The Ashland site in Calvert City was deemed to comply with good manufacturing practices (GMP) standard for the production, testing and packing of polyvinylpyrrolidone (PVP) and polyvinylpolypyrrolidone (PVPP).
Deneen Law, global pharmaceutical marketing and innovation director Ashland, said: “The transparency and global reach of this certification program will further patient safety through consistent, global quality standards.”
Ashland said it hopes all of its excipient facilities will be certified by 2017.
An Excipact spokesman told us it is delighted Ashalnd has "adopted our GMP Certification Scheme for one of their US manufacturing sites. We hope this is the first of many.
Prior to Ashland, Canada-based A & C American Chemicals was the only North American manufacturer to seek and gain the status.
The majority of US excipient firms have chosen to seek accreditation under ANSI 363 standards devised by NSF International.
However, last year Excipact decided to allow approved certification bodies to use ANSI 363 in audits after deeming it to be equivalent to its own standard combined with ISO 9001.
At the time a spokesman for the Belgium-based organisation predicted the decision would prompt some US manufacturers to seek certification.
He told us the organisation was confident “companies based in the US will begin to select Excipact as it offers a proven international scheme based on a high degree of auditor competency and oversight of the certification bodies.
The spokesman also pointed out that the scheme “has already been used as the basis of the Rx-360 audit guide for excipients.”