Why is Lot Tracking For Pharmaceutical Manufacturers So Important?
Around seven percent of all medicines worldwide are counterfeit, which is a frightening number considering how many people depend on medications to live normal lives. Counterfeit medicines are illegal and extremely dangerous for patients. Due to the growth of counterfeit medications flooding the market, Lot Tracking for Pharmaceutical Manufacturers has been growing as well.
Restrictions and Regulations
The United States FDA Safety and Innovation Act (FDASIA), signed into law July, 2012, allows the FDA the authority to gather user fees from the industry to finance reviews of medical devices, innovator drugs, biosimilar biologics, and generic drugs. These include, but are not limited to:
ARCOS Reporting –
ARCOS Reporting is an automated drug reporting system that keeps an eye on controlled substances as they pass from the manufacturer all the way to the point of sale, including pharmacies, hospitals, teaching institutions, and practitioners.
Pedigree and ePedigree –
A process that provides serialization for all units of sale, regardless of size. Any drug distributed by wholesalers, repackagers, or distributers must have a pedigree. ePedigrees are nothing more than electronic records of pedigrees.
National Drug Code (NDC)
– These are numbers identifying human drugs listed in the FDA’s Drug Registration and Listing System (DRLS).
What is Lot Tracking?
Lot tracking is an effective method through which pharmaceutical manufacturers can track and trace their medication. This allows healthcare companies to remove both counterfeit medications and recalled medications. Lot tracking is essential for inventory management and supply chain integrity.
Lot tracking records data on a specific quantity of product – gallons, pounds, etc. – and makes it easy for manufacturers to trace the raw materials within a specific batch of medications.
Lot tracking simplifies the process in determining:
- which batches of medications are ready for purchase
- which batches expired and, if necessary,
- which batches of medication need to be recalled.
- (In the event of a recall, lot tracking allows the manufacturer to easily identify and target the specific problematic batch.)
To make this possible, each batch created is assigned a lot code, which is a unique series of numbers specific to that batch. In the event of a recall, manufacturers can use lot codes to see when the problem happened and what products were affected. The lot codes can also be used to answer patient, government, or processing questions and create the Pedigrees and ePedigrees required by law. These Pedigrees are identifying statements provided by certain wholesale distributors “prior to each wholesale distribution of prescription drugs.”
Supply Chain Integrity
These drug Pedigrees are not only required by law, but are also vital to creating supply chain transparency. A manufacturer’s reputation is directly linked to the integrity of its supply chain. Lot tracking increases supply chain integrity by tracing the Pedigree of each batch of drugs manufactured. Pharmaceutical manufacturers are held strictly accountable through these new rules and regulations regarding the manufacturing and distribution of prescription drugs. Through lot tracking, the ingredients and dosage of each batch of medication will be traced throughout all stages of production, processing and distribution.
Mitigating Risks and Liability in the Pharmaceutical Industry
-Enhanced Traceability: Lot Tracking for Pharmaceutical Manufacturers ensures each batch of pharmaceuticals can be traced through the supply chain, reducing the risk of distributing compromised products.
– Efficient Recalls: Quick identification and removal of defective or contaminated batches minimizes harm to patients and reduces legal exposure.
-Regulatory Compliance: Adhering to stringent tracking requirements helps avoid fines and legal actions from regulatory bodies.
-Quality Assurance: Continuous monitoring of lot performance helps in maintaining high product standards and identifying potential issues early.
-Consumer Trust: Transparent tracking processes build confidence among consumers and stakeholders in the reliability and safety of pharmaceutical products.
-Risk Management: Proactively identifying and mitigating risks associated with production and distribution reduces overall liability.
Implementing Lot Tracking Systems
Implementation of Lot Tracking for Pharmaceutical Manufacturers requires a series of dedicated steps which must be customized as per the business size and nature.
- Clearly outline the goals and objectives of implementing the tracking system.
- Ensure regulatory compliance and consider scalability, integration capabilities, and ease of use.
- Choose a system that aligns with your operations’s specific needs.
- Develop standardized procedures and protocols for lot tracking.
- Implement a process for ongoing monitoring, auditing, and review of the lot tracking system.
- Optimize the lot tracking system based on feedback, performance metrics, and emerging technologies to enhance efficiency and effectiveness.
Save money, Avoid Poor PR, and Maintain Reputation
Lot tracking aids manufacturers in the following of government rules and regulations regarding the manufacturing of pharmaceuticals. However, the bottom line is that lot tracking will help manufacturers save time and money, avoid poor public relations issues, and maintain a solid reputation. Most importantly, lot tracking will put counterfeiters out of business and keep patients healthy and safe from the dangers of counterfeit and recalled medications.
