Martin VanTrieste, R.Ph.
Vice President Quality
Amgen, One Amgen Center
Mail Stop: 37-2-C
Thousand Oaks, Ca 91320,
Tel: +1 (805) 313 1524
A Pharmaceutical Supply Chain Consortium
Rx-360 is a consortium being developed by volunteers from the Pharmaceutical and Biotech industry which includes their suppliers. The purpose is to enhance the security of the pharmaceutical supply chain and to assure the quality and authenticity of the products moving through the supply chain. The individuals developing this concept are working in the best interest of patients. We are a non-profit organization with the mission to create and monitor a global quality system that meets the expectations of industry and regulators that assures patient safety by guaranteeing product quality and authenticity throughout the supply chain.
Management of the pharmaceutical supply chain has become one of the top public health concerns with respect to consumer safety. The globalization of distribution for both drug components and finished products has introduced many complications that to date have yet to be resolved. Unethical players and noncompliant companies along the supply chain can introduce counterfeited, adulterated and contaminated materials, often with tragic consequences. Naturally, such incidents lead to a loud and swift reaction from the public, the health authorities and the policy makers.
As regulators, pharmaceutical executives, supplier executives and members of professional organizations, our ultimate mission is to serve patients. Millions of people around the world are treated everyday with the vital medicines that we collectively provide. That is what we do. However, the threats to the supply chain have not only prevented us from treating patients, but have caused the deaths of hundreds if not thousands of the individuals we are trying to serve.
In order to achieve this mission, we require secure and reliable supply chains that deliver the right materials at the right quality so that these vital medicines can be trusted by health care practitioners and patients.
Legislators, regulators, and other organizations around the world are developing and implementing local measures to curtail these activities or mitigate their impact. A global consortium will complement these efforts and deliver a level of consistency and scope world-wide, that local measures cannot achieve.
In support of its mission to develop and implement enhanced global quality systems and processes to help members ensure product quality and authenticity throughout their supply chains, the Consortium may undertake the following activities:
(i) development of voluntary standards for the quality and authenticity of supplies and suppliers;
(ii) development and implementation of audit standards and auditor training and certification regarding the quality and authenticity of supplies and suppliers;
(iii) joint development of technologies to enhance the quality and authenticity of supplies;
(iv) development and implementation of a method for exchanging among members public information regarding the quality and authenticity of supplies and suppliers and non-public information regarding the quality and authenticity of supplies and suppliers that could adversely impact patient health or welfare; and
(v) adoption of a seal for use by members that meet the Consortium’s standards.