top of page

Are you keeping up with US Pharmaceutical Serialization and Traceability?

The producers, repackagers are on a well-directed route for lot-to-package degree pharmaceutical serialization and traceability. The forthcoming four decades will see a few substantial alterations, integration situations, and upgrades of all US FDA DSCSA (Drugs Supply Chain Security Act) compliance computer software. It helps build a more highly automated, bonded, seamless distribution chain. It'll be useful in automatic serialization, authentication according to a repository, and information obtained from the genuine electronic distribution chain.

Upcoming years will seek out technologies’ adoption. There'll be crucial urgency among US pharmaceutical companies to select a technology associate for additional compliance, integration, and direction. Conventional pharma companies can seem to source those demands cost-effectively. Established ones are always able to research building a much better cost-effective facility using a committed in-house center aligned with help from highly skilled contractors.

There ought to be a method of reports, evaluations, and re-verification to guarantee FDA Drug Track and Trace. It's highly a good idea to maintain a regularly upgraded secondary database. It needs to be keeping a consensus involving information flow. This helps the FDA keep and improve FDA monitor and track it via an electronic system.


Wholesalers have a massive responsibility and confirmation of transit information bundles, the reception, and assessing for many degrees. A wholesaler should make an effort and construct a committed in the home IoT-automation established warehousing system, which pops continuous data flows. Pharmaceutical serialization and traceability jobs with medication supplies and safety action are completely directed for empowering FDA monitor and follow. It will lessen the counterfeits, discharged, very low action drug introduction to the distribution chain.

It takes a dependable DSCSA compliance computer software that provides one option for pharma supply chain organizations and partners into one stage. US FDA enrolled wholesalers should be searching for serialization solutions to make sure they are compliant with current and future regulations.


The addition of automated IoT-based solutions will lower the individual intervention and chances of mistakes. Automation is forecasted to decrease the general idle period of medications, shelf-life is crucial. All repackagers and white tag service beneficiaries are needed for drug makers. Yet no drug whatsoever should be passed to the market without any serialization. Pharmaceutical serialization and traceability would die a sad death if medications made at other sellers' facilities don't get serialized and would in addition put the clients at risk. It's crucial before formally making any initial move into the distribution chain, that regulatory compliance be followed and understood.


Pharmaceutical serialization and traceability endeavors with drug supplies and safety act are entirely directed for enabling FDA track and follow. It will lessen the counterfeits, stolen drugs and low activity drug introduction to the supply chain. It needs a trusted DSCSA compliance program that brings one solution for pharma supply chain organizations and partners into a single stage.

All manufacturers should have a local copy of the database. This should be located at the manufacturer’s office. Also, should be verifiable with a decentralized database for printing all data related to the supply chain.

Upcoming years will find technology adoption becoming a part of the solution. There will be essential urgency among US pharmaceutical companies to pick a technology associate for more compliance, integration, and management.

Total supply chain

It needs to be verifiable using a principal database such as printing GTIN, sequential number, Volume number, expiry date, along with GS1 Data Matrix. It's highly a good idea to keep a regularly updated secondary database. It should be keeping a consensus involving data flow and the drug packages in transit. The last shuttle deliveries and end-logistics could be assigned with delivery-tracking and direction methods. All this info must be steered onto a big scale to the packing and labeling of different prescribed medications.

Professional tips for many pharma supply chain partners:

  • Consistently maintain and regularly upgrade consignment details.

  • Maintain a database backup.

  • Become an active partner to your distribution chain online platform.


There should be a system of checks, balances, and re-verification to guarantee FDA Drug Track and Trace. It's highly advisable to keep a frequently upgraded secondary database. It should be maintaining a consensus between data flow and medication bundles transit. Also having a second set of eyes always helps and contracting an expert to verify or manage your track and trace processes could be very beneficial. Pharmaceutical serialization and traceability eases FDA Drug Track and Trace. It will help the FDA keep and improve FDA track and trace it via an electronic system. It will be useful in automated serialization, authentication based on a barcode, and data received from the authentic electronic supply chain.

For more information on how Vanguard Vision can help you with your serialization and traceability processes, message us here:

21 views0 comments


bottom of page