Multinational excipient-makers will drive US interest in EXCiPACT, the industry-led certification scheme says as a UK Colorcon plant becomes the eighteenth site to receive accreditation.
NSF International has published a new standard and developed an auditing program that can help pharma companies verify regulatory compliance and strengthen safety and quality across their excipient supply chain.
The auditing company, SGS, recently certified that Capsugel’s manufacturing sites in Colmar, France and Bornem, Belgium meet Good Manufacturing Practice (GMP) standards set by EXCiPACT for pharmaceutical excipients manufacturing.
China’s implementation of GMPs for excipient manufacturers, as well as a developing US FDA-style DMF system, have added another layer of safety requirements but challenges remain for the regulators in ensuring compliance, experts say.
The International Pharmaceutical Excipients Council (IPEC) Americas has welcomed new SFDA excipient quality and supervision regulations, which it says are largely consistent with its own guidelines.
German chemical giant BASF chose this year’s AAPS meeting in Atlanta, US to showcase its growing library of USP excipient verification certificates, making good on its commitment to apply the highest manufacturing standards to this area of its business.
BASF's drug excipient manufacturing site in Geismar, Louisiana in
the USA has been accredited under the US Pharmacopoeia's (USP)
voluntary certification scheme.
The costs of introducing any formal good manufacturing practice
(GMP) requirements for potentially high-risk pharmaceutical
excipients in the European Union would far exceed the likely
benefits, concludes an impact assessment for...
Specialty chemicals firm Cognis has received good manufacturing
practice (GMP) certification for its production of pharmaceutical
excipients in Germany, the first chemical company in the world to
do so but certainly not the last.
The pharmaceutical excipients industry urgently needs a system of
European master files, already used by the active pharmaceutical
ingredient sector (API), to stimulate innovation in the sector and
bring Europe's regulatory stance...
Manufacturers of pharmaceutical excipients that are imported into
the US must step up their compliance with new legislation or risk
having shipments turned back at the border.
