Will you be able to ship your products on November 27, 2018?
Starting November 27, 2018, prescription drug products can no longer be shipped without a DSCSA-required serialization identification code.
“Pharmaceutical manufacturers are required to print a unique product identification code on all Rx units of sale and homogeneous cases distributed domestically.” – DSCSA, FDA
As the Drug Supply Chain Security Act (DSCSA) deadline quickly approaches, you should have a clear serialization strategy for compliance in place.
Pharmaceutical Serialization: An Implementation Guide
1. Planning stage
Do you have a solid plan for the implementation of serialization? When developing a plan, consider your pharmaceutical product’s current state and what must be done to meet compliance.
Manage master data preparation work and ensure that you have all production information needed on hand (e.g. National Drug Codes, product descriptions, Global Trade Number for each packaging level).
2. Solution design stage
The DSCSA GS1 Guidelines have specified several serial number formats for you to choose from. In addition, pharma companies have the option to generate serial numbers themselves or assign this task to their contract manufacturing organizations (CMOs). Consider all of the options and pick the serial number generation and format option that works best for your pharmaceutical product.
In order to comply with the DSCSA guidelines, you may be forced to alter your pharmaceutical product’s artwork. Redesign your product labels to accommodate the 2D Data Matrix Code.
3. Build a pilot stage
Test your serialization strategy by building a pilot program to learn how your large-scale serialization project might work in practice. Complete a test run with every CMO partner to determine if you can successfully send serial numbers to each other.
4. Deployment
Put your serialization plan into action and launch production to track and trace your pharmaceutical products with a designated project manager responsible for your serialization and traceability program.
5. Long-term maintenance
Long-term maintenance of your serialization program will be an ongoing process and may involve updating, adapting, and modifying your program for regulation changes, new technologies, new markets, and more. Continually monitor your serialization program to ensure compliance with regulations and avoid defaults, returns, or inspections.
A delay in serialization is no longer an option for pharmaceutical products. Avoid struggling to acquire serialization equipment, delivery delays, and other issues that may arise by partnering with a packaging solutions provider with serialization expertise. Contact Bellwyck Pharma Services today: https://bit.ly/2sUnyf4.
