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 ...
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