Fierce Pharma Manufacturing, April 2015
The tragic loss of patient lives due to contamination of heparin traced back to inferior raw materials in 2008 that were purchased in China was a wake-up call to the pharmaceutical industry regarding the need for improved supply chain security.
Years later, it is worth considering what actions have been taken by industry and regulators to address supply chain security and what results they have achieved.
An Industry Initiative
The Rx-360 Consortium, an industry group focused on sharing information and developing processes to enhance the integrity of the healthcare supply chain that complement the efforts of regulatory agencies was founded in 2008 in response to the heparin tragedy. The group has worked to raise awareness of counterfeiting, product diversion, theft, and other harmful activities and to become established as a key source of supply chain intelligence.
The group also developed a Joint Audit program, which allows multiple companies working with the same business partner to participate in a standardized audit without sacrificing product or process confidentiality, which can save costs and maintain a high audit quality while also increasing the number of suppliers being audited. Rx-360 formed a strategic partnership with BSI Supply Chain Solutions in June 2014 to streamline the audit process and ensure supplier compliance with quality and security standards through verification audits.
In fact, the group is working to expand its reach, both internationally and to other groups involved in the pharmaceutical supply chain, including distributors, carriers, and service providers. In response to the continued globalization of the pharmaceutical industry, an Asia Working Group was established in China in 2013 and Rx-360 is in the process of setting up a similar working group in India. In addition, the Medical Device Initiative was launched in May 2014 to identify and address the supply chain quality and security needs of medical device companies.
Ensuring the security of biopharmaceutical raw materials can be particularly challenging, given the nature of many of these products. One response has been a move away from animal-derived materials for cell-culture manufacturing to chemically defined media. This shift has in turn led to closer examination of the impurity profiles of other raw materials in order to maintain high productivities and yields when using alternatives to serum. Increasingly, in fact, manufacturers of biotherapeutics are expecting raw material suppliers to reduce the risks associated with their products, which includes tracing the origins of all of their raw materials and carefully managing any changes in their supply chains.
In 2011, the Government Accounting Office (GAO) reported that while FDA had increased inspections of foreign API manufacturers by 27% from 2009, the rate of inspection of foreign establishments was still well below that for domestic manufacturers and foreign inspections were generally conducted under conditions controlled by the foreign governments and very different from domestic, surprise inspections.1 Since then, legislation passed in the U.S. has begun to impact agency operations and the pharmaceutical supply chain.
Finally, it should be noted that Section 712 of the Food and Drug Administration Safety and Innovation Act (FDASIA) allows the FDA to enter into written agreements with foreign governments to recognize the inspection of foreign drug establishments. The FDA is in fact working with the European Medicines Association (EMA) on to determine how inspection data may be shared given concerns regarding confidential business information.
- GAO Report GAO-11-936T, "Drug Safety: FDA Faces Challenges Overseeing the Foreign Drug Manufacturing Supply Chain," September 14, 2011. http://www.gao.gov/products/GAO-11-936T Accessed 3/20/2015
- Mansour et al., "United States: FDA And China Agree To Collaborate On Inspections" Jones Day, December 30 2014. http://www.mondaq.com/unitedstates/x/363404/food+drugs+law/FDA+and+China+Agree+to+Collaborate+on+Inspections. Accessed 3/30/2015.