Rx-360 concept finds favour with European audience

Last week, the Rx-360 consortium followed up its official launch in the USA in June with a UK event designed to stimulate interest in the project among the European pharmaceutical sector.

The event, held at GlaxoSmithKline's headquarters in London, provided an opportunity for Rx-360 to gauge the reaction of European companies to its mission, which is to try to bring pharmaceutical manufacturers, suppliers, distributors and brokers into alignment with a global, consistent and auditable set of quality standards.

Clear and consistent standards and audits should reduce the administrative burden on companies and "enhance product quality and authenticity throughout the supply chain," according to the consortium's mission statement.

Using handheld devices to vote, 80 per cent of the 130-plus meeting attendees agreed that an approach such as that envisaged by Rx-360 was needed.

Presenting the rationale for the project, Rx-360 vice chair Lynne Byers of GlaxoSmithKline set the scene by pointing to the recent scandals associated with heparin adulteration and contaminated glycerin which have dented confidence in the pharmaceutical industry and raised concerns that rapid globalisation in raw material supply chains is putting quality and therefore patient safety at risk.

"Rx-360 was formed at the beginning of this year in response to these recent events," Byers told the meeting, stressing that the group's work "is not intended to replace the regulatory system or to eliminate regulatory oversight."

The plan is that the consortium will have several functions, she continued, including the development of common standards for quality and authenticity of suppliers, and a system that will allow industry to share supplier audit results in a centralised database. The latter's aim is to reduce the cost and time burden on suppliers as well as pharmaceutical manufacturers and improve the quality of information gleaned from audits. 

Other objectives include monitoring macroeconomic and political developments that could impact on ingredient quality, and the development of common standards for authentication and track-and-trace technologies.
 
Shared supplier audits

Topping the list of topics discussed at the meeting was the development of shared supplier audits.

At present, Rx-360 is envisaging three types of shared audit, including:

- Sponsored audits; i.e. those sponsored by a pharmaceutical company and carried out by an Rx-360-qualified auditor or the sponsor company itself. The sponsor would pay for the audit and receive a payback when other members request a copy.

- Audits led by Rx-360; where a particular need for supplier certification is identified - for example by polling the membership - and the costs are shared among the consortium members;

- Subscription based audits; where each member's existing audits are placed in the Rx-360  database to be shared by all members.

Shared audits would also provide greater depth of information, as the reduced frequency would allow more time to be spent for each individual audit.

Martin van Trieste, Rx-360's chair, believes that regulations being proposed around the world are recommending auditing excipient manufacturers at a frequency which simply may not be achievable using the current systems. Even now, the poll of the audience found that just 16 per cent of companies audited every one of their suppliers.

"The vast majority of us simply don't have the resources to audit all our suppliers right now," said van Trieste. "If all the legislation currently being debated is implemented it could increase the number of audits required by 1 million each year."

Rx-360 data suggest that audits can cost $7,000 to $10,000 each, but shared audit costs can be reduced to $800 to $2,000. That equates to a saving of $50m to $80m year if 100 members share 50 audits.

A number of issues still need to be ironed out. For example, concerns were raised about the liability of companies who relied on someone else's audit should something go wrong with an ingredient. There was discussion about the lifespan of an audit, in terms of reaching a consensus on how long it would be valid, and anti-competitive issues such as ensuring that one supplier's audit does not fall into the hands of a rival.

Adopting standards and best practices is the second key element of the programme, although here the aim will be to draw on the body of work that has already been carried out by industry in this area. "We want to adopt the standards that are already there, but if there are gaps we will work to close them," Byers told the meeting. 

Standards in the cross-hairs cover elements such as right size testing, pedigree, supplier site and distribution channel certification and reporting of and responding to suspicious events.

The third area is monitoring what is happening in the operating environment in order to try to anticipate emerging threats to supply chain security. An example is Rx-360's already completed work on the development of alternative tests for acetonitrile, a solvent widely used in pharmaceutical manufacturing but which has become scarce as a result of the slowdown in the economy and its effect on the chemical industry.

With prices rocketing, Rx-360's alternative test was made freely-available so that diluted or adulterated acetonitrile can be detected before the material enters the medicines supply chain.

Finally, the consortium hopes in time to be able to help with the development of supply chain security and anti-counterfeiting technology and help companies choose appropriate solutions out of the frankly bewildering array of technologies already on offer.

"We want to work with universities and other groups [and] pool resources to develop innovative technologies for prevention and detection," she said.

When asked about which of Rx-360's objectives they support, 52 of attendees said shared audits; 25 per cent said adopting industry standards; 10 per cent said monitoring; and 13 per cent said technologies.

And while the 80 per cent endorsement of the need for Rx-360 in Europe was lower than the 100 per cent thumbs up by US companies earlier in the year, there is still considerable momentum behind the scheme.

By the end of the European launch day, 89 per cent of the participants said at the meeting they were certain, likely or considering joining Rx-360, but it is critical that words of support are followed in equal measure by action, according to Byers.

"We need big industry uptake of this scheme so that it becomes more meaningful," she told the meeting, adding that the objective is to identify best practices and implement them quickly, with the intention of refining them thereafter.

"Perfection is the enemy of good in this case," she said. "It has to be good enough - in other words well thought-through and bought into by members of the consortium - but we don't need to go for 110 or 120 per cent at the outset."