Counterfeit and falsified drugs are becoming a top risk for public health and safety in the pharmaceutical industry. In addition to posing threats such as unfavorable reactions, counterfeit drugs can furthermore prove ineffective, harmful, and in some cases, fatal. Additionally, counterfeit drugs are often manufactured in multiple locations – breaking consistency in crucial stages of development including chemical synthesis, filler adding, and packaging. This makes these medicines difficult to track, and hard to remove from the supply chain.
To decrease the production of counterfeit drugs in the United States, the government signed the Drug Supply Chain Security Act (DSCSA) into law. The DSCSA requires that every prescription drug package and homogeneous case have its unique identifier in a machine and human-readable forms. These regulations apply to manufacturers, re-packagers, wholesale distributors, dispensers, and third-party logistics providers.
Here are a few basics to help you understand the significance of serialization.
What is Serialization?
Serialization is the assigning of a unique serial number to each saleable unit of every prescription product, which tells us the product’s origin, and other information in the form of a 2D Datamatrix barcode, including:
- Serial Number
- National Drug Code
- Batch number
- Expiration date
This also serves as the units’ tracking system through the entire supply chain – from production, through distribution, to the final dispensation to the patient.
The Serialization Process
Meeting DSCSA requirements can be challenging for many pharmaceutical companies. It is recommended by the FDA to use standard numerical identifiers (SNIs). Specifically, the serialized national drug code (sNDC), which combines a unique serial number with the National Drug Code (NDC). To develop these identifiers, many pharmaceutical companies turn to pharmaceutical packaging professionals.
To delegate which case a unit will go into, the production line scans each label individually. Each bottle is equipped with a temporary UV ink label on the bottle’s lid to account for the hidden label while bottles are top-loaded.
It is predicted that the collection of serialization data and verification will soon be required by the FDA. This would help immensely in the tracking of serial numbers from bundle, case, to pallet, as well as tracking which units are sent to each customer. Aggregating data throughout the production process would allow manufacturers to have this data without the need to reopen packages. Additionally, all parties must retain the information for FDA audits and inspections. Two types of inspections to plan for are FATs and SATs.
Factory Acceptance Tests (FATs) are inspections that include testing, both static and dynamic, of systems or major system components to support the qualification of a serialization system.
The tests must verify that all functionality embodies and performs at a standard detailed in the User Requirements Specification (URS). It is usually written by manufacturers and executed by the client or client representative.
Site Acceptance Tests (SATs), similarly to the FAT, also entail inspection and dynamic testing of systems or major system components to support the qualification of the serialization solution. This is written by the client and verifies that the installed functionality of the equipment operates at or above proficient in requirements specified in the equipment URS. The SAT is executed on the proper completion of all commissioning tasks; and before the start of “go-live” execution.
An appropriate amount of time must be allotted to proficiently performing FAT and SAT validations, and ensuring serialization implementation meets compliant standards.
Challenges in Serialization
Serialization presents challenges at many different points in pharmaceutical manufacturing.
- Label redesign – To properly apply the 2D Datamatrix barcode, manufacturers may have to significantly redesign labels. This may also require a redesigning of packaging structure or graphic elements.
- Production efficiency – In order to maintain elite production levels, manufacturers will have to increase manpower or automation to meet labeling and production requirements moving efficiently. This will ultimately impact multiple processes in the supply chain.
- Data management – Data management needs will grow rapidly, in addition to physical packaging adjustments. Generating, storing, capturing, and transmitting millions of serial numbers for numerous supply chains must all be accomplished by the IT design.
- Assembling a cross-functional team – With serialization involving both information and production aspects, it will require multiple departments working together to maintain proper efficiency. Department elites from production, IT, labeling, engineering, quality assurance, kitting, and management must collaborate to achieve a common goal.
- Costs – While necessary and extremely helpful, serialization will require a sizable capital investment in order to cover start-up expenses. This includes buying new machines, updating existing hardware and software, and training the staff. These expenses, while significant, are necessary to ensure proper efficiency and follow a compliant serialization process.
How Serialization Helps You
To address the challenges head-on, pharmaceutical companies can partner with packaging experts to develop efficient and compliant serialization solutions that meet their production goals. When fully implemented, serialization leads to increased transparency, reduces counterfeiting, and deters diversion and theft. With the additional ability to trace product locations, supply chain partners can increase shipping accuracy and more efficiently and accurately remove recalled and defective products – this, in turn may result in saving companies a substantial amount of money.