Successful launch

The group was launched in Washington, USA on 5 June 2009. Meeting participants were a diverse group of people from large and small pharmaceutical and biopharmaceutical companies, suppliers, industry organisations, and also the FDA. Live polling was used to get immediate audience feedback on the consortium’s goals and proposed plans. More than 60% of attendees felt that their current organisation did not have a well-established mechanism to track and mitigate supply chain risk.

In his address, Mr Van Trieste elaborated on four distinct functions of the consortium: managing shared supplier audits; adopting standards and best practices; acting as a clearinghouse for suspicious events; and developing technology. The meeting decided to make the adoption of shared audits the first priority.

Membership builds rapidly

8 March 2010 saw the start of a pilot plan to allow pharmaceutical manufacturers to share audits of suppliers. By then the consortium had an Audit Standards Working Group with 27 participants, representing 19 companies and organisations.

On 16 September 2010 over 125 global attendees, representing some 89 organisations from across pharmaceutical, biotechnology and generic drug manufacturing industries, along with their suppliers, professional trade associations and regulatory agencies, came together at Merck KGaA in Darmstadt, Germany, for the 2010 Open Meeting. Approximately half of those attending were from organisations considering joining the 52 organisations already in Rx-360.

Value for money

At US$4,000 to 10,000 (Euros 2,900 to 7,200) annually, membership is not cheap, but it makes sense to Mr Jonathan Fawdry, General Manager of Fagron UK. Fagron is the only multinational one-stop-shop for products and services for pharmaceutical compounding in Europe and US. Fagron provides high-quality raw materials, active pharmaceutical ingredients and semi-manufactured products for compounders. It operates in over 20 countries worldwide, with over 100,000 customers, including pharmacies, hospitals, pharmaceutical, veterinary, cosmetic and other manufacturers.

“With several hundred suppliers for our more than 1,500 core products, supplier and product qualification is a key issue. Our customers who make individual medicines and buy 200 grams need access to the same documentation and audits as those who buy 200 metric tonnes” he explained.

Rx-360’s goals complement those of the FDA and the EMA and it has the support of both bodies.

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