Building a Robust 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.

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.

AGENDA

Course Director: JOY MCELROY 

Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. She began at Pharmacia & UpJohn performing environmental monitoring and sterility testing. From there she moved into a supervisory role at Abbott Laboratories where she oversaw the quality control lab. In 1998, Ms. McElroy moved to Wyeth Lederle and worked in quality assurance, performing GMP compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in quality assurance for a few years, she moved into equipment qualification and cleaning validation at Mallinckrodt. She has worked all around the United States performing GMP compliance audits, writing and executing cleaning validations, equipment qualifications, and performing technical writing. With over 30 years total experience in the pharmaceutical and biologics industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, environmental monitoring, equipment qualification, sterilization, GMP compliance auditing, and technical writing.  Joy currently works for Actalent Services, LLC as the Validation Manager for sciences where she works with a team of highly qualified technical individuals to provide managed services to pharmaceutical, medical device and biologics companies around the world.