Recent weeks have seen the passing of several milestones on the way to tightening up security in the pharmaceutical supply chain.
Rx-360 has completed its first supply chain security audit after it issued a set of standards and guidelines in October 2010 based on the IPEC/PQG Good Manufacturing Practices Audit Guide for Pharmaceutical Excipients (2007) and ICH Q7 and EMEA/410/01 revision 2.
When it comes to any sort of scrutiny nobody really wants to be first, so it was courageous of Avantor Performance Materials (formerly Mallinckrodt Baker) to step up to the mark. As a member of the Rx-360 consortium, it was to be expected that the company’s Phillipsburg plant would pass with flying colours, but the management must have breathed a sigh of relief that everything was satisfactory. As Rx-360 chairman Lynne Byers said, this marks a change in the mindset of many companies, and it should be the first of many such audits.
Pharma supply chain security was also high on the agenda at Interpack in May, with a number of coding and marking companies showing innovations.
Travtec Group and Systech International are two of the most recent major beneficiaries of the growing trend towards serialisation of packs and the use of Datamatrix codes to track and trace medicines once they leave the factory.
Travtec has signed its largest contract to date in a deal to supply AstraZeneca with coding and marking equipment worth £1m, while Systech International’s Serialised Product Tracking (SPT) solution has been selected by another of the world’s largest pharma manufacturers for installation on packaging lines in Brazil.
With every supply chain in the world contaminated with counterfeit drugs and internet pharmacies continuing to see trade booming, it is inevitable that more countries will introduce legislation to protect patients; the EU’s Falsified Medicines Directive is just the latest in what is bound to be a long line of such measures.
However, the ad hoc way in which legislation is being introduced, with each government creating different specifications, is a cause for concern. If Big Pharma can set aside competitive pressures and agree on a set of audit standards for the raw material supply chain, then surely there must be an organisation out there that can determine best practice for serialisation and track and trace systems.
Any volunteers?
