Industry executives revealed their biggest worries for global supply-chain management in a report by PricewaterhouseCoopers and the analyst firm Axendia that focused on major areas of concern in the pharmaceutical supply chain. The report, titled Achieving Global Supply Chain Visibility, Control & Collaboration in Life Sciences: Business Imperative, Regulatory Necessity, surveyed 112 executives from the pharmaceutical, medical device, and biotechnology sectors.
Half of the respondents said the biggest area of risk is raw materials sourced outside of the US. Sixty-one percent said contaminated or nonconforming raw materials was the top threat in the next five years.
Drug counterfeiting and diversion were seen by executives as major threats to their global supply chains in the next five years, with 44% and 35% of respondents, respectively, citing them as risks. Forty percent of all respondents that produce life science products reported that their company’s products have been counterfeited or illegally diverted. The report says that these threats were “virtually non-existent” as little as 10 years ago, which underscores the rapid growth of the problem of counterfeit drugs.
The growth of globalization presents challenges to industry that the report grouped into three broad categories: on-demand visibility, control over the supply network, and the need for collaboration.
In terms of visibility of their supply chains, 77% of executives said that their primary means of gaining visibility into suppliers’ practices is a periodic audit, 25% said they share common practices and 3% have access to real-time data. The report states that the lack of on-demand visibility is due to the slow speed of gathering information about a company’s supply chain. Regarding the ability to merge data from multiple locations to provide a global view of the supply chain, 66% said they could do it, but they must manually aggregate the data; 15% said that it was not possible; and only 19% said they could do it in real time.
When asked about track-and-trace and serialization technologies, which can help industry gain control over the supply chain, survey respondents said the hurdles to implementing such technology are cost; difficulty of implementation; lack of industry standards; and lack of regulatory requirements and guidance. In terms of specific technologies in use or planned by the executives, 79% said their company uses barcodes, 57% use 2D barcodes, 34% use RFID, 17% use GPS tags, and 8% use none of these measures. Most executives said they could track manufacturing location (84%) and genealogy such as raw material, ingredient, etc., (73%), but 50% or less were able to track elements such as transaction history, chain of custody, record of ownership, environmental storage conditions, and ePedigree.
Industry executives identified the need for collaboration, and said their preferred method for creating best practices around standards is through industry consortium such as the Pharmaceutical Supply Chain Initiative, the Experimental Physics and Industrial Control System, and the Rx-360 consortium.