Small scale and clinical manufacturing have different requirements than full-scale, commercial manufacturing, but needs to fulfill the same standards concerning aseptic handling. A prime example of this are the compounding pharmacies, academic institutions and hospitals. This session will look more closely at the challenges faced for these operators and will explore the solutions that they found.
Robert Bosch Packaging Technology GmbH
Associate Director, Drug Product Operations
Teva Pharmaceuticals - West Chester, PA
Assistant Director, Global C&Q
Senior GMP Quality Expert
Director Business Development, UIP
University of Iowa Pharmaceuticals
[Case Study: Implementation of a Clinical Scale Flexible Filling Line using Single Use Systems]
Speaker: Andy Halsey
A case study for implementation of a small flexible filler using single use technologies will be presented. The focus of the presentation will be on the transition from validation into clinical production from the owner’s perspective, including use of risk assessment strategies, technical challenges overcome, integration of multiple vendor technologies, and some key lessons learned.
[The Trials and Tribulations of Becoming a Sterile 503B Outsourcing Facility ]
Speakers: Jerry Chapman and Jason McGuire
FDA’s recent creation of the 503B compounding outsourcing facility has led many pharmacies to declare themselves a 503B facility, which can be a lucrative space to be in. However, as evidenced by the number of FDA 483s and warning letters, many are finding the transition challenging. This presentation will review the expectations that come with the 503B designation, including the need to follow Good Manufacturing Practices, which mandates a separate quality unit and specific requirements to be discussed during the session.
[U of Iowa Pharmaceuticals - Innovative Facility/Process Design and Delivery]
Speakers: Randy Yeates and William Bennett
Using innovative facility and process design to meet unique business needs and niche customer demands, and a risk-based approach to deliver commissioning and qualification: first the new facility must be flexible enough to support many customers and products while still maintaining full cGMP compliance. Second, the facility must be designed to handle phase I/II clinical to small-volume commercial batch size. Third, the new facility must be state-of-the-art including isolator-based, fully automated filling, vial processing, and lyophilizer loading. Fourth, the new facility must be qualified in a science-based, risk-based, cost-effective, schedule-sensitive manner.