pharmaceutical product serialization and dqsa
DESCRIPTION
Serialization, the process of assigning and marketing each individual pharmaceutical product or component with unique markers provides a comprehensive history of the product’s chain of custody from manufacturing through to drug dispensation. Using serialization enables improved collection, traceability and security of pharmaceutical products throughout the supply chain. Currently over 50% of the pharmaceutical industry uses serialization with coding and marking technology implemented during the manufacturing process but is less commonly used by co-packers and smaller pharmaceutical companies. Using product serialization for pharmaceuticals is beneficial in a variety of ways. Serialization helps to control costs, improve shipping accuracy, facilitate better control of inventory, and minimize product chargebacks associated with packaging errors. Serialization of pharmaceutical products helps ensure compliance with federal regulations. In addition, pharmaceutical product serialization helps to protect against counterfeiting to ensure consumer product safety and help to safeguard brand reputation. Serialization is a key component of the new Drug Quality and Security Act (DQSA). The Drug Quality and Security Act ensures that one consistent regulation is applied across all states. The new law will help to eliminate threats to patient safety and security and will aid in improving the effectiveness of product recalls. By the end of 2017, full serialization on a package level for pharmaceutical products is required. Pharmaceutical manufacturers must place a unique serial number on individual packages of prescription drugs to facilitate product tracing and authentication from the point of manufacturing through to dispensation. Over the next ten years, the Drug Quality and Security Act mandates the following key provisions for implementation: third party logistics provider licensing; product identification, product tracing; product verification; wholesale licensing; notification; detection and response.TRANSCRIPT
Pharmaceutical Product Serialization and DQSA
By Laura Olson
Why Product Serialization for Pharmaceuticals
• Provides complete history of a product’s chain of custody from manufacturing through dispensation
• Helps to increase the level of security in the pharmaceutical supply chain
• Enables better collection, track and trace of pharmaceutical products throughout the supply chain
What is Serialization?
• Serialization is the process of assigning and marking each individual product or component with unique identifiers
• Serialization code can be as detailed as required by a customer
• Serialization codes may include Global Trade Identification Number (GTIN), product or drug description, stock-keeping unit (SKU), batch or lot number, expiration date, production date, manufacturing line and facility in which product was produced
• Some serialization solutions include application identifiers (AIs) for increased flexibility
Adoption of Serialization
• Today over 50% of the pharmaceutical industry is using serialization with coding and marking technology implemented in the manufacturing process
• Serialization is often not used by smaller pharmaceutical companies and co-packers
• Biggest area of concern in adopting serialization is the infrastructure required to support it
Benefits of Serialization
• Compliance with federal regulations
• Helps to ensure consumer product safety and protect against counterfeiting
• Helps to protect brand reputation
• Facilitates improvements in efficiency
• Helps to control costs and improve shipping accuracy • Improves effectiveness and efficiency of product recalls
• Facilitates better control of inventory
• Helps minimize product chargebacks associated with packaging errors
• Helps manufacturers control pricing & how chargebacks are executed
What is DQSA and Why is This Needed
Signed into law on November 27, 2013, the Drug Quality and Security Act (DQSA) outlines the steps to build an electronic, interoperable system to identify and trace specific prescription drugs as they are distributed in the US Key provisions for implementation over the next 10 years: • Product identification • Product tracing • Product verification • Detection and response • Notification • Wholesale licensing • Third party logistics provider licensing
Developed to ensure a consistent response from all states to eliminate threats to security and patient safety and improve the effectiveness of product recalls
Serialization and DQSA
• By the end of 2017, full serialization on a package level is required
• “Product identifier” is required and must include the National Drug Code, standardized numerical identifier, lot number, product expiration date
• Pharma manufacturers are required to place a unique serial number on individual packages of prescription drugs to enable authentication and product tracing from manufacturer to dispenser
• DQSA regulation provides a single nationwide system that requires participation across all supply chain sectors
The DQSA Mandated Product Identifier Explained
00100011234013
124511236711
12 2015
A12435X
GTIN Serial Number Expiration Date Lot Number
What is a Product identifier? Standardized graphic that includes in both human-readable form and on a machine-readable data carrier: • Standardized numerical identifier (set of numbers or characters used to
uniquely identify each package or homogeneous case that is composed of the National Drug Code (NDC) plus a unique alphanumeric serial number of up to 20 characters
• Lot number • Expiration date of the product
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