Essential Ingredient in Food Safety: Making the Most of GMP

Informed by the Food Safety Modernization Act (FSMA), manufacturers are required to implement processes that actively reduce the risk of foodborne illness, both from known pathogens and unknown agents. These processes are critical to track the type and nature of these illnesses and mitigate their impact — according to the CDC, 48 million Americans fall ill with food-related sickness each year. Of those, more than 100,000 are hospitalized and on average 3,000 will die.

To help standardize the creation and implementation of food safety processes, U.S. Food and Drug Administration (FDA) has created a best practice guideline: GMP. For Quality Managers, Plant Managers, and Process Improvement Leads in the food industry, GMP compliance is the backbone of a reliable quality management system. Here’s a look at what it is, where GMP applies, and how your business can make the best use of this essential safety ingredient.

What are Good Manufacturing Practices (GMP)?

According to the FDA, “GMPs describe the methods, equipment, facilities, and controls for producing processed food.” Good manufacturing processes were developed as a way to standardize frameworks around facilities management, food processing, and packaging operations to help reduce the risk of foodborne illness in the supply chain and provide clear directives to food processors and manufacturers.

GMP forms the foundation of broader quality management frameworks such as ISO 22000, FSSC 22000, and HACCP plans. For organizations pursuing or maintaining these certifications, GMP compliance is a prerequisite that Quality Engineers and Lead Auditors must continuously verify through structured audit programs.

Key components include adequate maintenance of facilities and buildings, the design and maintenance of equipment, record keeping, the development of reliable sanitization processes and controls, and the establishment of defect action levels (DLAs) that may prompt responses from the FDA.

Worth noting? Some GMPs are general, while others are more specific. For example, plumbing must be of “adequate size and design” to support facility operations, but companies are obligated to install self-closing doors for all toilet facilities.

Benefits of GMP Certification for Food Businesses

GMP certification is a voluntary process that demonstrates your compliance with the Good Manufacturing Practices for food safety. For quality-focused organizations tracking KPIs like non-conformance rates and cost of poor quality (COPQ), GMP certification delivers measurable improvements. By obtaining certification, you can:

• Enhance your reputation and credibility among customers, suppliers, and regulators
• Reduce the risk of foodborne illnesses, recalls, and legal actions
• Improve your operational efficiency and productivity while driving down COPQ
• Gain a competitive edge in the market and satisfy customer audit requirements
• Access new markets and opportunities, including those requiring ISO 22000 or FSSC 22000 alignment

How to Achieve GMP Certification

To get GMP certified, you need to undergo an audit by a third-party organization that verifies your adherence to the GMP standards. Quality Directors and VP Quality Assurance leaders should ensure their teams are audit-ready at all times, not just when a certification cycle approaches. The audit will cover aspects such as:

• Facility design and maintenance
• Equipment design and maintenance
• Personnel hygiene and training
• Sanitation and pest control
• Production and process controls
• Record keeping and traceability

Common GMP Violations and How to Avoid Them

GMP violations are the instances where you fail to comply with the GMP requirements for food safety. For Quality Supervisors and QA Managers, tracking non-conformance trends is essential to preventing repeat violations and reducing audit fatigue across your sites. Some of the common violations are:

• Lack of proper documentation and records — a leading cause of audit findings under FDA cGMP and ISO 22000
• Inadequate cleaning and sanitizing of equipment and utensils
• Poor personal hygiene and health practices of employees
• Improper storage and handling of raw materials and finished products
• Failure to monitor and control critical parameters such as temperature, pH, moisture, etc.
• Use of expired or contaminated ingredients or additives

To avoid GMP violations and improve your quality KPIs — including audit completion rates and time to resolution — you should:

• Implement a written GMP program that outlines your policies and procedures for food safety
• Train your staff on the requirements and their roles and responsibilities
• Conduct regular inspections and audits to check your compliance status and identify any gaps or issues
• Correct any non-conformities or deviations as soon as possible and document the corrective actions taken using a digital CAPA workflow
• Review and update your GMP program periodically to reflect any changes in regulations, processes, or products

What is a GMP Audit?

A GMP audit is an end-to-end evaluation of GMP processes by a third party to ensure compliance for food processors. The goal of these audits is to identify any potential areas of concern and help companies remedy regulatory deviations to boost overall food safety and ensure compliance. For organizations managing multiple production sites, digital audit tools provide the cross-site comparability that Quality Directors need to benchmark performance and allocate resources effectively.

It’s worth regularly conducting audits to assess compliance since the cost of bringing in a reliable auditing firm is typically far less than the potential downtime that comes with a failed FDA audit. Tracking audit completion rates and non-conformance closure times gives QA Managers the visibility needed to demonstrate continuous improvement to regulators and senior leadership.

Best bet? Start with a GMP checklist to see where your processes meet expectations and where they could use improvement.

How to Prepare for a GMP Audit and What to Expect

A GMP audit is an assessment of your compliance with the GMP standards for food safety by an external auditor. Whether you are preparing for an FDA cGMP inspection, an ISO 22000 surveillance audit, or a HACCP verification review, structured preparation is critical. A GMP audit can be conducted by:

• A regulatory authority such as the FDA or CFIA
• A certification body that offers GMP certification services
• A customer or supplier that requires compliance as part of their contract

To prepare for a GMP audit, you should:

• Review your GMP program and ensure it is up-to-date and complete
• Gather all the relevant documents and records that support your compliance claims
• Conduct a self-audit or a mock audit to identify any potential weaknesses or areas of improvement
• Address any findings or recommendations from previous audits or inspections and verify corrective actions have been closed out
• Communicate with the auditor in advance and confirm the scope, schedule, and expectations of the audit

How to Implement GMP Training for Your Staff

GMP training is an essential component of your GMP program that ensures your staff has the knowledge and skills to perform their duties in accordance with the GMP standards for food safety. Effective training programs are a core requirement under FDA cGMP, HACCP, and ISO 22000 — and they directly impact quality KPIs like first pass yield (FPY) and non-conformance rates. To implement GMP training for your staff, you should:

• Conduct a training needs analysis to determine who needs to be trained, what they need to be trained on, how they need to be trained, when they need to be trained, and how their training will be evaluated
• Develop a training plan that outlines the objectives, content, methods, resources, schedule, and assessment of your training program
• Deliver the training using various techniques such as lectures, demonstrations, videos, quizzes, games, etc.
• Evaluate the effectiveness of your training using various methods such as tests, surveys, observations, feedback, etc.
• Record and document your training activities and results in your quality management system for audit traceability
• Review and update your training program periodically to reflect any changes in regulations, processes, or products

Food Safety First

GMP and cGMP are key components of an effective food safety program and a robust quality management system. By regularly reviewing these requirements for updates, and assessing current compliance with in-depth checklists and structured quality audit processes, food manufacturers and food businesses can streamline operations, ensure food standards are met, and remain confident in food safety frameworks. When paired with complementary standards such as HACCP, ISO 22000, and FSSC 22000, GMP provides the process control foundation that Quality Managers and Plant Managers need to drive continuous improvement and reduce cost of poor quality.

Ready to boost GMP best practices? Take on food safety with Certainty.

Frequently Asked Questions (FAQs)

What is the difference between GMP and cGMP?

GMP (Good Manufacturing Practices) and cGMP (current Good Manufacturing Practices) both refer to FDA regulations governing food and pharmaceutical manufacturing. The “c” in cGMP emphasizes that manufacturers must use up-to-date systems and technologies — not just follow the original guidelines. For Quality Engineers and Lead Auditors, this means audit programs must verify that facilities are using current best practices, not simply meeting baseline requirements established years ago.

How does GMP relate to HACCP and ISO 22000?

GMP serves as a prerequisite program for HACCP (Hazard Analysis and Critical Control Points) and ISO 22000 food safety management systems. While GMP establishes the foundational hygiene and operational controls, HACCP focuses on identifying and controlling specific hazards at critical control points. ISO 22000 integrates both GMP and HACCP into a comprehensive management system framework. Quality Managers overseeing food safety programs typically need all three working together to achieve full regulatory compliance and certification readiness.

How often should GMP audits be conducted?

Most food manufacturing organizations conduct internal GMP audits on a monthly or quarterly basis, with formal third-party certification audits occurring annually. The frequency depends on your risk profile, regulatory requirements, and quality KPIs such as non-conformance rates and audit completion targets. QA Managers at multi-site operations often stagger audit schedules to maintain continuous oversight without creating audit fatigue across their teams.

What quality KPIs should be tracked alongside GMP compliance?

Key performance indicators for GMP-aligned quality programs include audit completion rates, non-conformance rates, corrective action closure time (time to resolution), first pass yield (FPY), and cost of poor quality (COPQ). Tracking these metrics gives Quality Directors and VP Quality Assurance leaders the data they need to demonstrate compliance effectiveness, justify resource investments, and benchmark performance across production sites.

Can digital tools replace paper-based GMP audits?

Yes. Digital audit and inspection platforms eliminate the inefficiencies of paper-based GMP audits by enabling real-time data capture, automated corrective action workflows, and centralized reporting across multiple facilities. For Quality Supervisors managing day-to-day compliance and Plant Managers overseeing operations, digital tools provide instant visibility into audit status, non-conformance trends, and CAPA progress — replacing manual processes that are prone to errors, delays, and inconsistent cross-site comparability.

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