At present, the manufacture of excipients is not governed by same strict standards applied to both active pharmaceutical ingredients (API) and drug intermediates, largely because they are produced for a disparate range of uses across a wide variety of industries.
Recent tragedies linked to poorly made or counterfeit excipients have resulted in sugestions from some quarters, including both the USP and the International Pharmaceutical Excipients Council (IPEC) that the industry needs to be subjected to more stringent regulation.
BASF was certified in June this year following the US Pharmacopeia’s (USP) inspection of its manufacturing facilities in Geismar, Louisiana and Ludwigshafen, Germany having become the third firm to sign up to the USP’s voluntary program Iafter ndia's Deepak Fertilizers and Petrochemicals Corp and US-based International Specialty Products.
The certificates on display at the American Association of Pharmaceutical Scientists (AAPS) meeting cover BASF’s Povidone, Crospovidone and Copovidone products, which are part of the polyvinylpyrrolidone Kollidon range that is in widespread usage across the drug industry.
The accreditation means that the products in questions are made in a way that is compliant with both the US Food and Drug Administration's Good Manufacturing Practice (GMP) criteria, as well as the guidelines issued by industry bodies like IPEC and the UK's Pharmaceutical Quality Group (PQG).
Ranga Velagaleti, BASF regulatory manager for quality control, said that the firm’s comittment to USP guidelines will “provide assurance to our customers in the pharmaceutical industry and ultimately, to patients.”