By Jason Merryman, Senior Director, Automation, Kymanox Corporation
The FDA designates an outsourcing facility that produces sterile injectable medication as well as other sterile medical products as a 503(b) compounder. Working with 503(b) compounding facilities requires special attention to the associated regulations, including commissioning and qualification of equipment and clean room facilities, to maintain cGMP and drug supply chain security compliance. This case study examines a 503(b) compounder with two facilities that required support for doubling manufacturing capacity, which entailed designing and managing the buildout, commissioning, and qualification of new ISO 7 clean rooms for sterile and parenteral injectable manufacturing and general operations expansion. Additionally, assistance for Active Pharmaceutical Ingredient (API) scaleup, clean room recertification project management and leadership, quality system workflow management, and process/facility validation were required.