Anti-counterfeiting Compliance & Solutions
On April 25, 2013, Janet Woodcock, Director, FDA CDER reiterated the FDA’s stance on “the increasingly complex drug supply chain, from raw source materials to finished products for consumers, presents multiple opportunities for the product to be contaminated, diverted, or otherwise adulterated”.
Alpha Compliance provides the Life Sciences Industry 12 years expertise and solutions to meet applicable legislations, standards, and regulations.
Track & Trace Systems.
Implementation of a system to fully track and trace prescription drugs throughout the supply chain would help in combating incidents like the counterfeit Botox example from a few weeks ago. Although the Food and Drug Administration Amendments Act of 2007 (FDAAA) does grant FDA authority to set standards for identification, validation, authentication, and tracking and tracing of prescription drugs, there currently is no enforced requirement of a national track-and- trace system throughout the drug supply chain in the USA.
However, California plans implementation for 2015 and other states are sure to follow soon thereafter. Europe has implementation plans in 2013.
Serialization / e-Pedigree.
Counterfeit drugs carry unknown ingredients and handling leading unknown safety and effectiveness. Counterfeit drugs raise a significant global public health concern.
In 2003, over $20 million in illegally imported and counterfeit Lipitor (atorvastatin calcium), was distributed throughout the United States. The source and manufacturing methods of the product were unknown and had the potential to endanger patients. [Source: FDA website]
Alpha Automation was started to provide customers options for the integration, verification, and compliance to upcoming or established legislations, guidance, and customer requirements surrounding the implementation of track and trace software and serialization systems. Integration among systems (MES, ERP, local and other database systems) is key for supporting the security of the supply chain. Alpha Compliance Services will implement compliant systems and procedures using experts in the fields of automation and regulatory compliance.