Building a Vendor Qualification Program for FDA Regulated Industries

This course will provide detailed explanations and examples for Building a Vendor Qualification Program for FDA Regulated Industry. With today’s pharmaceutical market, raw materials, Active Pharmaceutical Ingredients (API), Containers & Closures, inactive or excipients and other components are being sourced from all over the world. We also have Third Party Manufacturers and outside testing facilities that are part of our supply chains. Building and following a robust vendor qualification Program is essential for pharmaceutical and chemical manufacturers. We must create a procedure, which will be used to remain aware of the compliance status for all of our suppliers. Some raw material components may move from producers to brokers to the end users. In addition, there may be other shippers and wholesalers responsible for moving and holding our raw material components.

Since, all of our components are being used to manufacture finished drug products and API, we must ensure the safety, efficacy and purity of these drug products. Our consumers deserve to have a consistent supply of the finished drugs they use each and every day. Many of our raw material ingredients are manufactured globally and we are required by law (21 CFR Part 211.84, Testing and approval or rejection of components, drug product containers, and closures) to be tested and approved before use in manufacturing. Moreover, FDA’s Drug Supply Chain Security Act (DSCSA) requires that we ensure the safety of drug products as they pass through the supply chain and end up in the hands od consumers. Although, Serialization and Traceability are not being discussed during this conference, our vendor qualification and continuous monitoring of our suppliers must be intermingled with our Supplier Quality Audit Programs.

Learning Objectives:

• The laws that require supplier quality audits
• Writing robust procedures for a robust supplier quality audit program
• Who must conduct these audits
• What are the qualifications needed for conducting supplier audits
• How much experience do auditors need
• Will experienced auditors from another industry suffice for CGMP audits
• The difficulties of scheduling audits
• Required number of days for each audit
• Do we have to cover every single operation during each and every audit
• Focus on the more important audit objectives first

Areas Covered :

• The qualifications of a supplier quality audit
• The contents of an adequate supplier quality audit
• Scheduling and planning audits
• Required length of audits
• Ensuring that all of our questions are adequately conveyed and understood by our suppliers
• How to convince the suppliers that our audits must be accepted and scheduled
• What do we do if the suppliers require us to pay a fee to audit them?
• Do we need secondary suppliers for every component we use?
• Learning how to deal with the difficulties of obtaining Travel Visas