26 June 2014
SEPPIC obtains EXCiPACT™ certification
SEPPIC became the fourth company worldwide to obtain the quality assurance mark for pharmaceutical excipients
By Kathleen Allain, Marketing Manager, Solid forms, SEPPIC
In December 2013, Seppic was granted the EXCiPACT™ certification as only the fourth supplier worldwide and the first French company.
EXCiPACT™ is a certification created by Excipact, an affiliate of IPEC and launched in January 2012. This certification is provided by an independent third party according to the IPEC/PGQ GMP guidelines. EXCiPACT can be an answer to the suppliers audit requirements of Directive 2011/62/EU known as the “falsified medicine directive”.
EXCiPACT™ certification is voluntary for excipients suppliers and enables the auditee to obtain an audit report based on the IPEC/PGQ GMP guidelines.
Seppic has undergone on audit in September with a very good feedback from auditors. Conclusions of the audit can be given on request.
IPEC (International Pharmaceutical Excipients Council) is a professional association that serves the interests of producers, distributors and users of pharmaceutical excipients. Globally more than 200 companies are members. IPEC represents the views of its members vis-à-vis to appropriate regulatory bodies (European Commision, EMA, European Pharmacopoeia) and is recognised by Government agencies around the world as the voice of European producers and users of pharmaceutical excipients.