22/23 February 2024
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 GDP 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?
This interesting new development will be presented at the 3rd Merck Millipore Pharma Forum in Darmstadt (near Frankfurt) on 12 June 2012. Dr Iain Moore, the Project Coordinator will present the details of the new certification Scheme.
The EXCiPACT Scheme will also be covered at the GMP Training Course on "GMP for Pharmaceutical Excipients" on 27-28 September 2012 in Copenhagen, Denmark
For more information please read the EXCiPACT Certification Standard for GMP and GDP.