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.
BASF's drug excipient manufacturing site in Geismar, Louisiana in
the USA has been accredited under the US Pharmacopoeia's (USP)
voluntary certification scheme.
China is on course to having its own version of the International
Pharmaceutical Excipients Council - joining its fellow
organisations in Europe, the Americas and Japan.
Unlike with active pharmaceutical ingredients (APIs), there are no
clear governmental good manufacturing practice (GMP) guidelines for
excipients in the US, Europe or China. Now the International
Pharmaceutical Excipients Council...
It is no secret that India is becoming a major force in the world
market for active pharmaceutical ingredients, but recent
developments suggest that companies in the country may be gearing
up to play a similar role in inactive ingredients.