Heparin highlighted the threat posed by substandard medicines and placed emphasis on drug quality control at the US Food and Drug Administration (FDA). In response the FDA has worked with the US Pharmacopeia (USP) on quality standards and is now extending the relationship.
“This agreement strengthens the long-standing public-private partnership between FDA and USP, which has its roots in the early years of the 20th century”, said Roger Williams, CEO of the USP.
Signing the three-year cooperative research and development agreement builds upon the long-standing relationship and provides a platform for modernising drug quality control.
“It is vital that quality standards deploy current science and technologies, and not rely on methodologies that reflect earlier levels of scientific understanding”, said Williams.
Modernising quality
In collaboration with the FDA the USP will modernise tests and assays included in its written or documentary standards. The partners are also developing use of hand-held instruments for law enforcement inspectors to test drug quality in the field.
Advances in hand-held detection devices have increased interest in the tools. The FDA plans to use them to detect counterfeit and substandard medicines and the USP will use its experience to support this process.
Finally, the partnership furthers annual collaborative testing of 40 chemical reference standards. Controlled substances are the focus of this laboratory testing effort. Combined these efforts are intended to ensure the quality, identity, purity and strength of medicines.
“The two organisations’ strong scientific expertise and laboratory capabilities complement each other, and the USP reference standards programme is an important component of the FDA lab-based regulatory programmes”, said Carl Sciacchitano, director of FDA’s division of field science.