In 2006, the Food and Drug Administration enacted the Compliance Policy Guide for the Prescription Drug Marketing Act. The policy implemented serialization and e pedigree in the pharmaceutical supply chain to protect consumers from counterfeit or contaminated drugs that could harm them.
E pedigree in the pharmaceutical supply chain is the documentation of each step in the process of manufacturing pharmaceuticals. The term “track and trace serialisation” refers to the bar code that records each step in the manufacturing process, from its creation, to packaging services, and shipping. Every step is recorded and audited, to ensure utmost safety for patients.
Impact of e Pedigree in the Pharmaceutical Supply Chain
Some of the benefits that have been realized since the passing of the Compliance Policy Guide for the Prescription Drug Marketing Act include:
- Standardization. All pharmaceutical manufacturers having to follow the same compliance guidelines ensures that all consumers can have the same level of confidence that their medication is not counterfeit or tampered with, regardless of where they get it. It also makes weaknesses in the manufacturing process more identifiable, as all manufacturers follow the same standards and deviation is obvious.
- Reduced liability. The track and trace system authenticates the medication being handed to the patient from beginning to end. This protects the manufacturers, pharmaceutical packaging companies, and retail dispensers from misconduct allegations. Not to mention, it serves the original goal of protecting the consumers.
- Improved efficiency and reduced costs. The automation of track and trace systems makes previously manual processes more efficient. The entire pharmaceutical supply chain moves smoother: creation, shipping, packaging, repackaging for the end user, receiving, and returning. Additionally, pharmecutical companies save costs by avoiding potential recalls.
- Efficient inventory and reduced returns. It is estimated that as much as 5% of pharmaceuticals get returned due to poor inventory practices. The automated system of inventory that track and trace serialisation provides reduces human error in inventories.
Finding an e Pedigree System
Companies within the pharmaceutical industry should look for a track and trace system that has the following features:
- Compatibility. The track and trace system should be standards-based so that it meets FDA requirements, as well as being compatible with other pharmaceutical systems that are used to manage the process.
- Reporting. A track and trace system should be constantly updated as new e Pedigree requirements are put in place. Any new standards should be verifiable through a reporting mechanism.
- Flexibility. Depending on the state, there are varying standards that have to be met. Some states require all pharmaceutical data to be captured and managed with bar codes, others require radio frequency identification. The compliance standards frequently change. A good track and trace system should be flexible to comply with changes and difference requirements between states.
What e Pedigree track and trace system does your company use? What are the greatest benefits of it? What do you wish was different about your track and trace system? We would like to here your feedback in the comment section below.