For the pharmaceutical industry, FDA legislation is geared to bring both the distributor's and manufacturer's industry quality control standards to high levels of safety. Not only are pharmaceutical distributors and manufacturers required to keep control of their inventory recalls and know what products were shipped to which clients, but if they fail to comply they risk severe penalties and a complete recall of all shipments. For ERP solution providers, helping pharmaceutical companies meet stringent demands is crucial.
With safety standards clearly defined for the pharmaceutical industry, the intense competition among pharmaceutical companies, as well as other factors - including industry consolidation, consumer-driven pressure, and more - ERP solutions must tip the scale toward offering optimal support that takes into account each of these safety-driven factors. According to Dani Kaplan, an ERP solution expert from SMC Data Systems Inc., these are the top five controls necessary for ERP solution providers to be able to successfully manage stringent safety concerns of the new Safety Act with which pharmaceutical companies must currently comply:
- The computer system should be able to track lot control and shelf life date of all products, in both received and outgoing shipments.
- If a recall ever occurs, the distributors and manufacturers should know exactly which customers received products from that lot number.
- When inventory is received or shipped, the system should be able to determine if a product is beyond the desired threshold for shelf life.
- Products being shipped should be checked if they are outside the customer's threshold for shelf life. If it doesn't meet the threshold shelf life, it shouldn't be shipped.
- Shipping the product beyond the customer's threshold shelf life will result in returns, double freight bills and an unhappy customer.
Kaplan emphasizes that having accurate lot number controls for each product will allow for easy tracking of who got which product and will enable the distributors and manufacturers to notify the customer about the recall. The warehouse staff will know where the unshipped recalled products are located and will be able to pull them off the shelf. Recalled product reports should be available for the FDA inspector proving the recalled products were returned and unshipped inventory in the warehouse were pulled off the shelves and will be destroyed.
There’s also ample evidence that bar-coded labeling is a key concern that ERP software can address. By upgrading to ERP software, pharmaceutical companies can better establish warehouse control of all products received in the warehouse which are bar-code labeled. If the received product doesn't have a bar-coded label, the person who receives the inventory prints the bar-coded label off a small barcode printer that is attached to his/her belt and puts the label on the product. The newly received inventory can then be put in a designated location or a random location. By scanning both the bar-coded label on the product and the location, the computer records will be updated.