Jay will discuss UDI implementation at MDMA FDA Forum on March 11
Moving to the Cloud can be an easy choice for regulated Life Science companies. USDM's Cloud VAP offers a subscription compliance model.
USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary for compliance with pharmaceutical serialization (track and trace) regulations, including the Drug Quality and Security Act (DQSA). Our team of experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made.
USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.
Ultimately, USDM will ensure a timely, efficient and smooth transition to the new regulations and do so in a controlled, documented process that ensures success, cost effective compliance with the regulations and continuity of production for critical products.
Pharmaceutical companies need to develop a strategy to conform to the new rules, implement changes and validate them. For some companies, adapting to new government regulations is a daunting task that often takes years to complete. Some of the world’s largest pharmaceutical companies have hundreds of drug products when dosage and package counts are included.
Pharmaceutical companies will benefit from a track and trace system in the same ways as the medical device industry will benefit from a unique device identification system, but a track and trace system has additional benefits for the pharmaceutical industry. Track and trace systems will hopefully stop a growing problem for drug companies. The number of reported cases of counterfeit medicines is on the rise. Counterfeit drugs are being found in developing and developed countries worldwide. Drugs in high demand with a high cost are the most targeted. In many cases, the drugs do not have their intended ingredients in them. Patients who unknowingly obtain and use the counterfeit drugs are not getting the medical treatment they need and many unsuspecting patients are dying from the counterfeit medicines. The World Health Organization estimates that counterfeit drugs make up less than one percent of medications sold in developed countries, but between 10 percent and 30 percent in emerging markets. Drug manufacturers can be held liable for the illnesses and deaths the counterfeit drugs cause, unless they can prove the drugs are counterfeit. Many lawmakers worldwide believe an electronic tracking system will put an end to the counterfeit drug market.