What is serialization in pharmaceutical?
What is serialization in pharmaceutical?
What is Pharma Serialization? Pharma Serialization is assigning a unique code to the packaging of each drug and printing this code on the packaging by any method. There are two main points in this definition. The first is the unique code and the second is the drug packaging.
What does serialization mean in healthcare?
Serialization is the assignment of a unique serial number to each salable prescription product unit. Each prescription product contains information about the product’s origin, batch number and validity date. In the pharmaceutical industry, counterfeit and substandard drugs threaten public health all over the world.
Why is pharma serialization required?
Serialization requirements make it easier for participants in the pharmaceutical industry to determine the authenticity of drug products, identify and remove illegitimate or expired products from the supply chain, and accelerate the processing of drug product recalls.
What is serialization FDA?
Serialization assigns a unique serial number linked to information about the product origin, batch number, and expiration date, to each saleable unit of each prescription drug product.
What is serialization compliance?
serialization helps protect consumer safety through proper labeling management of packaging processes. This can help protect brand reputation by increasing patient safety. Visibility in the Supply Chain.
What is product serialisation?
Product serialization is the process of assigning a unique identity to each saleable product item. This identity can be assigned by affixing a unique code on each product item, usually in the form of QR code or NFC or RFID, etc.
Do medical devices need to be serialized?
Manufacturers are required to track certain devices from their manufacture through the distribution chain when they receive an order from the Food and Drug Administration (FDA) to implement a tracking system for a certain type of device.
What is serialization in microbiology?
Serialization is the assigning of a predetermined coding type to each product item, assigning it with a distinct identity to be tracked and traced to its location in the supply chain or where it had been in during its life cycle.
What are serialization requirements?
Serialization requires a comprehensive system to track and trace the passage of prescription drugs through the entire supply chain. Serialization could potentially identify every product by a unique serial number in addition to the origin, shelf life and batch number for that product.
What products are exempt from DSCSA?
An intravenous solution intended for the replenishment of fluids and electrolytes.
