US preference for ANSI 363 excipient standards will change, says EXCiPACT

By Dan Stanton

- Last updated on GMT

EXCiPACT's industry-led accreditation scheme can ensure drugmakers subscribe to GMP regulations through audits of third-party excipient-makers
EXCiPACT's industry-led accreditation scheme can ensure drugmakers subscribe to GMP regulations through audits of third-party excipient-makers

Related tags International pharmaceutical excipients Audit

Multinational excipient-makers will drive US interest in EXCiPACT, the industry-led certification scheme says as a UK Colorcon plant becomes the eighteenth site to receive accreditation.

The Colorcon excipient facility in Dartford, UK received certification last week after being audited by SGS France, an independent body qualified to grant EXCiPACT accreditation.

Certification “permits the supplier to proactively demonstrate commitment to cGMP and cGDP in the manufacture and supply of their pharmaceutical excipient,” ​Colorcon spokesperson Deborah Taylor explained, who added that it "is a further demonstration of commitment to the highest standards for quality and reducing audit and regulatory burden for our customers,”​ 

EXCiPACT scheme

The industry-led scheme began life in 2007 with an EFCG paper proposing a set of standards for pharmaceutical excipients which were embraced by industry bodies including International Pharmaceutical Excipients Council (IPEC) and the European Association of Chemical Distributors (FECC).

“APIs were thoroughly regulated but there were no equivalent regulations for excipients,”​ EXCiPACT spokesman Tony Scott told

The 2011 Falsified Medicines Directive​ and the 2012 FDA Safety and Innovation Act (FDASIA)​ – in the EU and US respectively – now demand physical audits of material suppliers, but Scott said the EXCiPACT standards, created by over 45 industry experts, pre-empted such legislation and helps drugmakers deal with an “increasingly enormous burden”​ through shared excipient-maker audits, saving time and money.

International Accreditation

Colorcon joins Capsugel​ as one of only a few US firms to have sought certification through EXCIPACT rather than the ANSI 363 standard​ devised by NSF International.

Earlier this year EXCIPACT decided to allow approved certification bodies to use ANSI 363 in EXCIPACT audits after deeming it to be equivalent to its own standard combined with ISO 9001.

But, while the move may prompt international firms with US operations to seek EXCIPACT certification, Scott told us he expects US suppliers to continue to stick to with what they know.

“All things being equal, the US tends to be parochial in product choice and to look internationally in such a situation for an alternative is not common,” ​Scott told us.​ 

“However, EXCiPACT is confident that international companies based in the US will begin to select EXCiPACT as it offers a proven international scheme based on a high degree of auditor competency and oversight of the certification bodies. In addition, EXCiPACT GMP has already been used as the basis of the Rx-360 audit guide for excipients.”

Currently, EXCiPACT’s programme has certified plants in Europe, Canada, Saudi Arabia and - most recently – two sites in India.

“We are just starting to see interest in China which is really good news as they too want to demonstrate they are manufacturing high quality safe excipients,” ​Scott said.

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