The accuracy of serialization data and compliance by trading partners provides the foundation for compliance with the Drug Supply Chain Security Act (DSCSA). During the pharmaceutical packaging process, however, there may be unplanned events that jeopardize the integrity of the data, reduce productivity and increase operational costs.
Equipment jams, power failures, product damage during handling and operator errors will happen. Additionally, a product that is processed without incident may need to be removed from a pallet for periodic QA sampling. All of these events impact the many serialization-related requirements with which pharmaceutical manufacturers, repackagers and Contract Manufacturing Organizations (CMOs) must now adhere.
Factors that necessitate that packaging be reworked, and like many choices in life, you can either do it the hard (costly) way or the easy (productive) way. Here are some tips to consider when seeking a repacking solution to help ease the packaging rework process.
Address unique packaging configurations
Some single material handling solutions do not account for all the variables experienced during the serialization process. For this reason, it is crucial for companies to partner with providers who are interested in and have the engineering expertise to work with your internal teams to customize repackaging solutions based on your unique packaging configurations.
Ability to work with nonproprietary equipment
Now repackaging solutions are available that will connect to any major brand printers, vision systems and barcode scanners. As a result, companies are no longer forced to use proprietary equipment that can be difficult and costly to integrate.
Flexibility to work with multiple products and packaging configurations
The primary function of repackaging solutions and software is to enable the ability to decommission product and remove samples. However, the solution should also efficiently operate within an environment with multiple products, managing data with varying packaging configurations, and has the flexibility to create partial cases or pallets.
Intuitive platforms with reporting capabilities
Some solutions are more intuitive than others. Look for platforms with programming that require the appropriate number of ‘children’ (items) are scanned before a ‘parent’-level label is printed for the case or pallet. This capability will significantly reduce the opportunity for human error in semi-automated solutions.
This type of packaging rework will require new serialized labels for each packaging level per GS1 and HDA requirements. It is also critical that once the amended aggregation information is entered and completed, the system can reprint the serialized case and pallet labels. Orders that are reworked or relabeled should also have complete reporting that documents all changes made during the serialization process.
Agile systems for product and packaging manipulation
Thus, when it becomes time to find or switch to a new serialization partner, keep in mind all the operational processes necessary to comply with the myriad of DSCSA and quality requirements. The partner you are considering should have agile systems and have already considered the rework of aggregated product. In addition, the solution functionality should make manipulating the product, packaging and data streamlined and effortless for your operations.
With the proper repackaging solution, pharmaceutical manufacturers can simplify their rework process and reduce production downtime.
Terrence O’Neill serves as director of new product development at Covectra, a leader in track and trace solutions.