Building a Vendor Qualification Program for FDA Regulated Industries
President, Brian G. Nadel, GMP Consulting, LLC
President, Brian G. Nadel, GMP Consulting, LLC
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.
One of the most important objectives during this conference is to write or enhance our Supplier Quality Audit Programs. If you already have a written procedure for conducting supplier quality audits, is this Standard Operating Procedure (SOP) sufficient to comply with all of the Current Good Manufacturing Practice for Finished Pharmaceuticals and ICH Q7 (Good Manufacturing Practice for Active Pharmaceutical Ingredients). We will learn about why we need to regularly audit these suppliers. Also, we must determine a sufficient frequency for conducting audits of all of our suppliers. There are many companies that can conduct Third Party Audits for our companies. Does FDA accept the use of Third Party Audits? Do we need to have two, five, twenty-five, fifty or one hundred Supplier Quality Auditors working at our firms? This depends on the number of suppliers that we have and how often we purchase from these suppliers. Is it acceptable to simply send the suppliers Questionnaires? Are these surveys considered to be an acceptable substitute for direct, physical audits of these suppliers?
We will also learn about estimating the time and travel expenses for these supplier quality audits. We need to have adequate funds to pay for these audits. We will also learn how to write and why we need to prepare audit agendas. What should we do if we do not cover every single item on our audit agendas? The recommended contents of a Supplier Quality Audit Report will also be taught during this presentation.
Brian G. Nadel is the President/Sole Proprietor of Brian G. Nadel, GMP Consulting, LLC. He has over twenty-five years of diverse experience in: Pharmaceutical Quality Assurance and Quality Systems; FDA Pre-Approval and Inspection Readiness Inspections; International CGMP Auditing for finished drug products, Active Pharmaceutical Ingredients, Fermentation, Process Validation and botanical extraction.
Mr. Nadel utilizes his broad background to assess compliance issues and develop effective, efficient comprehensive systems to ensure CGMP Compliance. He assists pharmaceutical firms in maintaining and developing quality manufacturing operations. He has worked with NDA, ANDA, DMF, BLA and OTC product manufacturers. He has also conducted CGMP training for FDA, Industry and at industry conferences. He has worked to assist clients to comply with the requirements of Consent Decrees. He has used his experience in the pharmaceutical and government regulatory industries to author SOPs in quality and compliance areas.
Mr. Nadel holds a BA in Microbiology and Parasitology from the State University of New York at Albany, NY and is a certified Regulatory Affairs Professional. He is a member of the Parenteral Drug Association and the Regulatory Affairs Professional Society. Mr. Nadel has spoken at many industry conferences, including three conferences in India in 2017.
Mr. Nadel has just completed his third trip to India in 2017. During these visits, he has been working with Indian Pharma to train them to proactively prevent problems and respond to “issues” with the US FDA.
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