Regulated Vendor Management System

Authors

Stephen Wehrer, MBA, CEBT; Adam Pedersen, AS

Abstract

As providers of human ocular tissue for transplant, we will enter into agreements with organizations that perform or support a manufacturing step on our behalf. For example, an eye bank may send a cornea determined eligible for transplant to another eye bank for specialized processing (e.g., laser-enabled keratoplasty). FDA provides guidance on the responsibility of the customer (the source eye bank in this case) in ensuring the vendor’s (the processor in this case) regulatory compliance. A modern eye bank is likely to have many vendors performing and supporting manufacturing steps like: serology testing, record storage, media storage, tissue processing, and perhaps terminal sterilization. The purpose of this review is to outline one eye bank’s system for onboarding, maintaining, and addressing nonconformances with such Regulated Vendors.