Quality control: strengthening the excipient supply chain

11 October 2013



With reliability and patient safety at the heart of pharmaceutical manufacturing and distribution, Dr Iain Moore of Croda Europe explains why a group of industry experts initiated the EXCiPACT certificate, and how it can reduce weaknesses in the excipient supply chain.


It's an important date on the calendars of pharmaceutical designers, manufacturers, suppliers, distributors, users of pharmaceutical excipients, regulatory bodies and academics alike, but ExcipientFest, held in Maryland, US, at the end of April 2013, was notable this year for another reason.

It marked the formal US launch of EXCiPACT, the new certification scheme for pharmaceutical excipient manufacturers and distributors. The voluntary scheme, which was previously unveiled in Europe at the beginning of 2012, is an international system that provides independent, third-party auditing and certification of excipient manufacturers, suppliers and distributors - in line with current good manufacturing practice (cGMP) and current good distribution practice (cGDP) requirements - throughout the pharma supply chain.

The scheme has been a long time in development. It was initially proposed in 2008, but, according to Dr Iain Moore, global head of quality assurance at chemicals firm Croda Europe and chair of the EXCiPACT certification project, momentum is finally building behind it.

"The key element happening over the past 18 months has been the implementation of a pilot phase," Moore explains. "The design has been completed, and the standards required for the competency of the auditors and for the management systems of the certifying bodies have been proven to be effective.

"Five organisations then went through an auditing process with two certifying companies and six auditors, with the auditors themselves being certified as well. While there is undoubtedly always room for improvement, what the pilot phase showed was that this is a quality-led initiative, and there is nothing fundamental about the scheme's design that needs to be changed."

Following the end of the pilot phase over the summer months, Moore received the green light: the two certifying bodies - mdc medical device certification and SGS Certification Body Munich - were available to provide an EXCiPACT certification auditing service to the industry.

"Once you have got your certificate you are not going to want to see your certification status marked as suspended."

What this translates into in business practice terms is that, to all extents and purposes, the scheme is now 'live' and any supplier that wants to use it can contact one of the certifying bodies and ask to be audited.

"Normally, excipient suppliers will look to do an ISO 9001 audit at the same time as an EXCiPACT GMP or GDP assessment, and have a certificate and audit report that they can share with customers," says Moore. "There will be a level of detail that has not been there before, which excipient suppliers and users will be able to use to demonstrate there is a high-quality supply chain.

"Because of this, there is now an emerging consensus within the industry that this scheme is a good idea, because individual companies will be able to demonstrate their good practices. The indications are that everyone is now comfortable with the EXCiPACT scheme," Moore adds.

An expert panel

EXCiPACT is an independent, non-profit legal entity registered in Brussels. It has been developed via a consortium of the European Fine Chemicals Group, the European Association of Chemical Distributors, the International Pharmaceutical Excipients Council Europe, IPEC-Americas and the UK Pharmaceutical Quality Group.

The scheme is still voluntary, however; something Moore does not see changing anytime soon. Yet, Moore does believe that once a certification or accreditation scheme such as this gathers momentum, it can potentially become de facto, if not compulsory over time.

"I cannot see it becoming mandatory in the short term unless it were to become a European standard or an ISO standard," Moore explains. "Having said that, if you have not got an EXCiPACT certificate then, from a supplier's perspective, it will be more difficult to give the level of assurance your customers require and therefore you could probably expect more audits to take place.This is currently an exciting phase for EXCiPACT; there has been a lot of publicity about it now that it has been fully released, and the indications from our steering group are that interest has already begun to be expressed to certifying groups."

Becoming certified

The aspiration is for EXCiPACT to become the preferred global certification for pharmaceutical excipient manufacturers, suppliers and distributors. But two fundamental questions still exist with regards to the scheme: will the costs involved be justifiable and will it have any validity when it comes into enforcement?

"In terms of cost, it will of course vary, but the audit fee for a three-year EXCiPACT cycle is likely to be in the range of £18,000 to £20,000," says Moore. "If, as a result of this, you then reduce the number of audits received by just one audit a month, you will easily save £75,000 just during those three years."

"This is definitely a step up the ladder that will help us improve the assurance of patient safety."

Although the proposed cost reductions implied by Moore with regard to implementing the EXCiPACT scheme could, in theory, bring financial benefits to a company, there is still some persuasion needed to justify the certification itself. Moore believes, however, that a catalogued database, publicly available, will give levity to the certification.

"Organisations holding an EXCiPACT certificate will be published on the EXCiPACT website - a bit like the certificates of suitability on the EDQM website," he states. "Once you have got your certificate, you are not going to want to see your certification status being marked as 'suspended'."

Time in the making

Audit processes can be extremely fallible and, as such, governments and other regulatory bodies have failed to get schemes into place. The EXCiPACT certificate is yet to be truly tested, as it is only just emerging from its pilot phase. But, despite the shortness of its 'live' lifespan so far, Moore is positive that it will overcome any initial problems.

"All audit processes have their inherent weaknesses, whether they are industry led or not," he continues. "A government-run system would not necessarily be ideal either - not that the government has the resources to do something like this in the current climate. However, one core aspect of the scheme is the requirement that auditor competency is high - not only must they have knowledge of how excipients are made, and GMP, GDP and pharma regulations, but they must also have attended an EXCiPACT training course and have been witnessed in action. We have worked hard to deliver the best audit process we can, and I am incredibly optimistic about EXCiPACT and the future.

"It has taken five years to get to this point, and a lot of planning and consultation. The Medicines and Healthcare Products Regulatory Agency in the UK and the US's FDA both attended our launch presentations, which, to my mind, signals that our regulators consider this to be an acceptable way forward; it signals their acceptance of the EXCiPACT certification scheme," he notes.

Ultimately, time will tell as to whether EXCiPACT can overcome or eradicate the problems that are evident in the excipient supply chain. But a standardised auditing and certifying scheme can only benefit companies in terms of adhering to regulations.

"This is definitely a step up the ladder that will help all of us improve the assurance of patient safety, which is, after all, the main driver behind this," Moore asserts.

"In the 1990s and 2000s, we did see weaknesses begin to emerge in the excipient supply chain, and EXCiPACT is there to help reduce those weaknesses. If we simply carry on doing things the same way, we will get the same result - people exploiting weaknesses in the excipient supply chain.

"The EXCiPACT certification scheme is a key way to ensure that does not happen now or in the future, and in turn it will ensure that we minimise risks while maximising benefits to all parties, but most importantly to the patients," he concludes.

EXCiPACT certification can provide customers with another level of detail.


Privacy Policy
We have updated our privacy policy. In the latest update it explains what cookies are and how we use them on our site. To learn more about cookies and their benefits, please view our privacy policy. Please be aware that parts of this site will not function correctly if you disable cookies. By continuing to use this site, you consent to our use of cookies in accordance with our privacy policy unless you have disabled them.