Low Cost Compliance with DSCSA Serialization Requirements for Small Batch Pharmaceutical Drug Manufacturers
When we think about pharmaceutical manufacturing and packaging, I think we have this perception that the “big pharmaceutical companies” have deep resources, tremendous infrastructure and have all the resources in the world to comply with FDA regulations, new GS1 standards and DSCSA requirements. Indeed, they do – but did you know that there are thousands of small batch pharmaceutical drug manufacturers who put together pre-dosed weekly and daily medication packs for hospitals, clinics, nursing homes and other healthcare facilities?
Helpful Info For Specialty and Small Pharma Packagers
(excerpt from Bell Hawk’s: Low Cost Compliance with DSCSA Serialization Requirements for Small Batch Pharmaceutical Manufacturers – published March 2018)
As of November 2017 (with a one year grace period for implementation) all manufacturers of pharmaceutical drugs are required to put a 2D serial number identification barcode on each bottle, tube, bag, and box containing FDA regulated products. This is part of a set of regulations that the FDA is issuing for compliance with the DSCSA (Drug Supply Chain Security Act). This is being expanded to repackagers in 2018 and to Distributors with the aim of having complete end-to-end supply chain traceability by 2023.
The serialization barcode is a 2D Datamatrix barcode containing the GTIN (Global Trade Identification Number) for the product, a product serial number, the lot number, and expiration date. Manufacturers are also required to track the serial numbers of the products they ship along with the GS1 SSCC (serialized shipping container code) for each level of nested container (carton, pallet) into which they are packed.
For large manufacturers, that have fully automated production lines, the automated labeling of products and their packaging, as well as recording of the serialization data is performed by fully automated production lines, which can cost a million dollars or more apiece. For pharmaceutical manufacturers who specialize in small batches, made to order, such costs are not affordable, either in acquisition costs or the time to setup each line. Cloud-based solutions are often the solution for small packagers.
There are affordable materials tracking and traceability software solutions available that capture and store the serialization data needed to be able to rapidly check whether the products are counterfeit. This software can then relay the serialization data to supply chain partners as well as uploading this data automatically to online repositories that provide counterfeit checking capabilities.
Simple Low Cost System for Small Runs
The simplest possible system, for small runs, starts with rolls of product labels that are pre-printed with the serialization barcode and needed preprinted product information in human readable form. This solution also starts with preprinted rolls of SSCC barcodes (link to which product here, Dana?) for cartons and products. As each container of product is made a product label is attached. Then, as a batch of products are packed into a carton, an SSCC barcode is attached to the outside of the carton. This is followed by scanning the 2D barcode on each product with a handheld or hands-free barcode scanner as it is placed in the box. Then the SSCC barcode on the box is scanned to record which products went into which carton.
This can all be accomplished through the use of preprinted rolls of product and SSCC barcodes and some inexpensive barcode scanners. The preprinted rolls are available on a quick-turnaround basis from PaladinID, as is the barcode scanning equipment. The barcode scanner will scan the product barcode as it is passed in front of the scanner or vice versa.
Preprinted Rolls of Barcodes
High volume lines use inkjet or other technologies to automatically label each product container as it passes down the line. Such systems are expensive to acquire and require careful setup to get the barcode labeling to work so as to print high quality product barcodes.
Preprinted rolls of DSCSA compliant barcodes, are inexpensive and are ideal for small batches. However, they require tracking the labels to make sure that a product serial number is not duplicated.
PaladinID provides serialized preprinted labels.
Manufacturers can elect to preprint their own labels using a barcode label printer and a label printing program. PaladinID offers on-site and remote assessments to ensure that the manufacturer is selecting the appropriate printer and label software for their particular needs.
Please contact Dana Ritchie ([email protected] or (603) 527-0256) for more information on setting up a barcode label printer in your facility OR for pre-printed barcode labels.
About Bell Hawk
BellHawk Systems provides its BellHawk real-time inventory and operations tracking software to manufacturers, distributors, food processors, laboratories, engineering, small batch pharmaceutical drug manufacturers and other industrial organizations. It also provides related professional services to assist its clients in implementing these systems as well as in integrating these tracking solutions with their ERP, CRM, accounting, E-Commerce and other systems.
About PaladinID, LLC
PaladinID develops and supports high-performance bar code labeling applications. We work with our clients to “Make Your Mark” by providing the expertise and tools necessary to create an entire product label printing solution. Located in central New Hampshire, PaladinID has been serving Massachusetts, Vermont, Maine, Connecticut, Rhode Island, New England, and beyond for over 30 years, and in 2017, became an RFID-certified company.