Determining the Value of Re-Shoring Drug Ingredient Manufacturing

BioSpectra would like to publish the slide deck from President Richard Mutchler’s presentation on “Determining the Value of Re-Shoring Drug Ingredient Manufacturing” and a Supply Chain Risk Assessment form. The material was presented in May at CPhI North America to a large hall and garnered positive responses. Topics included the efforts of validating foreign manufacturing to appropriate compliance guidelines, maintaining a supply chain for pharmaceuticals to ensure appropriate material intended use and evaluating the benefits of manufacturing within jurisdiction of the governing compliance agency.

The presentation was followed by a panel discussion led by BioSpectra’s General Manager, Sarah DeMaio, and Director of Regulatory Affairs, Dora Meissner. The panel focused on several case studies of companies that have re-shored manufacturing and explored the resulting benefits as well as the short and long term returns on investment. The Supply Chain Risk Assessment form was provided to the audience to evaluate their current supply chain and to ensure compliance under the FDA’s ongoing efforts to improve drug safety.

Background Information: Mr. Mutchler founded BioSpectra in 1994 to create safe, traceable and cost effective versions of life science materials. BioSpectra is committed to ensuring consistent therapeutic effect of pharmaceuticals in each dose by using materials designed, manufactured and intended for use in drug manufacturing. BioSpectra manufactures GMP APIs, Excipients and process aids in accordance with IPEC and ICH Q7 guidelines at its two facilities in the US.

Supply Chain Risk Assessment Form

Presentation Slides