11-Jan-2010

Merck KGaA is a founder member of Rx-360

Rx-360 is a not-for-profit, international consortium developed by members of the pharmaceutical and biotech industries, including their suppliers. 

Mission Statement:
Millions of people around the world are treated every day with the vital medicines discovered and developed by the pharmaceutical and biotech industries. Management of the drug supply chain has become one of the top public health concerns with respect to consumer safety.

Problem Statement:
Globalization of distribution for both drug components and finished products has introduced many complications that challenge the security of the supply chain. These complications can provide opportunities for unethical players and noncompliant companies to introduce counterfeited, adulterated and contaminated materials, often with tragic consequences. 

This issue is highlighted by the following highly publicized incidents: 

1) Adulterated glycerin with diethylene glycol (antifreeze) used to manufacture cough syrup led to 67 deaths in Panama and 103 deaths in Haiti (mostly children).
2) Adulterated Heparin with hypersulfated chondroitin sulfate led to 81 deaths in the US and Europe.
3) Adulterated milk with melamine led to contaminated infant formula causing kidney stones and deaths of infants in China.
4) Adulterated glycerin with diethylene glycol used to manufacture teething gel led to over 40 infant deaths in Nigeria.
5) The World Health Organization (WHO) estimates that 10% of all medicines around the world are counterfeit. In addition it estimates that up to 25% of medicines sold in developing countries may be counterfeit, and some studies conclude that the percentage may be even higher.

Naturally, such incidents lead to a loud and swift reaction from the public, health authorities and policy makers. Legislators, regulators, and other organizations around the world are currently developing and implementing local measures to curtail these activities or mitigate their impact, but a global effort is needed to address this global issue.

Functions of Rx-360:
The consortium will have four distinct functions that can best be done collectively. 

The four functions are as follows:
1)  Adopting Standards and Best Practices: The consortium will scan external sources for the best available standards today that will assist in improving the performance of the supply chain.  The goal will be to prompt consortium members to adopt best practices with a sense of urgency.  After implementation, the consortium will look to identify any gaps in the standards, aimed at improving on these standards. 

2)  Technology Development: The consortium will work with research organizations, such as Massachusetts Institute of Technology (MIT), The National Institute for Pharmaceutical Technology and Education (NIPTE), and research institutions in Europe to develop new technologies that will secure the supply chain and to detect if there has been tampering with the supply chain.

3) Monitoring: The consortium will act as a clearing house for vital market and supplier and supply chain information.  Consortium members will report suspicious and pertinent events to the consortium, which will then disseminate the initial information, evaluate the impact of the information on its members and then develop potential proactive solutions for its members to consider adopting. 

4)  Shared Supplier Audits: The consortium will provide for a wide range of auditing services such as GMP, GDP, EHS and supply chain security.  The consortium will develop a system that will make audits broader and more thorough, and allow firms to share audit findings and corrective actions making the system more effective and efficient.  The concept will reduce the number of audits at a particular supplier and increase the effectiveness of the audits performed. 


Membership:
• Rx-360 is designed to be inclusive. Any biotech, pharmaceutical, generic manufacturer or their suppliers along with third party auditing firms who agree to the requirements in the membership agreement can be members.
• Observer status is granted to applicable regulatory bodies and appropriate professional organizations and trade organizations.


For more information, please visit www.Rx-360.org or contact us: chemicals@merckchem.co.uk

 

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