Serialization in pharmaceuticals playing a vital role in securing product information, counterfeit and falsified medicine that cause world public health at risk. These medicines are also not only ineffective however actively dangerous, inflicting adverse reactions or even death. What is more, these counterfeit medicines are also factory-made in multiple locations, e.g., chemical synthesis in one country, the addition of fillers during another, and packaging in third sites creating them tough to trace and deduct from the supply chain?
So to reduce the proliferation of counterfeit medication within the U.S., the Drug Quality and Security Act (DQSA) was signed into law in November 2013. Title II of DQSA outlines steps to make the associated electronic system spot and trace prescribed drugs as they’re factory-made and distributed. These rules apply to makers, repackagers, wholesale distributors, dispensers, and third-party supplying suppliers.
Here are many basics to assist you in understanding the relevant regulatory problems and, therefore, the serialization method.
Serialization in pharmaceutical, What it does:
Serialization in pharmaceuticals involves tracing the product’s origin, Batch details, like the Batch number and Expiration date via the unique serial number from the manufacturer to consumers.
The manufacturer will produce a serial number for products and apply on different batches via printing on labels and carton with barcode system. The manufacturer keeps all the records of these serial numbers for every batch after the manufacturing or packing of a product.
The units will then be tracked through its entire provide chain — from production to retail distribution to the ultimate dispensation to the patient. The DQSA mandates that every one pharmaceutical sold within the U.S. should be serialized at each marketable unit level.
Serialization process flow:
The Food and Drug Administration guidelines recommend the employment of standard numerical identifiers (SNRIs); during this, the serialized national drug code (sNDC), which is the NDC combined with a singular serial range. the entire process of Serialization in pharma has involve following stage:
- First processing randomly and subsequently of serialization code, the manufacturers print 2D Barcode on each label generates during the process.
- Each label scans to determine which small unit goes into which final packed because the lower unit is not visible(e.g., first carton print with 2D barcode than after scan goes to which shipper) and a number of shipper in each pallet.
- It is speculated by massive distributors that the Food and Drug Administration will shortly need the gathering of serialization data and verification that serial numbers were in every bundle, shipper, and pallet, and ultimately that units were sent to every distributor.
- So as to possess this info without reopening each shipping case, it needed that the maker aggregates the data throughout the method.
- This data can then be sent electronically in an associate advance shipping notice (ASN). All parties should retain the data for the Food and Drug Administration audits.
- By 2023, Pharmaceutical company manufacturers should also implement an associated electronic system capable of tracing all packages of pharmaceuticals through the complete distribution chain.
Key challenges in Serialization:
Serialization in pharmaceutical causes different problems at different levels during the pharmaceutical manufacturing process:
- Redesign of packaging: Many manufacturers face this problem because manufacturers need to redesign labels significantly leads to redesign also of packaging structure and elements.
- Reduce in production efficiency: Due to its complected and long process like labels printing, scanning at every stage will slow down the packaging line. So to compensate, the manufacturer needs to require more manpower.
- Data storage: Data storage and its generation, storage, and capture of lots of serial numbers are a key challenge for the IT department.
- Lack of trained personnel: The serialization process required a well-trained team likes experts from IT, processing/ maintenance, packaging, and QA to operate a smooth operation.
- Cost: Serialization requires more expenditures to operate, renew or update existing machinery, software, and hardware.
Read Also: ICH Guidelines in Pharmaceutical
serialization is the unique identification number assigned on each individual packs of cartons and bottles, a globally unique number is assigned to each batch of finished products in the form of a two-dimensional code know as Datamatrix.
The track system is easy to understand the location of any product items and Trace is to understand the history of products that come in contact with the item in the suppling chain.
Track and trace system is able to determine the current and past location of unique items, in response to an increase in the number of recall products from market the track and trace system is employed in the pharmaceutical, it is good in traceability through radio frequency identification and barcode.
RFID is radio frequency identification is a new technic. its a part of supply chain management in international pharmaceutical production and distribution. RFID is employed to counterfeit the drug products which are highly challenging for the government, a pharmaceutical company, clinical, and to patients.