What is Product Serialization?
Product Serialization involves a complete system to Track and Trace the path of prescription drugs through the entire supply chain. Product Serialization could identify every product by a unique serial number in addition to the origin, shelf life and batch number. This could allow the product’s life cycle to be traced from production, through distribution, and finally to the end-user.
Why is Serialization Needed?
The global pharmaceuticals industry is in the middle of major changes with regulatory requirements to improve supply chain security and patient safety. By implementing serialization methods, counterfeiting can be reducing significantly. By Nov 2017, all drug manufacturers must begin serializing their products at the saleable unit and case level for the U.S. market.
US Government has passed law HR 113 – 3204 Title-II to strengthen supply chain and control forfeiting products enter thru supply chain.
Pharmaceutical manufacturers need to ensure they comply with serialization legislation around the world such as US, EU, China, India, Brazil, etc. This is important to help maintain or improve your market share, sales, profitability and long term sustainability as a company. The deadlines are approaching and pharmaceuticals companies need to start adopting this technology with a high priority.
What is required to be done for DQSA 2017 compliance?
All prescribed product saleable unit & homogenized case required to have unique identification with 2D barcode, GTIN, Lot & Expiry date printed on each unit.
How can ACH Engineering Inc help to comply the regulatory obligation?
ACH Engineering has acquired extensive experience in serialization field by working with multinational large scale pharmaceutical companies. ACH is recommending the following team structure to plan, manage & execute the serialization program.
- Project Engineering and Management using PMI principles
- Serialization Program Setup & Strategic planning considering global regulatory compliance
- Develop Project Rollout plan, Risk & Gap Assessment, Budgeting & Financial Planning, Cost optimization, and Initiate Change Control
- Provide guidance in developing of Validation Strategy & Master Validation Plan
- Management reporting, CMO coordination, IT Strategy development for L-3 / L-4 / L-5
- Support for Vendor Evaluation & Selection, Negotiation, Procurement, FAT, Commissioning, Qualification & Site level Coordination
- Packaging equipment modification for building human readable text & 2D barcode print, inspect & reject capabilities
- Site Level Preparation (Conduct artwork design changes and proof-reading, equipment/product balancing, coordinate line downtime/shutdown, resource management, warehouse management for old Vs new inventory etc.)
- OEM coordination for existing equipment engineering and upgradation for aggregation & non-aggregation scenario
- Establish future state & requirements
- System (Vendor) Evaluation, Selection & Implementation
- Supply Chain Strategy Design and End to End Process Optimization
To achieve the project success, ACH Engineering takes strategic approach for managing any size of capital project. Serialization project overall scope divided in various stages to plan & execute the whole project in achievable milestone.