EXCiPACT is an excipient manufacturing certification program developed by the European Fine Chemical Group (EFCG), International Pharmaceutical Excipients Council (IPEC) Europe, IPEC Americas, the European Association of Chemical Distributors (FECC), and the Pharmaceutical Quality Group (PQG, based on standards developed by IPEA and PQG published as an annex to ISO 9001.
Certification programs were developed in response to European and US regulations, which require that pharmaceutical manufacturers either audit API and excipient suppliers themselves or rely on third-party auditors to ensure that they meet GMP requirements.
There are currently five routes to third-party GMP assessment of excipients, including audits and certification by IPEC’s International Pharmaceutical Excipients Auditing (IPEA), whose standard was based on USP and the ISO 9001 Annex and accredited by ANSI four years ago, as well as Rx360 audits, EXCiPACT certification, and USP’s excipients verification program.
EXCiPACT’s certification requires that the auditors assessing each manufacturing site, as well as those reviewing them, be specially trained, and that the audit itself be witnessed by GMP experts.
“There is a benefit to its being a formal program, rather than a standard,” Tony Scott, director of communications for EXCiPACT told in-Pharmatechnologist.com.
Currently, 14 sites around the world have EXCiPACT certification. Capsugel’s are the second site in France and the first in Belgium to meet requirements, and the company is the first specialist in encapsulation to receive this certification, said Scott.
Capsugel’s senior vice president of global operations, Anthony Macci, sees EXCiPACT certification as evidence of the company’s commitment to the highest quality standards, and a sign that it is striving for quality and compliance policies that remain a step ahead of current regulations.
“Certification offers an extra level of quality reassurance to customers and, ultimately, consumers and patients. It further saves manufacturers and their customer’s time and costs by reducing the audit burden to ensure compliance with EU regulations,” he said.
Although the certification program is entirely voluntary, Macci added, it is one that is highly regarded.
EXCiPACT, whose standards were finalized three years ago, was launched in Europe in 2012 and a year later in the U.S. It became an independent nonprofit association, incorporated in Belgium, this January.
IPEC has set up a division in China, and Indian manufacturers recently applied for IPEC India’s membership in IPEC to promote excipient safety and quality. The plan is to launch EXCiPACT certification in that country, a leading exporter of pharmaceutical ingredients.
“We are hopeful that it will take off,” Swift said.