The PharmaTech Talk blog summarizes a new report from PricewaterhouseCooper and Axendia entitled, Achieving Global Supply Chain Visibility, Control & Collaboration in Life Sciences: Business Imperative, Regulatory Necessity.
The groups surveyed 112 executives from pharma, medical device and biotechnology sectors. Fifty-percent (50%) of respondents said the biggest area of risk was raw materials sourced outside the US, with sixty-one percent (61%) indicating contaminated or nonconforming raw materials was the top threat in the next 5 years.
Visibility into their suppliers supply chains is limited. Seventy-seven percent (77%) said period audits was their primary means of gaining this information. Only 25% said they shared best practices with suppliers, and a very tiny 3% have any real time data from the supply chain. This would seem to be an opportunity for suppliers to gain advantage by delivering against this need.
With regard to track and trace and serialization technologies, as a means to gain supply chain control, respondents said their current hurdles to implementing this technology are cost, difficulty of implementation; lack of standards, and lack of regulatory requirements and guidance.
As mentioned many times in this blog, SAFC instituted a raw material characterization program approximatley 2 years ago to enhance the analytical and biological characterization of raw materials used in industrial cell culture biomanufacturing and development. The program is clearly aimed at identifying problems with key raw materials that would affect product performance and to fix those issues to deliver increased product performance and consistency.
Posted by Bruce Lehr October 28th 2010.