Abstract

Highly potent active pharmaceutical ingredients (HPAPIs) represent a growing niche segment in the pharmaceutical market. This article highlights important selection criteria a pharmaceutical company should consider when selecting a CMO for its HPAPI products. The selected CMO should have a clear regulatory based manufacturing strategy and a strong environmental, health and safety (EHS) process. It should have appropriate risk management and risk assessment tools in order to help ensure safe work environments in all of its labs and plants. Appropriate equipment, facility design and working procedures, as well as low personnel turnover are key for a safe and effi cient performance of the HPAPI CMO. A driving factor for long term success lies in having the experts and people needed to execute HPAPI processes. These personnel must be well educated and trained and follow best practices for a safe working culture and environment. Verifi cation performance programs are a good rating, feedback and design aid tool for the capabilities of the CMO systems, procedures and people. Finally, the selection process for choosing a CMO in HPAPI manufacture should not rely on what a CMO claims it can do, but should draw upon historical success and what a CMO already has done. HPAPI manufacturing is not something which can be introduced quickly in an organization. Safe and effi cient HPAPI manufacturing takes long term commitment, years of preparation, signifi cant investment for appropriate plants and supporting facilities, as well as education of people, the right expertise and an ethical commitment of the CMO to the safety of their personnel and environment.