F. 21 CFR (2) requires that a Pharmaceutical Manufacturer prepare written purity, strength and quality specifications for all components, then test each component for conformance to the written specifications. Alternatively, a certificate of analysis from the component supplier may be used if the Manufacturer validates the supplier’s analytical test results at appropriate intervals. All of these requirements are met for Linde’s USP/NF grade products, which are manufactured under cGMP by Linde. Therefore, the Manufacturer avoids most of the cost of conducting these regulatory compliance actions themselves by utilizing Linde USP/NF grade gases. Overall costs for the Pharmaceutical Manufacturer may actually be lower by utilizing Linde’s USP/NF cGMP grade gases in Pharmaceutical manufacturing.
“Having met the stringent requirements contained in the NF and FCC reflects BioAmber’s continued dedication to quality through our best-in-class production and purification processes. By achieving this new benchmark, our global customers in the food, pharmaceutical and dietary supplement industries can be assured BioAmber’s facility adheres to the rigorous quality control standards set by the United States Food and Drug Administration (FDA).” said Fabrice Orecchioni, BioAmber’s President & COO. “This grade will allow BioAmber to supply these high-value industries with commercial volumes of an FDA regulated bio-succinic acid, a grade previously unavailable to these markets before today”, he added.