Food safety

GMP Certification Guide: How to Get GMP Certified in 6 Steps

Use this thorough yet simplified guide to start your GMP certification journey on the right foot.


Use this thorough yet simplified guide to start your GMP certification journey on the right foot.

If you’re wondering how to get GMP certified, begin with a thorough analysis of your quality systems and computer systems to ensure they comply with Good Manufacturing Practices standards, especially in terms of documentation, data integrity, and system security.

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Next, conduct detailed inspections of your manufacturing facilities and equipment logs to verify that the physical environment and machinery meet the required operational standards.

Finally, review the qualifications and training of all personnel to confirm they are capable of performing their duties according to GMP regulations, culminating in a final assessment by the certifying body to decide on certification.

Key takeaways

  • GMP certification ensures that manufacturing facilities meet high safety and quality standards through a third-party audit process.
  • The certification process begins with a thorough analysis of quality and computer systems, focusing on documentation, data integrity, and system security.
  • Detailed inspections of manufacturing facilities and equipment are crucial to verify that they meet GMP operational standards.
  • Personnel training and qualifications review confirms that all staff can perform their duties in compliance with GMP regulations.
  • GMP certification must be renewed every three years to maintain compliance and continue meeting industry standards.
  • Pre-audit readiness involves ensuring all GMP compliance requirements are met, likened to studying for a test to ensure success.
  • Factors such as facility size, production complexity, and the chosen certifying body significantly impact the cost of GMP certification.
  • Streamlining the certification path involves leveraging technology, standardizing procedures, and investing in ongoing staff training.
  • GMP certification is not just a regulatory requirement but a mark of quality that enhances product credibility and consumer trust.
  • Using FoodDocs food safety management software can greatly facilitate daily task management, operational compliance, and regulatory requirement maintenance.

 

What is GMP certified? What is GMP certification?

Being GMP certified means that your manufacturing facility has attained a Good Manufacturing Practices certification as a result of passing a third-party GMP audit that guarantees you meet all the compliance requirements. Failing to meet these requirements will result in a list of GMP violations that must correct before becoming certified.

How long does GMP certification last?

A GMP certification lasts three years, on average. After that period, manufacturers must renew their GMP-certified status with another third-party audit from a certification body.

 

What are the GMP certification requirements?

You can schedule your third-party audit whenever you want. However, we recommend that the food manufacturers we speak with first ensure that they’re satisfying GMP compliance requirements.

Think of it like a “practice round”. There’s little point in writing a test you didn’t study for. To manufacture food products with high safety and quality standards, do what you can to meet these GMP requirements:

Facility and equipment

Ensuring the safety and integrity of products starts with the design and maintenance of facilities and equipment. They must be specifically constructed to eliminate risks of contamination, cross-contamination, and errors. This means carefully planning the layout of the facility to promote a logical flow of materials and personnel, which helps minimize mix-ups.

Operationally, equipment must be not only operated according to established procedures but also regularly maintained and calibrated (e.g., thermometers or meat slicers). This ensures that equipment functions properly and any discrepancies are quickly addressed so that teams can consistently produce high-quality products.

Personnel

The backbone of any manufacturing operation is its team. Every individual involved in manufacturing must be thoroughly trained and qualified for their specific roles. This training includes a deep dive into GMP principles, job-specific duties, and staying updated with industry standards.

It's also crucial that each employee understands their specific responsibilities and the critical role they play in maintaining product quality and safety. This awareness is key to fostering a food safety culture of compliance and excellence.

GMP certification auditor talking to food manufacturing plant worker about compliance.

Documentation and records

A secure and robust system for documentation and records is essential for compliance with GMP standards. Manufacturers must maintain comprehensive documentation that describes all procedures and specifications involved in the manufacturing process in detail.

You must also ensure accurate and up-to-date records of each production batch. These records should detail the process, testing, and any deviations from standard procedures, and they must be readily accessible for auditing purposes. This level of detail supports transparency and traceability throughout the manufacturing process.

Quality control

Quality control is a critical pillar in manufacturing. A rigorous quality control system must be in place, encompassing testing of all raw materials, in-process materials, and finished products.

These tests are designed to verify the identity, potency, purity, and quality of each item, adhering strictly to predefined standards and specifications. This level of meticulous testing ensures that every product consistently meets the required quality criteria before reaching the consumer.

Complaint handling and product recall

Effective systems for complaint management and product recall are non-negotiable. Manufacturers must have procedures in place for efficiently receiving, reviewing, and addressing customer complaints to ensure that issues are resolved promptly and effectively.

Your business should also have a clearly defined process for product recalls. This includes thorough investigation, execution of the recall, and timely notification of regulatory authorities.

Food production line at a GMP-certified facility.

How to get GMP certified (in 6 steps)

1. Analysis of quality systems

The first step in obtaining GMP certification involves a thorough analysis of your existing quality systems to ensure they align with GMP requirements. This includes evaluating your quality control procedures, documentation practices, and overall compliance with industry standards. It’s essential to identify any gaps or areas for improvement that could hinder certification.

2. Analysis of computer systems

Ensuring that your computer systems are reliable, secure, and capable of maintaining the integrity of data is crucial. The second step examines the software and hardware used in production and quality control to verify that they meet GMP standards, particularly in terms of data accuracy and traceability.

3. Manufacturing facilities analysis

The third step involves a detailed inspection of your manufacturing facilities to ensure they meet the physical conditions required by GMP. This includes the layout and design of the facilities, air and water quality control, and the maintenance of a clean and hygienic manufacturing environment.

4. Equipment log review

Reviewing equipment logs is critical to ensure that all machinery used in the manufacturing process is suitable for its intended purpose and is regularly maintained and calibrated. This fourth step checks for consistent performance and compliance with operational standards.

5. Personnel review

The fifth step assesses the training and qualifications of all personnel involved in manufacturing to ensure they are capable of performing their duties according to GMP standards. This includes evaluating training records and ensuring that ongoing training programs are in place.

6. Final decision

The sixth and final step in the GMP certification process is the decision made by the certifying body based on the analysis and reviews conducted. This decision will determine whether your company is granted GMP certification or if further improvements are required.

How to get GMP certified in six steps.

How long does it take to get GMP certification?

It can take up to 12 months to become GMP-certified and as little as three months, on average. Of course, this depends on the complexity of your manufacturing company’s specific operations and how many of your existing processes need (or need not) to be changed.

How much does GMP certification cost?

GMP certification can cost anywhere from $10,000 and $50,000. The price range varies so widely because key factors that influence cost do, too.

For example, factors that can impact the cost of GMP certification include:

  • Size of the facility: Larger facilities often have more extensive operations and complex logistics, which can increase the certification cost due to the greater volume of processes and transactions that need to be evaluated and monitored.
  • Complexity of production: The intricacy of the production process plays a significant role in determining costs. More complex production setups require more detailed assessments and controls, which can elevate the overall expenses.
  • Certifying body: Costs can also differ depending on the certifying body chosen. Each organization may have its own pricing structure, reflecting their reputation, the scope of their audits, and the services they provide.
  • Number of locations: Companies with multiple manufacturing sites must undergo assessments at each location, which multiplies the costs as each site requires individual evaluation for compliance.
  • Types of products: The nature of the products being manufactured can influence the cost. Products that require more stringent controls, such as pharmaceuticals or food items, can lead to higher certification expenses due to the need for more rigorous safety and quality checks.
  • Risks associated with activities: The level of risk involved in the manufacturing activities also impacts the cost. Higher risk processes necessitate more comprehensive monitoring and control systems to comply with GMP standards.

The cost of getting GMP certified and six factors that can impact the total cost.

What are some additional costs associated with GMP certification?

In addition to the factors listed above, here are some other areas that might incur further costs:

  • Consultant fees: Hiring experts for gap analysis to identify areas needing improvement before the GMP audit can be costly.
  • Employee training programs: Training staff to comply with GMP standards incurs expenses related to developing and delivering training.
  • Equipment upgrades or replacements: Ensuring equipment meets GMP standards might require significant investment in upgrading or replacing existing machinery.
  • Internal auditing expenses: Internal GMP audits are crucial for maintaining GMP compliance and can add to the overall cost due to the need for ongoing evaluation and monitoring.

How can you simplify the path to GMP certification?

You can simplify your GMP certification journey by:

  1. Leveraging technology: Implementing a specialized digital food safety management system can help automate documentation, manage quality controls, and maintain compliance logs, reducing manual errors and saving time.
  2. Standardizing procedures: Establish clear, standardized procedures for all aspects of production and quality control to ensure consistent compliance with GMP standards across all operations.
  3. Investing in training: Continuously train personnel to keep them updated on GMP standards and practices, which can prevent compliance issues and streamline the certification process.
  4. Conducting pre-audit checks: Regularly schedule internal audits to identify and address non-compliance issues before the formal certification audit, minimizing the risk of failing the GMP assessment.
  5. Engaging consultants: Consider hiring consultants who specialize in GMP certification to provide expert guidance and help navigate the complexities of the certification process effectively.

In today’s age, using technology is by far the most effective way to maintain food safety compliance — especially at scale. Check out our guide on how to buy food safety management software and keep reading to see how FoodDocs can help your business.

Five things you can do to simplify your path to becoming GMP certified.

What’s the easiest way to get GMP certified?

The easiest way to get GMP certified is to use food safety management software that helps manufacturers easily complete daily tasks, monitor operational compliance, and maintain regulatory requirements.

In addition to FoodDocs, some common GMP compliance software vendors for SMEs are:

Whatever software you choose, it should support your GMP-aligned needs.

Here’s how FoodDocs can help prepare you for GMP certification

Implementing an easy and intuitive food safety management software will help save businesses time, money and, more importantly, from non-compliance.

Preview of the digital food safety cleaning checklist in FoodDocs' mobile app.

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Securely store food safety documents and records

GMP standards mandate thorough and accurate documentation. FoodDocs stores every monitoring and traceability log you record, ensuring that all essential records are readily accessible for audits.

The food safety management software also safely stores documents such as your HACCP Plan, Standard Operating Procedures, Prerequisite Programs, training certificates or food handler cards, and any other critical documents your business requires for GMP compliance.

Example of the FoodDocs cloud storage for easy access to food safety files.

Automate task notifications with built-in corrective actions

When setting up FoodDocs’ digital food safety system, you can assign role-based tasks to specific team members. Every day, they’ll get automatic notifications in the mobile app for their responsibilities.

Let’s take a temperature check or receiving log, for example. Digital monitoring checks include corrective actions so if an employee completes that task but something is out of range (i.e., temperature’s in the danger zone or a shipment was damaged), an immediate prompt will guide your team on how to respond, ensuring food safety and saving time on training.

Preview of the corrective actions setup screen in the FoodDocs mobile app.

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Increase efficiency while reducing human error

FoodDocs’ smart mobile app offers a time-saving, pre-filling solution. It fills in monitoring checks automatically according to previously inserted data. All you need to do is confirm the logs or change them.

This saves your team’s time on repetitive activities and enables you to focus on the most important things in your kitchen. Other features such as auto-calculating shelf-life dates further enable employees to work faster and smarter toward GMP compliance.

Two-in-one traceability log txt

Support training and improve accountability

If you’re striving to be GMP certified, your daily food safety management tasks should reflect that goal. FoodDocs allows you to use pre-set or customized step-by-step instructions for every single task in your system. You can even add photo or video examples of what completing the task successfully looks like (e.g., a cleaned stock room or good versus bad shipment).

What this does is effectively help train employees on-the-go. By all means, have regularly scheduled team-wide training. But in an industry that requires and rewards continuous improvement, FoodDocs’ step-by-step instructions is an easy way to increase knowledge and improve accountability when it comes to GMP compliance.

Step-by-step_instructions

Prepare teams for third-party GMP audits

Managers can access FoodDocs’ real-time overview dashboard. This is a great way to get a high-level view of your present-day GMP compliance. If it’s not trending well, you can easily create an internal GMP audit and conduct a mock walkthrough with your team.

Completing this audit — successfully or not — will give your team a clearer picture of which aspects of the GMP audit they need to improve before the real thing. Is it in personal hygiene? Processes and controls?

Plus, an ongoing record of the internal audits you’ve run is a great way to prove to third-party auditors or inspectors that you’re always trying to improve your GMP compliance.

Food_safety_audit

Ultimately, FoodDocs helps everyone from managers and supervisors to food handlers save more time so they can focus on the product and the customer.

Improve traceability and recall management

Traceability logs are simple too, taking only three taps: select the product by searching for it manually or using a built-in mobile scanner to make the process faster thanks to EAN/QR codes. Then enter the supplier name, invoice number, and an image of your invoice as proof and quality control fields if necessary.

FoodDocs’ Traceability system helps to track your ingredients and food items through all stages of production. You can even complete traceability logs and attach monitoring tasks to the same product batch right away. Simply log important quality checks like the cooking temperature of the prepared batch during the preparation process.

This ensures necessary traceability and visibility in case of a recall or customer complaint and will help you ensure high-quality food safety.

Whether recalls or customer complaints, a digital traceability log also makes it possible to find a product’s historical data for your local authority or auditor in seconds. You can easily search by product, batches, ingredient, or expiry date (which are automatically calculated) to prove compliance.

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Frequently asked questions about GMP certification


Who needs a GMP certificate?

Companies in the manufacturing sectors of food, pharmaceuticals, cosmetics, and dietary supplements need to ensure their products are consistently produced and controlled according to quality standards.

Who gives GMP certification?

GMP certification is issued by third-party organizations that specialize in auditing manufacturing processes against set GMP standards.

What is a GMP-certified facility?

A GMP-certified facility is one that has been audited and certified to meet the specific standards required under Good Manufacturing Practices, ensuring products are made safely and in compliance with regulations.

Is GMP certification good?

Yes, GMP certification is highly regarded as it demonstrates a commitment to quality and safety in manufacturing processes, enhancing product credibility and consumer trust.

How to check GMP certification?

GMP certifications can be verified by checking with the issuing certification body, or by viewing the certification details typically displayed on the manufacturer’s website or directly on product packaging.

Is there a GMP certification course?

Yes, there are various GMP certification courses available that provide training on the GMP guidelines, procedures, and compliance strategies for individuals and companies in relevant industries.

What are the 5 GMP requirements?

The five key GMP requirements typically include:

  1. Quality management: This involves setting up comprehensive systems that ensure all manufacturing processes are designed and monitored to maintain high quality standards throughout production.
  2. Premises and equipment: Facilities and equipment must be appropriately designed, maintained, and cleaned to prevent contamination and ensure consistent product quality.
  3. Documentation: Detailed records must be kept for every aspect of the manufacturing process, from raw material procurement to final product distribution, ensuring traceability and compliance.
  4. Production: Production processes must be clearly defined, validated, and followed, with controls in place to ensure that each product batch meets established quality specifications.
  5. Quality control: Ongoing testing and verification must be conducted to ensure that materials, in-process batches, and finished products comply with predefined quality criteria.

 

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