The EXCiPACT Association, an initiative of the International Pharmaceutical Excipients Council (IPEC) Federation, will be exhibiting for the first time at the CPhI Worldwide exhibition being held at the Frankfurt Messe, Germany from October 22 to 24, 2013 at Stand 6.2F61. EXCiPACT is a new, voluntary international certification scheme providing independent third party certification of worldwide pharmaceutical excipient suppliers.
Recently, two German suppliers — Aug. Hedinger GmbH & Co.KG and Merck KGaA — received the first EXCiPACT Certificates issued by mdc medical device certification GmbH, one of EXCiPACT’s internationally-recognized independent third party Certification Bodies. An interview with Merck KGaA about the EXCiPACT process will appear in the October issue of Contract Pharma.
EXCiPACT Certification demonstrates that organizations manufacture and distribute pharmaceutical excipients according to the EXCiPACT Good Manufacturing Practices (GMP) and/or Good Distribution Practices (GDP) Certification Standards. The new program helps meet EU and U.S. regulatory needs for GMP/GDP for excipients.
According to an EXCiPACT statement, both mdc and its auditors underwent a rigorous assessment process in order to become registered, and mdc's auditors completed the formal EXCiPACT training program and were independently witnessed to verify that they met the required, high-level, competency standards.
For more information about EXCiPACT, visit www.excipact.org or contact firstname.lastname@example.org.