The Stuttgart-headquartered firm told in-Pharmatechnologist.com it became the first supplier certified under the scheme on June 25 following a successful audit on February 25.
Copies of the certificates shared with this publication by Frank Milek, Hedinger’s head of GMP and SHEQ, show that operations at the firm’s facility in Teutschenthal in Eastern Germany met the requirements for excipient manufacture, repackaging, analytical testing, warehousing and distribution.
The site – which is due to be re-audited in 2016 – was also found to be in compliance with relevant European pharmacopoeia requirements and EU directive 2001/83/EC.
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.
Last week EMD Millipore – the excipients and processing technology unit of German drugmaker Merck KGaA – became the second firm to pass an excipact audit by mdc medical device certification GmbH/blue inspection body.
Speaking to in-Pharmatechnologist.com on Thursday EMD Millipore said while the Excipact scheme a step in the right direction of the excipients industry and its customers “formal GMP for excipients and enforcement by the regulators would lead to a level playing field."