EXCiPACT - A new Certification Scheme for Excipients has been launched
On 1st February, 2012, the IPEC Federation announced the successful launch of EXCiPACT -
its new, voluntary international certification scheme designed and developed to assure
cGMP and cGDP standards are being used in the manufacture and supply of pharmaceutical
excipients.
The following is taken from the press announcement and the webpage of EXCiPACT:
EXCiPACT is a voluntary international scheme provided for the independent 3rd party
certification of manufacturers, suppliers and distributors of pharmaceutical excipients
worldwide. EXCiPACT will be lead by a Global Steering Committee (GSC). This Committee is
comprised of staff or member representatives of the 5 founding project consortium associations -
EFCG, FECC, IPEC-Europe, IPEC-Americas and PQG.
Many excipient suppliers are already certified according to Quality Management System standard,
ISO 9001:2008. This is the basis for the EXCiPACT standards; two annexes to ISO 9001:2008 which
cover GMP and GDP requirements. Thus excipient manufacturers would be assessed according to ISO
9001:2008 and the EXCiPACT GMP Annex, whereas ISO 9001:2008 and the EXCiPACT GDP Annex would apply
to distributors. Those suppliers which do not hold ISO 9001:2008 certification will find the
forthcoming US National Standard (Good Manufacturing Standards (GMP) for Pharmaceutical Excipients)
an alternative approach: this standard is also based on the IPEC-PQG GMP Guide and has been synchronised
with the EXCiPACT GMP and GD P standards during its development.
This additional certification scheme is directed to excipient manufacturers. Manufacturers of medicinal
products who use certain excipients might use the certification for their supplier qualification. The key
question in Europe will be: Will the QPs make use of the certification as part of their supplier qualification?