How To Implement A Pharma Manufacturing Serialization Program

By Rob Wright

If you were charged with implementing a serialization program at a pharmaceutical manufacturing facility, what would be your bulleted approach to implementing, with timelines and specific recommendations for completion? This was a question posed to David Harty, a 20+ years IT solutions and software expert. Formerly with such well-known companies as VeriSign and Siemens, he is now the VP of Systech International (a packaging integration company). Here is Harty’s list of recommendations and timeline estimates required for pharmaceutical manufacturing serialization implementation.

• Full Functional Requirements and Architecture, while this is a significant task it will provide a framework for all other activities and reduce the total cost of implementation dramatically (1 – 3 months – based on size)
• First implemented pilot system (12 months on average)

• Enterprise serial number management
• Site-Level serial number management
• Line-Level serial number management
• Line-Level execution and exception handling
• Site-Level execution and exception handling
• Enterprise EPCIS (Electronic Product Code Information Service) data capture of critical events
• Rework, quality assurance (QA) sampling and damaged goods handling
• Warehouse outbound serialized shipments
• Returns processing of serialized products
• Bidirectional EDI (Electronic Data Interchange) data exchange with partners

• Enterprise applications and material strategy adjustments (3 – 6 months)

• Material master changes for packaging GTIN (Global Trade Item Number) levels
• Serialization identification for production orders (e.g. batch characteristic, material characteristic, etc.) to identify when to serialize and what format
• Invoicing and RMA (Return Material Authorization) processing using serialized data support
• Serialized inventory management
  • Put-away strategies
  • Picking strategies
  • Cycle Count
  • Reconciliation process
• Trading partner data exchange fully implemented with auditing
• Life cycle management of serialization data
• Business intelligence integration with EPCIS and local data stores

• Rollout of new lines and sites (1 month per site average; 1 month per line average)

Where To Go For More Information
What are some reliable sources for finding information and guidance on implementation of a serialization program? Michael Stewart, executive with PharmTech (a pharmaceutical supply chain consultancy), suggests to seek out peer groups on traceability and serialization, professional conferences, solution provider conversations, and GS1 resources. In addition, consider bringing in consulting firms for strategy development and project leadership, as well as to accelerate your own learning curve. David Harty, VP with Systech International, advises when searching the Internet for case studies and whitepapers to “Look for companies to be named or included in the piece to insure you are getting real-world lessons and not a sales pitch.”

Here are some other sources to increase your serialization knowledge base.

• The California State Board of Pharmacy E-Pedigree Law Information can be found at: http://www.pharmacy.ca.gov/about/e_pedigree_laws.shtml
• Specific questions not answered here can be directed to Virginia Herold, executive officer of the California State Board of Pharmacy, – email Virginia.herold@dca.ca.gov
• Global Track & Trace (GTT), a serialization support website, provides insight on news and workshops and can be found at: http://globaltrackandtrace.org/home
• The website RxTrace, explores the intersection between the pharmaceutical supply chain, track and trace technology, standards, and regulatory compliance and can be found here: http://www.rxtrace.com/
• Additional information, explanation, and applicable use for GS1 identifiers can be found at: http://www.gs1.org/