Serialization in Pharma Packaging & Labelling

The practice of accurately identifying and monitoring individual pharmaceutical product units or batches across the supply chain is known as a serialization in the packaging and labelling industry. This includes details regarding the product's batch number, validity, and expiration date. For the purpose of patient safety and regulatory compliance, it is imperative that the integrity, authenticity, and traceability of medications be guaranteed. As part of the serialization process, each unit or batch is given a unique serial number or code; typically, this data is encoded in an RFID tag or 2D barcode. International forums such as the World BI Conferences on Pharma Packaging provide professionals with invaluable opportunities to remain current with the latest developments in their field, exchange knowledge, and collaborate on innovative solutions aimed at enhancing the effectiveness of packaging to meet the different delegate and sponsor companies in the pharmaceutical industry as it evolves.

How Serialization Works in the Pharmaceutical Industry:

In the pharmaceutical sector, serialization works by giving each product a special code or serial number that makes it easier to identify and this process typically includes the following steps:

Regulatory Compliance:

• Regulation demands are a major force for serialization. Drug supply chain security acts (DSCSA) in the US and Falsified Medicines Directives (FMD) in the EU are just two examples of the requirements that pharmaceutical businesses must abide by.
• According to regulatory bodies, compliance entails adhering to particular serialization requirements and deadlines.

Integration with Track &Trace System:

• A more comprehensive track and trace system requires serialization.
• End-to-end visibility and traceability of pharmaceutical items are made possible by these technologies, which aid in the detection and resolution of problems such as product recalls, diversion, and counterfeiting.

Pharmaceutical Packaging: The Significance of Serialization:

Pharmaceutical product serialization gives all parties involved—including regulators, producers, distributors, healthcare professionals, and even patients—control and oversight over their products. In the industry, it's significant for the following reasons:

Better distribution & Supply chain Operations:

• Complex supply and logistics are major issues faced by the pharmaceutical business. Supply chain visibility, improved inventory management, and increased operational efficiency are all made possible by serialization.
• Across their whole supply chain, they have improved governance.

Identify & Prevent counterfeit products:

• The proliferation of fake medications was the main factor in serialization becoming required.
• Medical product authenticity and verification are made possible by serialization, which also ensures customer safety by confirming that the products were supplied lawfully and safely.

Improved Recall of Product:

• Serialization makes it simple to recall a batch of products if there is an issue.
• As the products are being tracked for accurate accounting, unique serial numbers can assist stakeholders in locating the products and working to get them back.

Data Access:

• Data Access Manufacturers can access large amounts of market and product-specific data through serialization.
• You can use data-driven predictions to make better-informed decisions about your production, logistics, and sales channels, as well as insights into your customer's purchasing behavior and surroundings.

Pros & Cons of In-line serialization:

• It can automatically handle every level of serialization, so there is no space for error.
• It doesn't impede your operations or production processes after it's been put into place.
• It is costly to adopt since manufacturers who do not currently have this kind of automation in their manufacturing lines will need to purchase new production machines.
• To handle and debug any issues that may develop during use, greater expertise is required. Employee retraining and training will probably be necessary.

Label Serialization:

• Due to the lack of automated production lines, label serialization is used by the majority of small to medium pharmaceutical enterprises.
• By using a labelling machine or a hand-held labelling equipment, the products' sticker labels bearing the serial codes are applied either automatically or semi-automatically.

Pros & Cons of Label Serialization:

• It is less expensive to apply.
• Unlike in-line serialization, it can be built in a matter of days.
• Error is possible due to the human factor.
• This approach becomes more difficult to use the more packaging levels that must be serialized. It will also slow down your production and operation process because it's a new procedure that needs labor.