FDA new regulation: Improving pharma product security through serialization and track & trace

The FDA in the United States is the regulator for Pharmaceutical drugs and plays various roles in the human health field. Among them, the most critical is the safety of pharma products. It establishes and maintains various regulations so that pharmaceutical products are safe for human consumption.

Serialization and Track & trace are many techniques that ensure drug safety after it goes out of the manufacturing plant.

Introduction

Serialization is the process of assigning a unique serial number to each pharmaceutical finished pack that goes out of the packaging process. These packs are then distributed among various users such as Patients, Doctors, and hospital staff. Each serial number represents critical information about the pharma pack, such as Product constituents, shelf life, batch number, and other manufacturing information. The unique serial number can be tracked throughout the entire supply chain life cycle. The serial number is unique for every product and cannot be copied and pasted to another product.

Track and Trace is a technique used in the Pharmaceutical supply chain life cycle to trace pharma products until they reach their intended use and are fully consumed. It enables the manufacturer to locate the product’s current and previous location. Track and Trace can be used to pinpoint any source of bad practices or any alteration being done with the product. The main purpose of track and trace is to detect any problem with the product after it is released into the market from the manufacturer.

Importance

The FDA has signed a Drug Supply Chain Security Act (DSCSA) law. According to this law, the FDA plans to implement an interoperable system to trace every pharma product that has been launched in the United States Market. Under this act, every product should be identifiable and traceable at every supply chain level.

The main objective of this law is to include all the supply chain stakeholders in the development of such a system so that the system should be easily accessible and can be implemented realistically. It should reflect the actual ground realities of the pharma supply chain. For this purpose, the FDA has launched a pilot project called DSCSA Pilot Project Program. This is initiated to identify potential problems and find the best possible solutions to solve those advantages.

Some important points of the Drug Supply Chain Security Act (DSCSA) are mentioned below

· Identifying different system requirements used in implementing DSCSA law.

· Assessing the abilities of supply chain partners in implementing the DSCSA law

· Assigning resources to identify, manage, and prevent the distribution of suspect and illegitimate products 

· To exchange information throughout the supply chain in an electronic and interoperable manner

Process of Product Identifier

· The manufacturer is responsible for installing the system that enables the product to be tracked and traced. The design should be capable enough to deploy marking to each product without error. The process of the product identified should have the following properties.

· Generation of Unique identification marks: They are generated at the manufacturer site before marking the pharma product with a unique identifier. The manufacturer is responsible for arranging desired equipment, resources, and manpower to operate the equipment. The manufacturer is also responsible for the correct functioning and rectifying any problems.

· Each unique product identifier is assigned to a specific product, batch, and lot number. Once assigned, the particular identifier cannot be used again for another product, batch, or product.

· The manufacturer should define the format of the product identifier and should follow this format and pattern throughout all the organizational functions.

· The format of the unique product identifier must be according to the FDA-approved format and must not deviate from it. 

· The equipment used to print or affix the product identifier should be reliable and prevent any missing or erratic working. Additionally, the manufacturer should implement best practices to avoid any problems with the printing equipment.

· As mentioned in regulatory guidelines, the product identifier should be applied to every product.

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Serialization and Track & Trace

Serialization and Track & Trace are implemented together. A product cannot be effectively tracked and traced without proper serialization resources. The serialization is the building block of the track and trace system and allows the manufacturer to assign unique identifiers to the product.

Methods of track and trace

There are various methods of pharma product track and trace that is successfully used to trace each activity throughout different steps of supply chain.  

Barcode

The barcode is a standard method of representing data in a visualized form. Additionally, this format is machine-readable and can be readable by specialized readers. These readers, often called Barcode Scanners, can detect different barcode patterns and read the underlying data.

The FDA 21CFR201.25 describes the rules and regulations when implementing the Bar Code. According to this rule, the following elements of the supply chain are required to implement

· Manufacturers

· Repackers,

· Relabelers,

· private label distributors of a human prescription drug product

Information required in a Barcode pattern

The 21CFR201.25 also provides guidelines about the type of information required in the barcode, which becomes necessary for all the stakeholders to include in their product line. Under this regulation, the following information is required

· Appropriate National Drug Code Number

· The barcode should remain attached or be printed under all working conditions because the pharma products go through different environments, transport, and storage conditions throughout the supply chain life cycle. They are also subject to varying temperatures, such as hot and cold temperature regions. This condition can affect the barcode appearance, and information contained in the barcode can be lost or can be unable to be scanned by the barcode reader. 

· There must be sufficient space around the barcode to be scanned appropriately and correctly. Practically, the barcode will not scan if enough space is not left around it. 

· The barcode should be printed on the pack to be easily seen, and the scanner can also quickly scan the barcode.

Type of Product that require a Barcode

As per 21CFR201.25, following products are subject to the barcode

· Prescription drug products, excluding samples, allergic extracts, medical gases, and Radiopharmaceuticals

· Biological Products

· Over the Counter (OTC) drugs intended directly for hospitals i.e. packed, label, marketed, promoted or sold to hospitals

Types of Barcode

There are two types of Barcode Code commonly used in the pharmaceutical industry – Linear and Two Dimensional.

Linear barcode

Linear barcode is the commonly used barcode that contains National Drug Code (NDC) number. This type is also used for US Point of Sale (POS) requirements.

Linear Barcode can contain up to 12 digits. Its drawback is that it cannot have critical drug data such as Expiry date and other batch identification data. It is only used to relate the NDC number to the drug mentioned above.

Two-dimensional (2D) data matrix barcode

A two-dimensional (2D) barcode is a combination of many small dots in rectangular or square form. The 2D barcode can contain a significant amount of information, which can be successfully extracted. For 2D barcode, size does not matter, provided the entire pattern is not disturbed or changed.

The 2D barcode has become a regulatory requirement for every pharma product in the United States market. The Drug Supply Chain Security Act (DSCSA), imposed in 2017, is the relevant act. According to this act, every pharma product intended for the users in the United States market should contain a 2D barcode, which must contain the following information about the product.

· National Drug Code (NDC)

· Serial Number

· Lot Number

· Expiration Date.

Challenges

Like every new initiative or project, there are some challenges. These challenges sometimes become hard to control, but as time advances, they create new opportunities for the stakeholders and open new dimensions. Some challenges related to Serialization and Track & Trace can include the following.

Equipment

The serialization and product identification process is different from other product or label printing common in the pharmaceutical industry. So it is often faced with some challenges for the manufacturers. Some of which are mentioned below

· It requires specialized equipment that initially generates unique identifiers. These unique identifiers must be according to the approved format, with the relevant information. 

· The printer used for printing these product identifiers should also be capable enough to print these identifiers in a readable format without changing or damaging the appearance. 

· In most cases, these printers are attached to the machines to print the finished packs as it comes out of the packaging process. So for this reason, the printer's speed should match the speed of the machine, as today's packaging machines are high speed. If the printer does not match the speed, the chances are that some packs will be miss-printed.

Data Base

The database of these product identifiers is used for tracking purposes, so the database must be interoperable. The database should also have a universal software solution, architecture, and easy data access across all the stakeholders.

Barcode Integrity

Protecting and securing the information represented by the barcode is also critical. External factors such as environmental conditions, transportation, storage, and handling should not affect the physical appearance of the barcode. Disturbing the external appearance of the barcode can destroy the information contained in the barcode.

About the Author:

Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.