas such as quality control, manufacturing processes, and regulatory compliance.
   2. Document audit