- 1. DOWNLOAD WHITEPAPER
DSCSA was signed into law on 11/27/2013, containing multiple deadlines of new regulatory requirements that get progressively more complex and difficult as time passes. The first deadline was January 1, 2015, requiring:
- All companies in the pharmaceutical supply chain to do business with authorized trading partners
- All companies, except dispensers, to perform “product tracing” containing TI/TH/TS, also known as 3Ts
- All companies to have a system in place to perform lot verification and suspect product handling
- All companies to respond to requests for information from state or federal officials within 24 to 48 hours
The next deadline is Nov. 27, 2017, requiring:
- 2D Datamatrix on packages, 2D or linear on cases by Nov. 27, 2017 (2018 for repackagers)
- Barcodes encode: NDC, Unique SN, Lot #, expiration date
- NDC+Serial Number “verification” by Mfr. & Repackager
- Packaging records must be retrievable for six years
- GS1 barcode & identifier standards will satisfy the law
- 2. INITIATE THE PROJECT
Serialization project has multiple touch points with many operations. It will span a significant length of time and involve many people. It is important to have a designated executive as the project champion and a project manager as the go-to person who drives the project. A strong leadership improves efficiency as it minimizes the amount of “communication overhead”. Instead of communicating to gain consensus horizontally, vertically, or on a dotted line, team members receive direct and clear communications from the leaders so they can focus on moving the project forward.
Contact LSPediA to initiate your serialization project.
- 3. GAP ANALYSIS
The gap analysis is a health check that identifies your stage of progress and the remaining gaps. It focuses on the critical business impact and defines the overall business requirements. It is an important step to sort out the complexity and then devise a workable scheme to accomplish the goal.
Engage LSPediA For Gap Analysis.
- 4. DSCSA TRAINING
The sheer complexity of the project can be overwhelming to companiess as they face the significant changes in systems, processes, and SOPs. Employees traditionally responsible for departmental duties are now required to work cross functionally. Proper training is necessary to help employees gain the knowledge and skills they need to understand the comprehensive requirements, their departmental responsibilities, and the integration of technologies and processes.
Call LSPediA For Training.
- 5. PILOT PROGRAM
A slight deviation of system design can lead to multitude of implications in a live serialized production environment negatively impacting the bottom line. Running a pilot program before production is high recommended. Pilot phase focuses on hands-on experiments to test design and validate processes. It allows the team to identify flaws, iron out issues, and correct problems before scaling it to production.
Call LSPediA To Start Pilot.
- 6. PRODUCTION PROGRAM
Once tested, refined, and validated, the pilot is ready to go production. Going production has its own curve balls. Things that worked in pilot may deviate in production. You may find things that you have not encountered in Pilot. Systems and equipment running in a high speed environment may need constant tuning. Exceptions that did not surface during pilot may now stop production.
Our experienced consultants will guide you to the most effective approach to Serialization Production.
- 7. MANAGE THE PROJECT
A costly mistake of running a project is starting with incomplete requirement. This will often lead to project failure, mid project scope creep, project over run, and project over due.
Proper project management is critical to the success of the DSCSA Serialization implementation. Divide the project into phases and then create a solid plan for each phase will make it easier to manage. Allocating resources, managing schedules, and reporting status are necessary to keep the project on track.
LSPediA offers comprehensive project management services.
- 8. GET UPDATES
Keep up with changes by updating your requirements and plans regularly. The serialization processes and practices are far from maturing. Standards and regulations are still emerging at the state, federal, and international level. Identify any changes and analyze their impact on your business first. Keep tabs on the critical impacts and realign your plans accordingly to avoid the risk of missing an important requirement or delivering an incomplete solution.
- 9. SHARE THIS GUIDE
Share this guide with your team members as a conversation starter or the discussion point. Identify the areas you need help. Send us an email or call us at (248) 973-2008 for questions, training needs, or consulting opportunities. We are thankful for your consideration and truly appreciate your business.