How Technology is Changing Drug Recall
- November 29, 2016
- Posted by: AXSource
- Categories: Blog, Regulatory and Quality
Drug Recall occurs when a prescription or over-the counter drug gets removed from the market. This usually happens when the product is either found defective or potentially harmful.
The creators can voluntary remove it from the market if they discover a problem with their drug. Or a governing body, like the FDA, can also request for the product to be recalled after they’ve received reports of problems from the drug.
But why are these drugs recalled? There are various reasons for drug recall:
- Health Hazard: Most of these health risks are unfortunately not discovered, until they become widely used. People can react very differently because of the medication, and it’s hard to realize the risks until cases appear.
- Mislabeled/Packaged Wrongfully: Sometimes instructions of the dosage amounts can be confusing and misunderstood.
- Contamination: The product could have been contaminated with a harmful substance, either during production or distribution.
- Manufacturing Problems: Defects related to the quality and purity of the drug could be a valid reason for a recall.
However, the real problem is recalling the drug. If the drug was discovered to be contaminated during processing, then manufacturers are required to immediately stop distribution, and a corrective action plan (CAPA) must be launched. Otherwise, if the problem was discovered after distribution, then these manufacturers must recall the affected batches, investigate, and do an effectiveness check then report back to the regulating body.
Are you Prepared to Handle a Product Recall?
When a company finds themselves in this situation, these processes can take quite some time. There’s a constant pressure to act fast and return to normal operations. It’s why the best way to handle a drug recall, is to prepare for it.
There are many types of software available that are suited for handling this type of situation, but only few use it to their advantage. Vendors have created ERPs that is not only compliant, but great at reversing logistical processes—which makes it easier for traceability, tracking and recall management. That way information, like the material lot and serial numbers, can be collected, making it easier to trace the defective batch.
Another crucial part of managing a product recall is inventory management. Companies need to know the status of their products—what stage of production they are in, which vendor they went to, or in which company warehouse they’re stored in. Advanced systems possess these types of features, which cuts down on the time spent on tracking and allows for a smooth and effective recall process.
Communication is very important, it’s what will make recalling products efficient. Lines of communication across all departments should be established and clear. This means information will be easily gathered from each part of the company, which will be used to strategize recall operations. Furthermore, stakeholders such as the regulatory board and vendors, need to be notified and updated throughout the process so they will be prepared for what’s to come.
There is software designed to interpret the data companies own, which helps manufacturers and distributors in tracking the production and supply chain. Some of these ERPs have integrated compliance regulations and recall management, to help with fast and proper execution. It takes a lot to coordinate the entire process, and having the right technology to track the supply chain and manufacturing, streamlines the recall procedure.
Recall Management streamlines product recalls and withdrawals by providing complete traceability of products and raw materials.