EXCiPACT™: Universal seal of approval for pharmaceutical excipients
New internationally accepted certification scheme for pharmaceutical excipient suppliers
Until recently, we had no commonly accepted GMP and GDP (Good Manufacturing Practice, Good Distribution Practice) standards for the pharmaceutical excipients that make up the bulk of most drug formulations. In order to increase product and patient safety and minimize supply chain costs, the pharmaceutical excipients industry started EXCiPACT™ – a new certification scheme for pharmaceutical excipients that grants an independent, one-stop ’seal of approval’ by third-party auditors. EXCiPACT™ is the result of a voluntary initiative of the pharmaceutical excipients industry to ensure excipient quality throughout the entire supply chain by self-regulation. Industry experts from EFCG, IPEC Europe, IPEC Americas, FECC, and PQG are involved in its development. For worldwide acceptance of the new certification scheme, the EXCiPACT™ initiative also collaborates with the Rx360 consortium.
EXCiPACT™ makes GMP/GDP auditing much easier
Excipients often make up a major proportion of a drug – on average about 90 percent of the volume or weight of a given product. At the moment, legislation is on its way in Europe and in the USA requiring cGMP and cGDP compliance for excipients. Suppliers will thus be forced to arrange many more audits than before in order to market their products globally. With the start of EXCiPACT™ in January 2012, this task has now become much easier. Thanks to EXCiPACT™, a single audit will be all it takes to prove an excipient complies with current GMP and GDP requirements.
Minimizing both risks and supply-chain costs
EXCiPACT™ defines cGMP and cGDP standards suitable for 3rd party auditing, auditor competency and training requirements, and certification scheme rules for 3rd party audit organisations resulting in an EXCiPACT™ certificate. Thus, EXCiPACT™ provides independent certification of manufacturers and suppliers of pharmaceutical excipients while minimizing the overall supply chain costs. Merck Millipore has taken an active role in these developments since the very beginning.
Building on existing standards
Since EXCiPACT™ builds on existing ISO standards 9001, organizations already ISO certified can easily extend their ISO certification to the EXCiPACT™ standards. The US national standard ANSI-NSF 363 is equivalent to EXCiPACT™ as well. Requirements are thus always the same independently from the certification route chosen.