In December 2013, SEPPIC became the first French company and only the fourth company worldwide to obtain EXCiPACT™ certification.
EXCiPACT™ is a quality assurance mark which certifies compliance with Good Manufacturing Practice for pharmaceuticals excipients. Certification was awarded to SEPPIC by Medical Device Certification GmbH (MDC), one of the international auditors authorized to grant approval under this standard, for the SEPIPROD site at Castres, France. The site obtained certification for its excipient manufacturing process, covering inter alia the quality management system, storage, quality control and production.
SEPPIC constantly moves forward in step with its clients in a way that guarantees progress on both sides. EXCiPACT™ is an illustration of SEPPIC’s fierce commitment to a sustainable approach to risk management and quality control.
European and US regulations require holders of Marketing Authorizations to audit all their raw materials suppliers for compliance with Good Manufacturing Practice (GMP) and/or Good Distribution Practice (GDP). Carried out by an external body and based in international GMP/GDP standards, EXCiPACT™ certification is internationally recognized. This new standard provides assurance in respect of quality and best practice. With immediate effect, it will enable users and manufacturers to reduce their auditing costs while retaining complete assurance as to the quality of the products supplied.
Kathleen Allain, Pharmaceuticals Marketing and Development Manager, says:
“EXCiPACT™ Certification is a real asset both for SEPPIC and for our clients. In today’s environment, it has become essential for excipients to meet the highest possible quality standards. Certification is proof of SEPPIC’s desire to supply excipients in line with the needs of pharmaceutical manufacturers.”