9 Parts of a GMP Audit: Ensuring FDA Food Safety Standards
"This complex regulatory environment requires an adaptive and holistic approach to oversight." -- U.S. Food and Drug Administration (FDA) Strategy for the Safety of Imported Food
With millions of food products shipped annually, there is too much risk in assuming that a) either your food suppliers are preparing your product in a hygienic manner, or b) that every parcel of contaminated food will be detected before it reaches market shelves.
There are simply too many food products being manufactured and shipped around the world, and too many supply chains involved.
To address these problems, a Good Manufacturing Practices (GMP) audit should be an essential part of your overall Quality Assurance program.
In this article, we'll explain what a GMP audit is, why it's essential, and 9 parts of a GMP audit (plus, the FDA's strategy) that you can expect to see.
What is a GMP Audit?
A GMP audit is a comprehensive, third-party inspection of a production company. It is meant to identify operational flaws and legal violations.
Along with specific inspection results, GMP audits are meant to communicate a set of standards and guidance on how to meet these standards.
Why is a GMP Audit Essential to Every Food Business?
The numbers show why.
According to the U.S. Food and Drug Administration’s Strategy for the Safety of Imported Food:
- The United States imports about 15% of its total food supply, including:
- 32% of vegetables
- 55% of fruits
- 94% of seafood
- The United States imports food from over 200 countries, and from
- approximately 125,000 exporting food facilities and farms
- The FDA expects between 14 and 15 million shipments of imported food in 2019
- The U.S. Center for Disease Control estimates that each year in the United States:
- 48 million people get sick from foodborne illnesses
- 128,000 are hospitalized
- 3,000 people die as a result
The FDA's Strategy for the Safety of Imported Food
Released in February of 2019, the FDA's Strategy outlines a new approach to food safety measures. It was designed to meet the growing complexity of global markets and supply chains.
Based on the Food Safety Modernization Act (FSMA) of 2011, the Strategy calls for a stronger focus on education and prevention, as opposed to just violation detection measures.
Feeling the need to adapt to the growing complexity of global supply chains, the FDA reevaluated its monitoring resources and capabilities, and set more efficient goals for importers to follow.
Thus the focal shift to contamination prevention at the supply source.
In lieu of the available resources to inspect every food product that comes to market, supply chain audits and educational efforts are a more sustainable way of ensuring safe food handling practices.
The Strategy's Primary Goal
Goal Number One, as stated in the Strategy, is that "Food Offered for Import Meets U.S. Food Safety Requirements." In order to meet this goal, the FDA wants U.S. food safety standards to be the standard followed by every link in the food supply chain -- both foreign and domestic. It stresses:
- Holding all suppliers to uniform supplier verification requirements;
- Cooperating with domestic and foreign regulatory counterparts to determine agreeable and uniform safety standards;
- Giving legitimacy to reliable third-party audits and other assurance programs aligned with U.S. food safety requirements; and
- Providing information sharing and training programs to help supply chain companies establish stronger GMP.
The FSMA gives the FDA a powerful tool known as the Foreign Supplier Verification Program (FSVP), requiring all U.S.-based food importers a) to conduct a hazard analysis of the food and its foreign suppliers, and b) conduct verification activities based on the analysis. According to the FDA, as it continues to build its inventory of FSVP importers, it will "increase its understanding of their connections through the supply chain."
How Does Reliable Third-Party Auditing Improve the FDA's Effectiveness?
The FDA acknowledges the value behind independent auditing programs and their benefit to public health when they are aligned with relevant FDA food safety requirements.
A comprehensive GMP audit is seen as more than just an on-site inspection. They provide an opportunity to collect valuable practices data, communicate directly with supply chain operators and employees, establish workable solutions to daily hygiene challenges, and develop educational programs to all motivated suppliers in need of better training.
In addition, importers involved in an accredited auditing program are eligible for the FDA's expedited importation program called the Voluntary Qualified Importer Program (VQIP).
What (9 Parts) Does a GMP Audit Include?
The FDA's GMP Audit checklist consists of nine parts, covering:
1. Personnel. The checklist covers a supplier's procedures for reporting employee illnesses, employee dress codes, food handling procedures, training methods, and supervision policies.
2. Plant and Grounds. Auditors assess building functionality, surrounding lot cleanliness (overgrown weed maintenance, litter, standing water, etc.), storage units, glass and light bulb protection, and proper ventilation.
3. Sanitary Operations. The frequency and thoroughness of facility and equipment cleaning, toxic substance storage practices, single-use paper disposal procedures, and pest control effectiveness.
4. Sanitary Facilities and Controls. Consistent use of potable water; water temperature and pressure appropriate for manufacturing use; adequate plumbing and floor drainage systems.
5. Equipment and Utensils. Proper cleaning and maintenance of, as to prevent adulterants into food material; equipment made from non-toxic, corrosion-resistant material; surfaces and contours designed to prevent the accumulation of microorganism growth; adequate refrigerator and freezer equipment with accurate temperature monitoring.
6. Processes and Controls. Quality control checks on all raw materials and : work areas for microorganisms; cross-contamination and allergen potential; food packaging and shipping procedure checks.
7. Warehousing and Distribution. Proper hauling and storage procedures, records of previously shipped loads by individual containers, stock rotation, proper safety labeling.
8. Holding and Distribution of Human Food By-Products for use as Animal Food. Assurance that designated containers meant for human by-products are properly designed and labeled so as to clearly distinguish its use as animal food and not to be confused with trash.
9. Defect Action Levels. Procedures put in place to immediately address product defaults.
What is at Risk Without a GMP Food Audit?
As stated, it is not in the FDA's capacity to inspect every food item manufactured and sold in the U.S. The responsibility for ensuring safe food manufacturing practices must necessarily fall on the business with its name prominently on the label.
Attempting to stop food processing violations and contaminations after the product has come off the line will catch up to your business. Odds are that contaminated food will eventually make its way to consumers and make them very ill. Above all other considerations, when supply chains are not held to the highest safety standards, the public's health is at risk.
When you can partner with an accredited third-party supply auditing service, you have the opportunity to change the culture of your supply chain and mitigate the risk.
How Can a QIMA GMP Audit Help?
Along with providing inspection thoroughness and fostering open dialogue between our auditors and your supply chains, we believe that one of our prevailing strengths is in our prompt report delivery.
By prioritizing report drafting as a time-sensitive obligation, quality and abundance of pertinent details can be better captured and, in turn, the quality of corrective recommendations can be maximized.
Our auditors bring the highest level of technical expertise because they are specifically trained by audit type and scheme, requiring mandatory in-depth training and strict internal audits.
Information transparency and auditing refinement are goals shared by QIMA and the FDA. Above all, we share a commitment to food safety and public health. Let our GMP food audits ensure that best food-handling practices are being used at the source.
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