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Good Manufacturing Practices: What is GMP audit and how to get gmp certified easily?
Good Manufacturing Practices (GMPs) are requirements for higher food safety systems for food producers.
Good Manufacturing Practices (GMPs) are requirements for higher food safety systems for food producers.
All food safety programs are built on the foundation of basic food handling conditions. These basic conditions are more known as Good Manufacturing Practices (GMP). To ensure and maintain a consistent approach to food safety, federal authorities provide guidelines on regulatory actions for businesses to follow. In the entire food supply chain, GMPs are regulatory requirements for every food manufacturing business to ensure public health safety.
Key points covered:
- GMPs are food safety activities and guidelines that ensure the production of consistently safe and high-quality products.
- The 5 principles of GMP are People, Process, Premises, Products, and Procedures.
- Compliance with the GMP food protection principles is a continuous process that must be maintained throughout a company's operation as a commitment to protecting its consumers.
- Compliance with GMP guidelines requires training, food hygiene practices, sanitary operations, adequate maintenance of equipment, raw material handling, proper storage, allergen management, food testing, and regular audits.
- GMP training is mandatory for every food handler.
- A GMP certification program ensures that your business complies with minimum safety requirements.
- GMP certification requires you to conduct a gap analysis and establish a food safety management system.
- A GMP audit is the specialized process of evaluating your business operations based on GMP requirements.
- FoodDocs’ smart Food Safety Management System covers all the main principles of the GMP guidelines.
- Our smart software can generate digital monitoring tasks equipped with detailed instructions for food safety compliance and training.
- FoodDocs’ Food Safety System comes with a comprehensive Traceability System that can help you record ingredients, finished food, and process flows in one cloud system.
- Our software features a built-in HACCP plan builder to create a comprehensive HACCP plan template based on your business profile.
This article discusses good manufacturing practices and their importance for food businesses. Understand more about how FoodDocs' smart Food Safety Management System can help you secure a GMP audit and become certified easily.
WHAT WE'LL COVER:
- GMP in the food industry
- Five components of GMP
- Compliance with GMP requirements
- GMP guidelines for food manufacturers
- GMP food safety training
- GMP certification
- How to get GMP certified?
- GMP audit
- How to use FoodDocs for easy GMP compliance?
- Customizable monitoring tasks
- Step-by-step instructions
- Smart auditing tools
- Two-in-one Traceability System
- Built-in HACCP plan builder
What does GMP in the food industry mean?
GMP (Good Manufacturing Practice) in the food industry is a set of guidelines provided by federal agencies for food businesses that will help them ensure food safety throughout the production process.
The guidelines cover all aspects of production and food handling, including cleanliness of the entire facility, employee hygiene, and handling of raw materials and finished products.
Some good examples of GMP include the following:
- Creating standard operating procedures (SOPs) or step-by-step instructions for the different aspects of food production.
- Inspecting process materials for safety and quality systems.
- Preventing contamination of food.
- Ensuring that the food facility design meets regulatory authority's standards.
- Establishing an allergen program.
- Establishing a product recall program.
- Ensuring proper food labeling and packaging instructions.
- Training food handlers with proper hygiene and principles of food safety.
- Establishing a traceability system.
- Establishing a comprehensive system for compiling batch production records.
- Ensuring proper cleaning and sanitizing of all equipment and food contact surfaces.
- Establish a monitoring system for safety and quality control operations in food manufacturing facilities.
In general, GMP guidelines are established to ensure the minimal conditions needed in a food facility to produce safe and high-quality products. It sets the proper working conditions for a food business and manufacturing facilities where instances of contamination by potential hazards are significantly limited.
GMP can be very specific regarding the operations involved in a food manufacturing process.
Ensure that your business has covered every requirement on the GMP guidance documents with FoodDocs' smart Food Safety Management System.
Switch to a digital platform for monitoring your GMPs daily. You can get automatically generated monitoring tasks built based on your operations. Our system also comes with a built-in Traceability System, a recall log, and a production management system for managing your everyday operations.
In addition to comprehensive Food Safety Software, FoodDocs features a built-in HACCP plan builder that can automatically generate detailed GMP documents based on your business needs. Fulfill all prerequisite documents for establishing a HACCP system with the help of our smart software.
Who developed GMPs for food production?
Good Manufacturing Practices (GMPs) were first developed by the U.S. Food and Drug Administration (FDA) in the mid-1960s for food and drug manufacturers.
The main objective of the GMP during its first years of conceptualization was to describe rules for creating and maintaining food safety and sanitation for all food processing facilities and pharmaceutical production.
The GMP guidelines were also established to support guidelines of the FDCA, specifically Section 402(a)(3), which specifies the sanitary conditions for producing food and medicinal products.
After a series of improvements to the original guidelines and relevant food legislation, the FDA established a Food GMP Modernization Working Group to evaluate the effectiveness of the most current GMP. This move by the FDA aims to consistently improve on the existing laws and ensure regulatory compliance in control of manufacturing processes.
The GMP guidelines apply to food and pharmaceutical manufacturers reporting under federal agencies.
What are the 5 main components of Good Manufacturing Practice?
If you are new to the food industry and you need a quick understanding of the guidelines under the GMP, then all you need to do is familiarize yourself with its main components.
Guidelines regarding food handlers involve their proper food safety training and education in executing proper food handling techniques. Every employee in a food business must be familiar with the principles of basic hygiene requirements.
Under the GMP guidelines, all employees must be provided with clear roles and responsibilities for maintaining food safety. The guidelines also require regular assessment of the employee's knowledge of food safety and handling practices.
You could use FoodDocs' free Food Safety Quiz to evaluate your team's knowledge of food safety.
Processes cover the need for every food business to conduct all necessary food safety practices and follow all applicable regulations for the protection of food from contamination sources. Food safety procedures involved in this principle include ensuring proper temperatures during cooking and ensuring sanitary facility conditions.
The process component also focuses on establishing a proper documentation system for food manufacturing operations. The system will help prove your manufacturing operation's compliance with food safety regulations.
Like employee training, food safety processes require regular evaluation to ensure efficiency and effectiveness. Upon evaluation, food safety managers can form better strategies for improvement.
Every food business must ensure that every food facility, including equipment, is well-maintained and in clean condition to guarantee safety and effectiveness in performing their functions. One of the main goals of this component is to ensure that every product that your business produces is of the same quality and safety and that operational issues are controlled.
The premises component can be achieved by establishing portable equipment maintenance, adequate sanitation principles, and schedules. These food safety activities can help control any source of contamination and protect consumers from health hazards, such as undesirable microorganisms or foreign substances.
The GMP guidelines ensure control of products by establishing guidelines for evaluating them during receiving and storage. This component aims to ensure that all materials used in your food business are free from contamination to ensure safe and high-quality food products.
Procedures or Paperwork
Procedures refer to the comprehensive documentation of all safety operations under the GMP guidelines. This component is critical for ensuring that all operations result in consistent quality and safety of products. It includes the compilation of accurate records such as the following:
- laboratory control records
- distribution records
- process records
- training records
- batch production records
Document procedures and complete records will help you discover non-compliance.
The key to covering all 5 Ps of GMP is to implement a comprehensive Food Safety Management System (FSMS). This system covers all areas and helps document all critical information. It also helps ensure that food handlers perform their responsibilities correctly and efficiently.
To improve the accuracy and efficiency of your analytical reports, use our digital solution instead of the traditional monitoring system. Using our smart Food Safety Management System, you can get intuitive features powered by artificial intelligence.
Our system can generate essential food safety monitoring logs and help you perform them with a notification system. In addition, our software features a two-in-one Traceability System that can also help you manage production operations.
Keep all product and process information in one comprehensive Traceability System and access important information in one cloud system. Our Traceability System features advanced search options that can help you gather particular information with specific filters.
How to comply with GMP requirements?
Despite the many complex guidelines included in the GMP, food businesses are required to follow its guidelines. Following GMPs is a prerequisite for establishing safe working conditions in the food industry.
All food businesses are required to be knowledgeable about the GMP guidelines and must consistently be able to apply them.
Here are some essential steps to help your food business company comply with GMP:
Train employees. All food handlers must be properly trained and secure minimum qualifications for food handling. Employees must be familiar with standard operating procedures and regularly assessed to ensure that they retain compliance with minimum industry standards. Appropriate training records should accompany all training procedures.
Observe the personal hygiene of staff. The GMP is all about maintaining sanitary working conditions. Simple personal hygiene practices are a must at all times. Food handlers must learn how to properly wash their hands, wear proper protective clothing, and maintain good health in and out of the establishment.
Equipment and facility cleanliness. You must ensure the cleanliness of premises based on a plan and design elements that will minimize the risk of contamination. The materials and layout of the facility must be easy to maintain and will not harbor contaminants. In addition, proper cleaning and sanitation guidelines for food or food contact surfaces must always be prepared.
Raw material and product handling. You must provide guidelines for the proper handling and control procedures for both raw materials and finished products. This includes raw material procurement, storing, processing, packaging, and the delivery of foods. The aim is to ensure that any contamination is reduced or at least controlled to a minimum.
- Monitoring and testing. You must consistently and regularly monitor the quality and safety of their products with detailed procedures. This objective is achieved by evaluating if processes and their intended results are being achieved. Results are then recorded for evaluation.
Record keeping. All processes must be properly recorded as proof of compliance with GMP standards. Establish a comprehensive monitoring system to capture your operations' essential information and batch records for safety and quality-related documents.
- Audits. Conduct internal food safety audits and review documents to verify whether your food safety management system is enough to ensure compliance with the GMPs. Regular audits help prepare your team for actual inspections of manufacturing sites by health departments.
There are many different critical steps to achieve GMP compliance. The main thing to remember is that the objective of GMP is to ensure sanitary conditions for food production. Invest in establishing a comprehensive food safety system to ensure compliance with GMP requirements. Establishing risk-based preventive controls involves a significant part of GMP compliance.
GMP-compliant businesses have a competitive advantage over other companies. Compliance also means quality assurance and meeting customer expectations.
What are the main GMP guidelines for food manufacturing?
GMPs may vary in applicability depending on the nature of your food business. In addition, variations may also be observed depending on the specific type of food product and the regulatory requirements of the country or region in which the food manufacturer operates.
Below, we listed some basic operations and GMP for food manufacturing that will help you secure compliance:
- Train employees on proper personal hygiene, including the following tasks:
- do not allow sick employees to work;
- provide adequate supplies for hygienic practices (e.g., soap, warm water, brushes); and
- provide gear for the physical protection of employees (e.g., hair nets and uniforms).
- Create step-by-step instructions on how to perform particular tasks (e.g., Standard Operating Procedures). Establish detailed procedures for:
- Establish a systematic approach for recording all observations of food safety procedures.
- Validate records to ensure that your food safety plan helps you comply with GMP requirements.
- Implement control plans for our business (e.g., recall plan, allergen management plan, pest control plan, waste management plan, and traceability).
- Establish a regular cleaning and sanitation schedule to avoid food contamination.
- Apply your own assessments and findings during your internal audits.
- Achieve GMP certification from accredited certification bodies.
In addition, food manufacturers should consult the relevant regulatory authorities and stay updated on any changes in GMP requirements to ensure compliance.
What does GMP food safety training contain?
GMP training is a critical process to achieve the objectives of the program. It ensures that every employee understands the importance of GMPs and that they can perform the tasks as needed. GMP training is needed to reduce the risk of causing food poisoning, consistently improve food safety skills, increase productivity, and become compliant with higher food safety standards.
Here are a few topics that are included in GMP training:
Introduction to GMP. Includes the introduction of the regulation's history, importance, potential consequences of non-compliance, public health significance, and food safety importance.
Quality Management System (QMS). This topic includes how to properly document food safety operations and achieve consistency in quality assurance and meeting customer specifications and expectations.
Facility and Equipment Design. This section covers the importance of facility layout, design specifications, and the flow of foods in reducing the reasonable possibility of contamination. It includes identifying proper facility designs that will help prevent dirt and food accumulation. The section also introduces proper basic operations in maintaining the sanitized condition of a food production facility.
Personnel Training. GMP training will determine the contribution of every employee in complying with food safety operations. The training program will also help train employees to address problems, such as cases of cross - contamination or cross - contact.
Material Control. Employees will be trained on how to receive, store properly, and control stocks while maintaining food safety.
Packaging and Labeling. This section will provide an overview of the importance of proper packaging and labeling, as well as using appropriate food packaging materials and including accurate statements or claims in maintaining food safety.
Quality Control. In this part, GMP training will highlight monitoring tasks that will ensure the sanitary quality of food products before release. This includes correct procedures for sampling and test methods for analysis.
Recordkeeping and Documentation. Participants will be trained on properly documenting monitoring information, which information to capture, sample retention policies, and proper archiving.
The main objective of GMP training is to prepare every food business personnel involved in handling foods to maintain food safety and protect public health.
The program also prepares participants on how to address food safety and quality issues.
Employees who have finished GMP training will be awarded a certificate as proof of completion. All new employees are required to have proper GMP training. Furthermore, the training program must be refreshed annually or biannually, depending on the performance of the food safety team.
What is the GMP certification?
GMP certification proves that a food business complies with the current standards under the GMP regulations. A private third-party certification body awards a GMP certificate to a food industry establishment that has passed several inspections.
The GMP certification procedure aims to ensure your business's commitment to food safety while ensuring the consistency of food products. Obtaining a GMP certification requires intensive preparations. A typical certification procedure starts with an on-site GMP inspection approach of your production facility and a review of your records and analytical reports.
Businesses that pass a GMP compliance inspection are more likely to be trusted by consumers. GMP-certified businesses are also less likely to face food safety and related problems.
A GMP certificate is awarded to a food business for passing the GMP inspection approach. The certification decision is awarded by a competent authority accredited by federal agencies.
This document is typically valid for a maximum of 2 to 3 years and will require renewal.
Who needs to be GMP certified?
In the US food industry, all food businesses that handle, store, manufacture, pack, and deliver foods for human consumption must secure a GMP certification. This serves as proof that your business has the appropriate process controls that will reduce risks to product quality and safety.
GMPs are considered prerequisite programs for establishing comprehensive food safety plans, such as the Hazard Analysis Critical Control Point. Compliance with GMP certification requirements makes HACCP establishment easier and more efficient.
If you are running a food business and need an effective Food Safety Management System to document your GMP operations, then you are in luck. Use FoodDocs' smart Food Safety Management System Software that can help you intuitively solve compliance problems. Get automatically generated monitoring logs just by providing your business operation information to our system.
How to get GMP certified?
The GMP certification procedure requires comprehensive preparation. It involves several steps and an extensive amount of time to prepare for the certification process.
Your business must comply with the guidelines in everyday operations and documentation procedures.
To help you prepare, follow these steps to get GMP certified:
Identify the appropriate GMP certification program. Choose a program that is specific to the food industry and based on your location.
Conduct a gap analysis. Identify areas that do not adhere to the current GMP guidelines.
Develop and implement GMP policies and procedures. Once analyzed, address non-compliance and train employees to maintain the guidelines consistently.
Establish a management system. Choose a food management system that covers all areas of your production system and can collect and present the information efficiently. Implement both quality and food safety management systems to satisfy customer requirements and ensure consistent performance.
Conduct a pre-audit. Test your team by conducting an in-house quality audit to address observed issues. Use this opportunity to collect all required analytical records for better presentation.
Schedule a certification audit. Once ready, contact the accreditation body and schedule arrangements for inspections.
Pass the certification audit. Guide the inspector through your continuous production operations and present your documentation accordingly during the GMP compliance inspection. The certification decision will be awarded after complying with any points for improvement.
Maintain certification. Ensure consistent compliance by regularly evaluating operations, maintaining complete records, and immediately addressing issues that may arise.
A GMP-certified status is just the first step to securing food safety. Compliance with GMP standards is a continuous commitment that requires extensive and consistent monitoring and evaluation. Compliance cannot stop once the certification is secured.
Maintaining GMP compliance not only provides a competitive advantage but also helps in preparing your business for higher-level food safety systems.
To help you evaluate your preparedness for a GMP certification process, use FoodDocs' smart Food Safety Management System, which features internal auditing tools. Use these intelligent features to create an extensive auditing list of the key areas of a GMP certification process and access them through our mobile food safety app.
Conduct in-house audits and use the information you gather to evaluate your preparedness for a GMP certification. Immediately communicate points for improvement to your team as you detect them using this tool.
What is a GMP audit?
GMP audit refers to the comprehensive review that an accrediting body conducts to ensure that a food company's processes, documentation, materials, and food processing facilities are compliant with the GMP standards. A GMP audit can be done by a federal agency, such as the FDA, or by a private third-party accreditation body for certification.
The audit aims to review whether the company complies with the established GMP standards or not. The audit includes an on-site evaluation of processes and a comprehensive review of documents by inspection teams.
Under the GMP audit section, we go into detail with the following topics:
Audits can be done as a routine check by food safety agencies or as a response to a complaint. Routine checks can be unannounced, so food businesses are expected to be always prepared.
The audit is concluded with a comprehensive inspection report of areas for improvement that need to be addressed immediately within the period of time provided. The findings in a GMP audit and your audit score are very important in ensuring that a food business complies with food safety regulations.
How to conduct a GMP self-audit?
A GMP self-audit can help you evaluate your operations and prepare you for an actual audit, whether for a routine inspection or certification. The audit checklist can be part of your regular audit plan. Regular self-audits can help you maintain compliance proactively.
Here are the general steps for conducting a GMP self-audit:
1. Understand GMP guidelines. Ensure that all employees know and understand the GMP guidelines for manufacturing process facilities; this is always the first step.
2. Develop an audit checklist. If you've been previously inspected, you can use the checklist that the auditor used and adapt it to your operations. If not, then you can develop your own checklist with procedures for inspections based on the applicable GMP guidelines.
3. Gather documentation. All documents must be neatly compiled for an audit. Ensure that documents are completely filled and there are no inconsistencies. The more detailed the documentation system is, the better.
4. Review documentation and facilities. Before and after a self-audit, make it a habit to verify your documents and operations if they are compliant.
5. Identify areas for improvement. Always take note of areas that can be better improved. This is the point of conducting a self-audit.
6. Develop an action plan. Based on your findings and assessment of the problems, develop an action plan with effective measures to address the problems. Communicate any result to the concerned departments.
7. Implement corrective actions. Do not leave non-compliance findings unattended. Apply standard solutions immediately. Make sure that they become compliant before the re-inspection.
8. Repeat the audit. Similar to how a regular audit works, conduct a process validation to determine if the corrective measures were properly implemented and if the entire operation is GMP compliant.
The provided steps are basic components of any self-audit checklist. You can take the process a step further by adding more comprehensive audit tasks. Use the self-inspection report to prepare and improve your compliance with regulations further.
Through regular self-audits, your team can stay ready and remain compliant consistently.
Learn more about developing a GMP audit checklist and get a sample checklist in the next section of this article.
GMP audit checklist
To help you perform your own GMP audit, we made a comprehensive GMP audit checklist of the essential points for any GMP audit. Use this checklist to determine if your food business is GMP-compliant and ready for an audit.
GMP Audit Checklist from FoodDocs
Remember to apply corrective actions in case of non-compliance. You can improve this checklist by adding specific points that may be essential for your operations.
Consider adding points to your GMP audit checklist from our food safety tips.
How to use FoodDocs for easy GMP compliance?
Complying with the GMP guidelines is a steady job and must be maintained every day of your operations. GMP compliance is your company's first line of approach to protecting public health by ensuring that your team is working on clean and sanitized conditions.
Using FoodDocs' smart Food Safety Management System, you can get intuitive solutions that can help you stay compliant consistently.
With the following smart solutions, you can be ready for any inspection anytime:
- Customizable monitoring tasks to help maintain food safety compliance
- Step-by-step instructions to help train food handlers
- Smart auditing tools to help evaluate your operations
- Two-in-one Traceability System to help track and manage production flow
- Built-in HACCP plan builder to help establish a comprehensive food safety plan
Customizable monitoring tasks to help maintain food safety compliance
Monitor and record all task information with the automatically generated monitoring tasks that our system can provide. When you sign up, our system will generate all the essential monitoring checks to keep you GMP-compliant through the information you provide.
Some of the customizable logs and checklists that you can get include the following:
- Receiving chilled goods log
- Fridge temperature log
- Temperature log
- Employee hygiene checklist
- Master sanitation schedule
Customizable Temperature Log from FoodDocs software
Use these comprehensive monitoring tasks to record critical information and maintain a food-safe working environment in your food premises according to GMP requirements. Our software's monitoring tasks are designed to maintain optimum food safety according to critical standards, such as the GMP guidelines.
What makes these monitoring tasks more efficient is that you can customize them according to your business needs. As GMP guidelines may vary from one food business type to another, you can easily apply customizations to each task and tailor them according to your operations.
Step-by-step instructions to help train food handlers
Make GMP training programs easier and more efficient with the help of our software's step-by-step instruction tools. Each automatically generated monitoring task comes with detailed instructions on how to perform and monitor the task.
You can use this feature to train food handlers and remind them of the proper execution of tasks according to GMP guidelines. In addition, you can use these instructions to train new food workers and save time from conducting food safety training repeatedly.
Make employee training programs more tailor-fit to your business by uploading your own versions of the instructions. You can upload images or videos from your food business and make the instructions more understandable among your team members.
Step-by-step instructions from FoodDocs software
Smart auditing tools to help evaluate your operations
Conduct in-house GMP audits with the help of our smart auditing tools. You can get a comprehensive audit checklist from our software or create one according to GMP checklists from scratch. Use this feature to evaluate your food business's readiness for certification or any inspection.
Perform audits using our Food Safety App and use the results to further improve your operations according to your findings.
With the help of our smart auditing tools, you can always stay compliant with minimum GMP standards and consistently evaluate your system for optimization.
Two-in-one Traceability System to help track and manage production flow
One of the main requirements of every GMP guideline is establishing a comprehensive traceability system. With our intuitive Food Safety Software, you can also get an intuitive Traceability System with production management features.
Using our Traceability System, you can log all critical information about your food ingredients, products, and batch operations. Access information about a particular production batch with the help of advanced search options.
In case of customer complaints or food recalls, you can use our Traceability System to retrieve information about a particular production batch and print it as a reference. With quick solutions such as our advanced search feature, you can minimize damages caused by potential hazards.
Built-in HACCP plan builder to help establish a comprehensive food safety plan
As mentioned earlier, GMP is a comprehensive prerequisite program for more extensive food safety plans, such as a HACCP plan. Once you establish GMP guidelines for your business, the next compliance step is to create a HACCP plan.
FoodDocs can help you do both objectives in just a matter of 1 hour.
With the help of our built-in HACCP plan template builder, you can get a customizable, comprehensive HACCP plan complete with GMP documents.
Using our AI-powered software, you can get the following HACCP components:
- GMP and SSOP documents
- Basic flowchart of operations
- Hazard analysis
- Critical control points with critical limits
- Monitoring procedures
- Corrective action plan
- Verification procedure
- Recordkeeping procedures
HACCP plan template from FoodDocs software
Our intuitive software will tailor the generated HACCP plan based on your business profile. This means that all components will be tailored according to your operations and applicable business standards.
You can also customize the HACCP plan template to incorporate your unique operations or suggestions from certification bodies. Quickly apply corrective actions from inspection findings and achieve food safety compliance consistently.
GMP compliance focuses on proper documentation. With our smart solution, you can consistently ensure that important information is efficiently captured and that challenges for your business are always controlled.
Using FoodDocs' smart Food Safety Management System, your business can stay compliant with all food safety regulations and satisfy customers with consistent quality according to GMP requirements. Our system was built by food industry professionals and considered the most critical food safety standards essential for every food business.
Book a demo now and learn more about our food safety features.
Frequently Asked Questions (FAQs)
To help you understand more about gluten-free certification, here are a few of the most common questions asked regarding this topic:
Why does GMP in the food industry exist?
Good Manufacturing Practices help ensure that food products and medicinal products released in the market are consistent in terms of quality and safety.
These guidelines ensure that customers are safe from any foodborne illnesses as the products are produced in safe conditions.
GMPs are enforced by food safety agencies and health departments to protect public health through strict food safety criteria. The guidelines aim to create safe and clean working conditions for producing food and build stronger customer trust and brand reputation.
What does GMP stand for?
GMP stands for Good Manufacturing Practices. The acronym is a collective term for operational conditions needed to produce safe foods by food manufacturers.
What are Good Manufacturing Practices in the food industry?
Good Manufacturing Practices include any operation that ensures appropriate working conditions for handling and processing foods.
Examples of GMP food safety can include simple operations, such as training food handlers with the principles of food hygiene practices, establishing effective pest control programs, minimizing food contamination, and conducting adequate sanitation procedures. Basically, the guidelines include operations that will keep food safe.
What is GMP-certified?
GMP-certified is the status given to a food business that has been inspected and passed the evaluation on GMP standard compliance.
A GMP-certified food facility is a business that has been proven to produce safe and quality food products consistently.
How much does a GMP audit cost?
A GMP audit may cost nothing or up to a few hundred dollars, depending on the purpose of the audit. Generally, routine GMP audits conducted by the FDA do not cost anything, but reinspections due to violations may be billed. On the other hand, a GMP compliance inspection conducted by USDA-related agencies costs around $130 an hour.
If the GMP audit is performed as part of a certification process, then the cost may vary. Depending on the complexity of the certification process and the qualifications of the auditor, the entire process may start at $3,000 for a two-day audit. The cost may still increase depending on the compliance audit scope.