This chapter is taken from the book Pharmaceutical Outsourcing: Quality Management and Project Delivery
Here are the key elements to consider when auditing a Contract Manufacturer including the process, ways to identify crucial elements and tips for both CMO and auditor that will ensure success.
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About the Authors
Thomas L. Thorpe has over 30 years of professional experience in pharmaceutical operations, entrepreneurial initiatives and investment banking. He is currently the CEO of Afton Scientific LLC, a cGMP contract manufacturer of sterile drugs.Afton Scientific is also the worldâ€™s premier provider of pre-sterilized (Ready-to-
Use ®) vials and components for cGMP aseptic processing. He is recent Chairman of the Virginia Biotechnology
Association (Virginia Bio) a statewide non-profit organization that promotes the scientific, legislative and economic agenda of the life sciences industry. Mr. Thorpe holds a BS degree in Chemical Engineering from the University of Connecticut and an MBA from University of Virginia.
Jessica Walker is Manager of Quality Assurance for Afton Scientific. She frequently hosts customer audits and performs supplier audits for Afton. She has also successfully hosted multiple drug Pre-Approval Inspections (PAI) and cGMP inspections by the FDA and related inspections by MHRA. She holds a B.S. degree in Biopsychology from the University of California, Santa Barbara.