Celsis aims to provide its customers with not only the tools to perform adequate and affordable testing, but to do it expeditiously.
“The laboratory is typically viewed as a bottleneck in the production process,” explains Scdoris, who prior to joining Celsis, worked for 15 years in quality control for the dairy industry. “Production is trying to do things ‘just in time’ and respond to their customers as quickly as possible. So, they produce a product, but it gets held up in quality control awaiting testing so it can be released.”
The Celsis RapiScreen product, which uses adenosine triphosphate (ATP) bioluminescence, can screen food and beverage products to assure sterility and release them in 48 hours, compared to what can sometimes take up to 4 days or more—a huge benefit to a company’s financials, Scdoris points out.
In addition, laboratories see a benefit in having technology tools, such as those offered by Celsis, that generate electronic records as opposed to “notebooks full of paper records,” says Scdoris.
“Auditors want to know that a company has the ability to retrieve information from the testing that they’ve conducted. That’s a very big trend these days.”
FDA’s Q&A on Product Tracing and Recordkeeping
Q: What is product tracing and why is it important?
A: In general, a product tracing system involves documenting the production and distribution chain of products so that in the case of an outbreak or evidence of contaminated food, a product can be traced back to a common source or forward through distribution channels.
Product tracing systems enable government agencies and those who produce and sell food to take action more quickly when an outbreak of foodborne illness occurs or contaminated product is identified, thus preventing illnesses. Actions include removing a product from the marketplace and alerting the public if a product has already been distributed.
Many producers, manufacturers and retailers have product tracing systems in place, but they vary depending on the amount of information the system records, how far forward or backwards in the supply chain the system tracks, technologies used to maintain records, and the precision with which a system can pinpoint a product’s movement.
Q: Did Congress provide any specifics about the recordkeeping requirements FDA is to establish for high-risk foods?
A: Yes. Congress has established certain recordkeeping requirements, including the following:
• they must relate only to information that is reasonably available and appropriate;
• they must be science-based;
• they may not prescribe specific technologies to
• the public health benefits must outweigh the cost of complying with the requirements;
• they must be practical for facilities of varying sizes and capabilities;
• to the extent practical, they may not require a facility to change business systems to comply;
• they must allow for the maintenance of records at a reasonably accessible location, provided that the records can be made available to FDA within 24 hours of a request; and