Supply Chain Compliance Services

The pharmaceutical supply chain is complex and involves many players. Breaks in the pharmaceutical supply chain pose risks to both the pharmaceutical industry as well as patients. Thousands of people worldwide die every year from ingesting “fake” drugs. This costs the pharmaceutical industry an estimated $46 billion a year in lost profits.

Several states are now mandating that companies confirm the authenticity of their product by creating a pedigree that vouches for a drug's origin and who else has handled it. The FDA has recommended that pharmaceutical companies start using radio frequency identification technology (RFID) as a means of better tracking drugs. As a result, most pharmaceutical companies are experimenting with RFID, or at least using bar codes or other technologies such as web portals that can help track and authenticate the drugs.

Beginning with California and its January 1, 2009 deadline, states are moving to mandate the serialization and tracking of all pharmaceuticals moving in within its borders. California has mandated that prescription drug packaging, starting at the unit-of-sale level, must be marked with unique serial numbers. Furthermore, it requires that an electronic pedigree for pharmaceutical packages be created by the manufacturer then maintained and communicated throughout the supply chain to the retail level.

Many pharmaceutical, medical device, and biotech companies rely on third parties as part of their supply chain. That is why it is imperative that manufacturers have a sound supply chain vendor management program in place.

CompliaPharm assists clients with supply chain compliance through the following services:

Development of policies and SOPs
Cold Chain guidance
- Program assessment and development
- Qualification of shipping containers
- Assessment of holding facilities
- Process mapping and process development
Pedigree program guidance
Qualification and/or auditing of third party logistics providers
Recall guidance