Are you on Track (and Trace) to meet your Serialization deadlines?
The Serialization team at ASI knows how important it is to prepare for the Drug Supply Chain Security Act (DSCSA). The purpose of the DSCSA was to create a comprehensive electronic system to “track” and “trace” the passage prescription drugs through the supply chain in the United States, as of Nov 24, 2017. FDA link here>>
This is being accomplished with Serialization. By applying a Unique Identifier to the lowest sellable, unit, and aggregating the “child” units into “parents”. Sounds simple, right? Preparing for Serialization requires a lot of time and execution of a plan.
We can take your Serialization projects from start to finish, just like we did for one of our major Pharmaceutical Manufacturing clients who chose our support for their novel packaging needs.
- 15 packaging lines: 3 manual and 12 robotic
- Each needed Serialization software and equipment installed
- 47 Product codes needed Serialization implemented across 15 lines
- All Automated Label Applicator (ALA) cells also were replaced/upgraded
From well thought out plans, final reports and more, ASI was able to provide Quality Engineering, Project Management, technical trouble shooting, and operator training to make this project successful. We built “offline” set ups to allow for all necessary testing of the equipment at the vendor’s site in order to minimize downtime while maximizing the quality of the service we provide to the client.
Once troubleshooting was completed Factory Acceptance Testing (FAT) and 90% of the Installation Qualification (IQ) and Operational Qualification (OQ) was performed at the vendor’s site. Only 10% of the qualification had to be performed on-line at the client’s facility, followed by 3 PQ batches.
Talk to us about your Serialization needs, how can we help you?