New FSMA Guidelines for cGMP’s
Leave a CommentAccording to the Centers for Disease Control and Prevention (CDC), about 48 million people in the U.S. (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases. This is a significant public health burden that is largely preventable.
In 2015, the FDA Food Safety Modernization Act (FSMA) was enacted to help prevent foodborne illness rather than simply responding to it. FDA has seven major rules in regards to FSMA for both human and animal food. The FSMA rules are designed to make clear specific actions to prevent contamination.
CGMPs for animal food
CGMPs for animal food production cover elements like personnel, sanitation, work environment, water quality, equipment and more. Jenny Murphy, a consumer safety officer at FDA’s Center for Veterinary Medicine, explained that CGMPs are typically actions manufacturers should already be making throughout the normal course of their business.
“I would say the CGMPs establish a base to make sure you don’t contaminate the animal food and the preventive controls take it a step further by making you really concentrate on things that, if they’re found in animal food, could be a public health concern,” Murphy said, according to the Food & Drug Administration.
For example, according to CGMPs, equipment used for food manufacture should be:
- Adequately cleanable.
- Made from nontoxic materials.
- Properly maintained.
- Protected against contamination.
Preventative controls for animal food
While CGMPs cover the basics of maintaining a sanitary work environment and can be applied to any facility, preventative controls are more individualized to unique plants and are designed to address more specific situations.
“Preventative controls are more individualized to unique plants.”
“Once you have CGMPs in place, you can see where you need extra layers of protection,” Murphy explained. “Preventive controls require a food safety plan that includes an analysis of potential biological, chemical or physical hazards and the steps needed to reduce or minimize that risk.”
Joann Givens, the director of FDA’s Food and Feed Program in the Office of Regulatory Affairs and a co-chair of the FSMA Operations Team Steering Committee, explained that it’s OK – even advisable – to have some redundant processes in place. This way, when one procedure falls short, another can pick up the slack. It ensures all your bases are covered.
Givens explained that preventative controls are important because, if a violation does occur, some of the first questions a facility manager might be asked include:
- Could you have predicted this issue?
- What did you do to prevent it?
- Once it became a problem, what did you do?
- Did you educate your employees about the issue or how to address it?
Every animal food manufacturing plant will have different risks, and therefore each may have different preventative control requirements. Facilities should have preventative controls in place for:
- Processes, like heating or refrigerating.
- Sanitation, like the minimization of pathogens or biological hazards.
- Supply chain.
- Recalls, when they’re needed.
- Any other aspects of the facility where a preventative control might make sense, such as hygiene training or reviews of CGMPs.
Making sure your equipment is compliant
Your process equipment is a large investment, which means you’ll want to make sure it’s compliant from the get-go.
Stainless steel shell and tube heat exchangers are a common component to animal food manufacturing facilities because they meet many CGMP expectations. For example, stainless steel is a highly sanitary surface, which meets the requirement that materials that come in contact with the product should be nontoxic.
Certain configurations also allow for easy cleaning. Tube bundles on u-tube exchangers are often easier to remove, giving easy access to the crevices of the exchanger when cleaning. On the other hand, straight-tube designs don’t have difficult curves to work around when cleaning.
It’s also important to think about the wear and tear equipment sustains over time. Shell and tube heat exchanger processes that involve high-pressure differentials can create more stress on the tubes and tubesheet, making a leak or other form of damage more likely. When a tube springs a leak, the batch of product inside the equipment could become contaminated. This is especially true if the feedwater used is of lower quality than required for animal food production. The U.S. Food & Drug Administration pointed out that this is often the case, which means facility managers must always be aware of the state of their equipment.
The first step in preventing leaks in exchangers – and thus fulfilling CGMPs relating to avoiding contamination – is to regularly inspect the equipment and identify when a problem emerges. Seeing the signs of wear and potential leakage should be enough to pursue repair or replacement of the weathered part or the piece of machinery as a whole.
Understanding the many requirements included in the FSMA isn’t always easy, but it’s important that animal food manufacturers determine where their current weaknesses are and address them sooner rather than later. Murphy explained that the FDA won’t begin conducting inspections to make sure everything is up to code until 2018, but that doesn’t mean there’s time to waste.
For animal food companies looking to upgrade their equipment in compliance with current CGMPs, the engineers at Enerquip can help.