Excipient production at a BASF plant in Lugwigshafen, Germany has been deemed to meet standards set out under the excipact certification scheme.
BASF received the excipact certificate from audit organisation mdc medical device certification GmbH, which visited the plant at which the German chemicals firm manufacturers its range of polyvinylpyrrolidone polymers last year.
The idea is that BASF can provide the certificate to drug industry customers which, in turn, can use it to assure regulators the excipients they use are produced according to appropriate quality standards. BASF meanhwile can avoid duplicate audits.
BASF joins a number of other companies to receive excipact certification. In June excipient maker Aug. Hedinger GmbH was the first firm certified following an audit in February.
More recently EMD Millipore – the excipients and processing technology unit of German drugmaker Merck KGaA - became the second excipact certified manufacturer, receiving its certificate from the same auditing group as BASF.
The voluntary programme was developed by the EFCG, IPEC Europe, IPEC Americas, FECC and PQG to give firms that audit excipient suppliers and distributors a framework for quality assessments in the absence of formal good manufacturing practices (GMP) requirements.
Like the other firms that have been certified, BASF will undergo annual surveillance checks and a recertification audit every three years.
The news about BASF comes as IPEC Federation prepares to launch excipact as an independent scheme.
Speaking at CPhI last year European Fine Chemicals Group (EFCG) vice chairman Frithjof Holtz, head of advocacy at Merck Millipore said: “Excipact, up to now is a project under the legal roof of the IPEC Federation…but we intend to launch it as an independent, not-for-profit association in Brussels.”
He explained that the launch – which is expected to take place in weeks rather than months – will be accompanied by more training courses and efforts to recruit new third-party inspection organisations to join SGS and blue inspection body GmbH, which have both been approved to conduct excipact audits.