Serialization Challenges of Track & Trace in the Biopharma Industry

10% of drugs sold around the world are fake.  Counterfeit medicines are the cause of on average 1 million deaths yearly.  Increasing of online purchases and disrupted supply chains have intensified and made the risk of counterfeit medicines due to COVID-19.

Drugs are “tracked” once after the product has left the manufacturer and landed where it was intended to be delivered.  Tracing a drug starts before the product leaves the manufacturing facility as well as before it even arrives to the manufacturing site.  All pieces that were involved in producing the product is tracked in a database.

Tracking and tracing was created to help reduce the number of counterfeit medicines.  Although, after 10 years of tracking and tracing products, the pharmaceutical industry still runs into incidents with counterfeit medication.  Even now more than ever, due to the rush for COVID-19 Vaccines, companies are looking to purchase them anywhere.  It is important to make sure these vaccines are tracked, traced and pass inspection.

Today, there are many measurements taken to ensure the quality of a drug product, equipment, materials, etc.  The EEO system is used to limit the need for an operator.  This helps with keeping products as clean as can be, without an operator bringing in extrinsic contaminants.  Sterilization technology has limitations. Systems must have low complexity with its operations, able to exchange data in a safe and error-free manner.

All products are required to prove quality assurance, show that each product has been through an inspection and was approved to be distributed to hospitals and patients.  InQuest Science’s Identifier system is built to help track and trace all data involved in producing a drug product.  This software will be used to ensure product quality, track and trace all information on a drug product and make it easier to figure out if products are defective.  It is built to help improve work-flow and reducing issues pertaining to data integrity.  Having a cloud-based data importing system will help to control the amount of counterfeit medication.

Read the full article published by BioPhorum on Pharmecutical Online

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