Good Manufacturing Practices (GMPs) are prerequisites for higher levels of food safety systems that food producers have ...
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Good Manufacturing Practices (GMPs) are prerequisites for higher levels of food safety systems that food producers have to follow.
All food safety systems 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 consistent safety and quality of products, federal authorities provide guidelines on regulatory actions for businesses to follow. In the food industry, GMPs are regulatory requirements for every food manufacturing business to ensure public health safety.
Compliance with the GMP standards is more than just a one-time thing. It is a continuous task that must be maintained throughout a company's operation as a commitment to protecting its consumers.
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.
Here are the major topics discussed in this article:
WHAT WE'LL COVER:
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, including cleanliness of the entire facility, employee hygiene, and handling of raw materials and finished products.
In this section, we discuss in detail the following topics on GMP:
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 health hazards are significantly limited. For example, GMPs establish food safety guidelines for properly sanitizing major equipment and utensils in between use to help prevent cross-contamination of food.
Another objective of GMP is to ensure that food safety practices are well-documented. This regulatory action helps in evaluating areas for improvement in food businesses or manufacturing sites. Compliance with GMP regulations can help prevent the release of defective products in the market.
GMP stands for Good Manufacturing Practices. The acronym is a collective term for operational conditions needed to produce safe foods by food manufacturers.
Good Manufacturing Practices are recognized within the food industry as minimum standard conditions for any food facility. These are minimum assurance for food safety inspectors and consumers that your food business is running under acceptable conditions.
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 proper hygiene for the manufacturing industry. Basically, the guidelines include operations that will keep food safe.
Some good examples of GMP include the following:
GMP can be very specific when it comes to the operations that they involve. All operations aim to minimize quality defects and food safety issues and serve as additional guidance for food businesses.
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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 GMP regulatory guidelines were developed because of unclear non-compliance violations from food safety laws, such as the Food Drug and Cosmetic Act (FDCA).
The main objective of the GMP during its first years of conceptualization was to describe rules for creating and maintaining sanitary conditions for all food processing facilities and pharmaceutical production. The GMP guidelines were also established to support statutory 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, 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.
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 to familiarize yourself with its main components.
The main components of the GMP can be summarized into the 5 Ps:
Guidelines regarding food handlers involve their proper food safety training in executing proper food handling practices. Every employee in a food business must be familiar with the principles and requirements of the GMP.
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.
This component emphasizes the need for every food business to conduct all necessary food safety practices and follow all applicable regulations to protect food from any source of contamination. The component also focuses on establishing a proper documentation system to 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 focus on ensuring that every food facility, including equipment, is well-maintained 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.
This can be achieved by establishing facility and equipment cleaning procedures and schedules.
The GMP guidelines ensure control of products by establishing guidelines for evaluating them during receiving and storage. This component ensures that all materials used in your food business are high-quality and will not affect the effectiveness of your food safety operations.
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:
Document procedures and complete records can efficiently help in determining 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.
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cGMP stands for current Good Manufacturing Practices.
Current Good Manufacturing Practices are stringent guidelines on food safety and quality and an up-to-date version of Good Manufacturing Practices (GMP). The cGMP specifically requires businesses reporting under the FDA to use up-to-date technologies and systems for compliance with regulations.
Below cGMP section, we discuss the following topics on cGMP:
Good Manufacturing Practices are general guidelines used by food, medical, and cosmetic businesses to manufacture safe and quality products consistently.
On the other hand, cGMP regulations are the updated version of GMP that considers the most updated practices and advances to comply with regulations. The FDA describes cGMPs as being more flexible in allowing different industries to apply critical control procedures in their operations. This provision is mainly achieved by allowing food businesses to use any modern and appropriate technology to achieve compliance.
Both terminologies describe minimum requirements for producing safe and quality products.
Current Good Manufacturing Practice (cGMP) regulations refer to the most updated guidelines set by the FDA to ensure safety and quality operations in the food, medical, and cosmetic industries. In particular to the food industry, the cGMP guidelines are listed under the AO 153 S.2004.
The cGMP act as the foundation of higher food safety systems. The guidelines under the cGMP lay out the requirements for hygienic conditions to reduce the risk of contamination and causing foodborne illnesses. They are based on adequate sanitation principles.
The cGMP regulations apply to all manufacturing areas, including design, development, production, testing, labeling, packaging, storage, and distribution practices. The cGMP promotes using current technology for collecting analytical records for making more informed decisions.
Compliance with the cGMP requirements is considered a prerequisite of the FSMA regulations.
In some cases, the FDA issues fines and jail time for non-compliance cases.
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.
The main goals of GMP are:
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.
In addition, GMPs ensure the consistency of product quality and reduce any safety risk without additional testing for final products.
Despite the many complex guidelines included in the GMP, food businesses are required to adhere to 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 easy steps to help every food business company to 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. All training procedures should be accompanied by appropriate training records.
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. Business owners must ensure that all manufacturing sites are built based on a plan and design elements that will minimize the likelihood 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. Food safety teams must provide guidelines for the proper handling and control procedures for both raw materials and finished products. This includes receiving, storing, processing, packaging, and the delivery of foods. The aim is to ensure that any type of contamination is reduced or at least controlled to a minimum.
Record keeping. One of the main legal requirements of GMP is for all processes to be properly recorded as proof of compliance with GMP standards. Establish a comprehensive monitoring system that will capture your operations' essential information and batch records for safety and quality-related documents.
There are many different 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 adequate food safety controls covers 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.
Below, we listed some basic operations and GMP examples that will help you secure compliance:
Compliance with the GMP regulations is a must for any food business.
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 likelihood of contamination. The section also introduces proper basic operations in maintaining the sanitized condition of a food facility. It can also include mandatory amenities needed for a food business, such as an adequate hand-washing facility and accessible toilet facilities.
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 in addressing problems as they occur.
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 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 and safety of products before release. This includes correct procedures for sampling and test methods for analysis.
Recordkeeping and Documentation. Participants will be trained on how to properly document 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 with 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.
GMP certification proves that a food business complies with the current standards under the GMP regulations. A GMP certificate is awarded by a private third-party certification body to a food business that has passed a series of inspections.
Below, we discuss in detail the following topics on the GMP certification procedure:
The GMP certification procedure aims to ensure that a food business is compliant with the basic and minimum conditions for producing safe food. 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 a document awarded to a food business for passing the GMP inspection approach that aims to ensure compliance with GMP standards. The certificate is awarded by a competent authority accredited by federal agencies.
The certificate serves as proof that the food business maintains the minimum sanitary conditions for producing safe foods. This certificate is typically valid for a maximum of 2 to 3 years and will require renewal.
Renewing a GMP certificate requires your business to undergo another round of inspection. This process aims to ensure that your food business consistently complies with food safety regulations.
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. This means that accredited bodies recognize the business to be working under the recommended sanitary conditions and quality systems for food handling and production.
In the 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.
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The GMP certification procedure requires comprehensive preparation. Your business must comply with the guidelines through your 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 systems that cover 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 food regulations.
Conduct a pre-audit. Test your team by conducting an in-house quality audit; 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 operations and present your documentation accordingly during the GMP compliance inspection.
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.
GMP audit refers to the comprehensive review that an accrediting body conducts to ensure that a food company's processes, documentation, materials, and 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 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 which 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.
The best way to prepare for GMP auditing is always to treat every operation as if you were being audited. This means that the management system must be running consistently and efficiently. All safety and quality-related documents must be accurately compiled all the time.
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. Domestic inspections cost less than international facilities.
Remember that this cost estimate is only for the audit itself. It does not include the cost of preparation for becoming GMP compliant.
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 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 on inspections based on the applicable GMP guidelines.
Learn more about developing a GMP audit checklist and get a sample checklist in the next section of this article.
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.
To help you perform your own GMP audit, we made a non-exhaustive 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 to address, which may be essential for your operations.
Consider adding points to your GMP audit checklist from our food safety tips.
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 our smart solutions, you can be ready for any inspection anytime and maintain safety and quality standards for your customers.
Our smart Food Safety Management System can provide you with the following benefits:
FoodDocs Food safety app
Receiving chilled goods log from FoodDocs
Fridge temperature log from FoodDocs
Master sanitation schedule from FoodDocs
You can also upload your own self-audit checklist and access it using our mobile app.
Production Traceability System from FoodDocs
Becoming GMP compliant requires every food manager to have a complete overview of operations. This aspect is critical for maintaining compliance and complete control of safety and quality.
We help managers improve management efficiency through the following features:
Food Safety System Set up by FoodDocs
GMP compliance focuses on proper documentation. With our smart solution, you can consistently ensure that important information is efficiently captured.
Your team can set up all of these features and more in just an average of 15 minutes. You can also further improve every monitoring log and customize them according to your operations. Quickly customize your digital documents to apply corrective actions from your inspector and quickly get ready for any reinspection.
With our smart Food Safety Management System, food businesses can intuitively stay compliant with all food safety regulations and satisfy customers with consistent quality.
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