Questions to ask your CMO/CPO about serialization

While the focus of many pharmaceutical manufacturers is on their own internal infrastructure, it’s prudent for manufacturers to begin surveying their contract manufacturing and contract packaging organizations for serialization readiness.

Below are a few questions to ask:

• Have you developed a strategy for serializing product? If so, what is your go-live date?
• What is your plan for managing serialized data (provisioning, exchanging, receiving, sending, storing)?
• How are exceptions handled?
• Do you have the ability to handle both serialized and non-serialized product?
• What contingencies do you have in place to ensure that there will be no disruption in production of my products due to complying with serialization mandates in a timely manner?
• What printing technology or technologies are utilized? (i.e., impact printers, thermal printers, laser printers, ink-jet printers, etc.)
• Do you have the ability to print GS1 Standard barcode symbols (GS1 128, GS1 DataBar, GS1 2D DataMatrix, etc.) that meet minimum print quality requirements?
• Do you have the capability to verify/scan GS1 format barcode symbols?
• Can you grade the barcodes to ensure readability in the supply chain?
• Do you have the capability to receive a range of serial numbers from our system?  (Separate from your other clients?)
• If yes, describe the communication methods supported (direct integration/web services vs. manual e-mail/text file/spreadsheet).
• Do you use Electronic Data Interchange (EDI) Advanced Shipping Notices (ASN) today, and have you considered it for sharing serialization information?
• Do you have the capability to communicate serialization event data to external systems?  If so, in what format (e.g., flat file, XML, EPCIS)?

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