What Does GMP Certified Mean and Benefits of Certification!

The term “GMP Certified” today is a badge of quality, safety, and trust for manufacturers. But what exactly does it mean to be GMP certified, and why should businesses care?

This guide dives into what GMP certification entails, how you can obtain it, and why it’s a game-changer for companies striving to gain a competitive edge.

You Might Also Like: GMP Checklist for Food Industry!

What is GMP Certification?

Good Manufacturing Practices (GMP) are a collection of rules and regulations designed to keep product quality under control and consistent. In the pharmaceutical, food and beverage, cosmetic, and dietary supplement sectors, regulatory agencies created the Good Manufacturing Practices (GMP) certification, which mostly applies to consumable products or products used to make consumables.

The Food and Drug Administration (FDA) in the United States created GMP requirements under 21 CFR Part 117 for beverages and Part 110 of the Code of Federal Regulations (CFR) for foods. The broad GMP concepts, such as facility and building design, equipment upkeep and cleaning, sanitation, and personnel hygiene, are described in these rules.

Organizations that wish to demonstrate their dedication to putting out high-quality products and keeping customers’ confidence today seriously need to consider pursuing GMP accreditation.

How to Obtain GMP Certification?

Here is a step-by-step guide to obtain GMP certification for companies:

Step 1- Evaluate Current Manufacturing Processes:

Assess all aspects of the manufacturing process, including raw material acquisition, processing, packaging, and storage.
Benchmark current practices against GMP standards.
Record existing protocols and processes, including staff training programs and Standard Operating Procedures (SOPs).

Step 2- Identify Gaps and Make Necessary Adjustments:

Modify production processes to meet GMP requirements.
Implement changes in facility layout, such as creating distinct spaces for raw materials and finished products.
Ensure proper ventilation, lighting, and sanitation standards in all production and packing areas.
Clean and maintain all machinery in compliance with GMP standards.

Step 3- Apply for GMP Certification:

Submit an application to a recognized GMP-certifying organization, such as NSF International, SQF, or BRC.
Prepare for an on-site inspection by the certifying body.

Step 4- On-Site Inspection and Audit:

The certifying organization conducts an on-site inspection to verify compliance with GMP standards.
Auditors will assess manufacturing practices, SOPs, employee training programs, and record-keeping systems.
Any deviations from GMP rules are noted and must be corrected.

Step 5- Address Non-Compliance Issues:

The certifying body will issue a report highlighting areas of non-compliance.
Companies must address these issues and provide evidence of corrective actions within a specified timeframe.

Step 6- Receive GMP Certification:

If the certifying organization confirms that all GMP rules are met, the company receives a GMP certificate.
The certification is typically valid for 1 or 2 years.

Step 7- Ongoing Compliance and Re-Certification:

GMP certification is not a one-time achievement; regular re-certification inspections are required.
Companies must continually review and improve their production processes to maintain compliance with GMP standards.

15 Key Principles of GMP Certification:

Below is a synopsis of the key principles of GMP compliance:

Personnel hygiene: Employees should be trained in proper hygiene practices and must follow good personal hygiene practices such as hand washing and proper attire to especially in the production and laboratory settings.
Cleanliness of buildings and facilities: Buildings and facilities should be designed and constructed to facilitate cleaning and to prevent external contamination or cross-contamination between different products within the facility.
Equipment and utensils: Equipment and utensils should be designed, constructed, and maintained to facilitate cleaning and prevent contamination.
Production and process controls: Companies should establish and implement written procedures for production SOPs and protocols and process controls to ensure that the products are safe, unadulterated, and possess the characteristics they purport.
Sanitation: A sanitation program should be in place to ensure that food contact surfaces and equipment are properly cleaned and sanitized to prevent contamination or cross-contamination. The written Sanitation SOP (SSOP) is the compliance guide to which the sanitation logs show whether or not the company is compliant.
Pest control: Companies should establish and implement a pest control program to prevent pests in the facility that can undermine food safety.
Hazard Analysis and Critical Control Points (HACCP): Companies should conduct a hazard analysis to determine the potential food safety hazards associated with their products and implement measures to control those hazards. HACCP is a key component of GMP and often takes the most attention and effort to implement.
Allergen control: Companies should implement measures to control allergen cross-contact in the facility and be able to identify and label any allergens used in food products.
Recall plan: Companies should establish and implement a recall plan in the event of product contamination or other safety issues per USDA or State Agriculture Department Regulations.
Record Keeping: Companies should maintain accurate and consistent records to demonstrate compliance with GMP regulations and to facilitate both internal and external audits into any food safety issues that may arise.
Raw Material Control: Companies should establish and implement procedures to ensure that raw materials and ingredients used in food production are safe, of the appropriate quality, and suitable for their intended use. This includes procedures for receiving, inspecting, testing, and storing raw materials.
Training and education: Companies should provide training for all employees on the importance of food safety, GMP principles, and their role in ensuring the safety of food products.
Product Identification & Traceability: Companies should be able to identify and trace each batch and/or lot of product through all stages of production, packaging, storage, and distribution. Traceability helps in preventing and quickly recalling contaminated or mislabeled products.
Quality Control: Companies should establish and implement a comprehensive and actionable quality control program to ensure that the products are safe and meet all the standards for identity, strength, quality, and purity. This includes regular testing and monitoring of products to ensure they meet all specifications.
Maintenance and Calibration: Companies should establish and implement procedures to ensure that equipment and instruments are properly maintained, calibrated, and in good working order. Furthermore, they should establish procedures for the periodic maintenance of buildings and facilities.

Benefits of GMP Certification

Here are six key benefits of acquiring GMP certification:

Benefit 1. Competitive Market Advantage:

GMP certification enhances a company’s market reputation by demonstrating a commitment to producing safe, high-quality products that meet universally accepted standards.
Consumers and businesses prefer to purchase from GMP-certified organizations; some even require it from their suppliers.

Benefit 2. Prevention of Costly Issues:

Helps avoid expensive and time-consuming problems, such as product recalls, by ensuring compliance with GMP standards.
Establishing GMP compliance processes reduces the risk of contaminants and legal issues, protecting the company’s reputation and finances.

Benefit 3. Legal and Regulatory Compliance:

Supports adherence to various legal standards, such as the U.S. Food Safety Modernization Act (FSMA), which mandates GMP compliance for food producers.
Aligns with EU Food Hygiene Regulations and other international standards, proving compliance across different jurisdictions.

Benefit 4. Adaptation to Country-Specific Standards:

GMP requirements can vary by country, with unique standards, regulations, and certifying bodies.
Companies must conduct thorough research on the specific GMP regulations and certification standards in the countries where they operate or plan to operate.

Benefit 5. Continuous Improvement of Production Processes:

Gaining GMP certification requires adjustments to production procedures, passing on-site inspections, and conducting a thorough review of current processes.
Businesses must continuously evaluate and improve their production practices to maintain compliance and uphold the certification.

Benefit 6. Enhanced Consumer Confidence and Trust:

GMP certification signals to consumers that the company prioritizes product safety, hygiene, and quality, boosting customer loyalty and trust.

GMP and Link With Other Certifications

In addition to gaining globally accepted standards of safety and quality, obtaining GMP certification can also simplify obtaining other notable product certifications for your company. Here are a few of them:

1. ISO 9001 (Quality Management Systems):

ISO 9001 focuses on overall quality management principles, emphasizing customer satisfaction, continuous improvement, and systematic processes. GMP aligns closely with these principles, specifically targeting the manufacturing aspects. Achieving ISO 9001 alongside GMP shows a comprehensive commitment to both quality and safety, bolstering the company’s operational excellence.

2. HACCP (Hazard Analysis and Critical Control Points):

HACCP is crucial for food safety, identifying critical points in production where contamination can occur. While HACCP focuses on food safety, GMP covers broader manufacturing practices, including equipment maintenance, employee hygiene, and overall facility management. Together, they ensure a robust approach to food safety and quality, often required in food and beverage industries.

3. BRCGS (Brand Reputation through Compliance Global Standards):

The BRCGS standard focuses on food safety, quality, and operational criteria. It requires compliance with GMP as a baseline, ensuring that products are manufactured in a safe and controlled environment. Being certified in both BRCGS and GMP strengthens a company’s position in the global market, especially in food and beverage sectors.

4. Halal Certification:

While not a substitute for GMP, this is still very important, as halal is the only single certification that opens up access to over 2 billion consumers globally. Halal certification follows Islamic dietary laws, which includes many elements of GMP certification, which confirms that a business’ production procedures adhere to rules for food safety and sanitation. Food and beverage businesses may shorten the process of acquiring Halal certification, making it easier and more productive, by gaining GMP certification ahead of time.

You can learn more about halal certification here.

Download our Free GMP Checklist!

From minimizing risks and avoiding costly product recalls to enhancing your reputation and gaining a competitive edge, the benefits of GMP certification are significant.

Download this free GMP checklist for food industry to kick-off your compliance with this central product safety & quality standard!

Frequently Asked Questions (FAQs)

Q1. Why Is GMP Certification Important?

GMP certification is important because it ensures the safety, quality, and consistency of products. It helps companies avoid costly recalls, meet regulatory requirements, and build trust with consumers and business partners.

Q2. How Do I Get GMP Certified?

To get GMP certified, companies must evaluate their manufacturing processes, make necessary adjustments to meet GMP standards, and pass an on-site inspection by a recognized certifying body.

Q3. How Long Is GMP Certification Valid?

GMP certification is typically valid for 1 to 2 years, after which companies must undergo a re-certification process to ensure ongoing compliance with GMP standards.

Q4. What Are GMP Compliance Requirements?

GMP compliance requirements include quality management, proper hygiene, controlled manufacturing environments, accurate record-keeping, staff training, and effective quality control measures.

Q5. Can Small Businesses Get GMP Certified?

Yes, small businesses can get GMP certified. The certification process is scalable, and smaller companies can adjust their practices to meet GMP standards, which can help them grow and compete in larger markets.