Track & Trace

2. Employ rapid microbial testing methods. Of the 125 contamination incidents reported through the RFR during its first testing period, which ended last year, 15% were microbial in nature.

This statistic can be reduced through the adoption of fast, reliable testing methods. While traditional microbial testing methods can add four to 14 days to your production cycle, a Celsis Rapid Detection system provides reliable microbiological quality results in just two to five days. By removing days from your product screening process, you will be able to hold each lot until you have confirmation that it is free of microbiological contamination, preventing the need for a recall.

3. Ensure that your solution includes robust record-keeping technology. Complying with the RFR—and having the appropriate microbial testing in place to ensure your products are safe when they leave your facility—isn’t enough. As mentioned earlier, you may be required to provide records to the FDA even if you have previously tested your products and confirmed that they were clean when they left your plant. In addition to the RFR, the FDA enforces specific regulations in its guidelines on the Establishment and Maintenance of Records (EMR), which includes the source of your ingredients as well as what happens to your products once they leave your facility.

The FDA’s regulations on the EMR require a detailed list of information, including, but not limited to, the name and contact information for the source of each ingredient, dates ingredients were received, quantity and type of packaging of these ingredients, details about the transportation companies that delivered ingredients to you and transported products to your recipients, dates your products are released, and more. These records must be created for all lots you manufacture, held for as long as two years, and kept well organized so that you are able to provide them to the FDA in the event of a contamination at any point in the production cycle.

These regulations can be overwhelming for food and beverage manufacturers, but help is available. Although one of the primary benefits of RMMs may be increasing the speed at which you can release your products safely, they can also provide valuable assistance in complying with FDA record-keeping requirements.

For example, advanced RMMs like the Celsis Rapid Detection system include a fully customizable database that allows for storage of records related to quality micro testing and provides query and reporting capabilities that can make accessing specific data quick and easy. The databases allow results to be exported as Excel files to facilitate simple data sharing, and can even be configured for remote access. Results are secure and protected; the database can be installed on a networked server, allowing for scheduled backup. Additionally, the software that supports the Celsis CellScan Innovate system used for dairy, food, and beverage products, called Innovate.im, supports you in your efforts to comply with 21CFR through features like password security, protected data, easy search capabilities, report exporting, record logging, and more.