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App for Good Manufacturing Practices (GMP) for food handlers

Maximize your teams adherence to Good Manufacturing Practices GMP in your food manufacturing, processing, and food handling business. The app helps guide employees through food manufacturing tasks one at a time ensuring manufacturing tasks are performed at the correct time using correct materials and equipment. The app also ensures quality control tests are performed on food products at every critical control point required during the food manufacturing process.

Good manufacturing practices (GMP) in the food manufacturing industry:

Good manufacturing practices food app
Good manufacturing practices food app

Consumers put a great deal of trust in the manufacturers who make the products they use daily, like medicines, car parts, cosmetics, and food. When products have to be recalled, this can cast doubt in the minds of consumers, which is why prevention is so important. Here's what you need to know.

Manufacturers need to do everything they can to foster the trust they are given, and take the necessary steps to keep it. One way to do that is by implementing Good Manufacturing Practices (GMP).

What are Good Manufacturing Practices for food processors, manufacturers, and handlers?

Good Manufacturing Practices (GMP) is a system that ensures that the goods produced by various manufacturing facilities are consistently produced and controlled according to specified quality standards. There are GMP systems for everything from cosmetics to pharmaceutical products to, of course, food.

GMP looks at every aspect of the manufacturing process to guard against potential risks that can prove detrimental to the products being produced. Cross-contamination, mislabeling, and adulteration are just a few of the things GMP aims to prevent.

The FDA regulates the Current Good Manufacturing Practices (CGMP), and therefore requires companies to abide by their specified guidelines. They are considered "Current" because, as new information is discovered, the Good Manufacturing Practices released by the government will change to reflect the new finding(s).

These Practices are made to be flexible, to better allow companies to adjust them to fit their specific needs. However, to meet the GMP and CGMP guidelines, certain areas still have to be met accordingly.

Why Good Manufacturing Practices (GMP) are so important when handling food:

Good Manufacturing Practices are a critical system that all manufacturing facilities should implement. They help ensure the proper design, monitoring, and control of the manufacturing processes and facilities. Companies that adhere to these standards help to assure the identity, strength, and quality of their products. When implemented, GMP can help to cut down on facility losses and waste and also help to protect the company, consumer, and the environment from harm.

The Current Good Manufacturing Practices are set by the FDA and give manufacturers across all industries a set of standards to strive for. They help facilities earn and maintain the trust of consumers who want to know the products they buy are manufactured in safe, well-regulated environments, and to government standards.

Good Manufacturing Practices in food industry manufacturers are especially vital these days, due to the increasing number of food recalls occurring. Consumers have become increasingly aware of food safety and expect companies to take steps to increase their accountability, and provide them with safe products that will not get recalled.

How to become Good Manufacturing Practice (GMP) compliant food handler using theProducepak GMP app:

There are a number of things in the GMP of food industries and manufacturing industries in general. In some cases, if the FDA's guidelines aren't met, it can result in severe legal penalties.

1. QUALITY MANAGEMENT

Quality management is a principle that focuses on ensuring that manufactured products are fit for their intended use. For food, this means ensuring that the food meets the FDA's food safety and quality measures. So, there should be no raw, expired, or improperly processed products that can potentially harm consumers or cause contamination.

2. SANITATION AND HYGIENE
Good manufacturing practices food app
Good manufacturing practices food app

In terms of Good Manufacturing Practices, there is nothing more vital than sanitation and hygiene, particularly for drug, cosmetic, and food manufacturers. This covers anything that can lead to contamination, if proper hygiene and sanitation is not practiced. One step a facility can take to ensure proper sanitation and hygiene is to install a food-grade stainless Slot Drain drainage system. Slot Drain is a grate-free in- loor drain that is resistant to things like extreme temperatures, corrosion, and bacteria. It comes pre-sloped and pre-assembled, making it easy to install and maintain, and it is an ideal addition to manufacturing facilities.

3. SUITABLE FACILITY LOCATIONS

The FDA's Current Good Manufacturing Practices state that manufacturing facilities should be in a suitable location, free from the risk of any contamination. Additionally, the facility should be designed to help minimize the risk of potential errors in operations and should be easy to clean and maintain.

4. EQUIPMENT

Similar to the location requirements, any equipment within the facility should be designed, located, and maintained to function as intended. All equipment should also be regularly cleaned and stored according to the proper procedures, and removed if found defective or malfunctioning.

5. RAW MATERIALS

Any materials for production are required to be stored appropriately. Furthermore, a proper inventory of the raw materials the facility has in stock should be available and updated regularly, as well as documentation of where the materials come from, to ensure quality.

6. PERSONNEL
Good manufacturing practices food app
Good manufacturing practices food app

Naturally, successful GMP compliance relies heavily on facility personnel. Everyone who works for the facility should be well-trained and qualified to do their assigned job. They should have a clear awareness of the various GMP principles and receive continual training, so they are always up-to-date with their job skills and what is expected by the FDA.

7. VALIDATION AND QUALIFICATION

The critical steps of the manufacturing process should be validated to ensure they meet specific GMP qualification guidelines. Regular reviews of this process will also help to ensure that product quality remains high and consistent.

8. HANDLE COMPLAINTS

Another key factor of Good Manufacturing Practices includes handling complaints. All companies and facilities should have a GMP-compliant system for handling complaints. The ideal complaint system should include prepared solutions for all contingencies within the facility.

9. DOCUMENTATION AND RECORDKEEPING

Keeping thorough records is an essential part of any company, and therefore a critical part of the GMP. Everything about the facility should be documented in clear, legible ways. All documents should be kept in an organized system where managers can easily find and refer to various aspects of the facility at any time.

10. INSPECTIONS AND QUALITY AUDITS

Another step that goes into Good Manufacturing Practices in all facilities are inspections and quality audits. By regularly conducting inspections and audits, facilities can ensure that they are properly complying with the GMP. These checks will also help to keep the facility from forgetting to follow the guidelines; otherwise, they will be hit with serious consequences.

Comply with Good Manufacturing Practices (GMP) requirements: 

Now you know about Good Manufacturing Practices and why they are essential. Regardless of the type of manufacturing facility, GMP is a critical part of running a high-quality facility. By being GMP compliant, facilities make a strong effort to create a safe, high-quality, and sanitary environment to create safe and high-quality products for consumers. They are standards to strive for, particularly for facilities producing products that people consume, like pharmaceuticals and, of course, food.  GET PRODUCT GUIDE


Development of Food Good Manufacturing Practices (GMPs)

Food safety has been regulated since the mid-1800s and was mostly the responsibility of local and state regulators. However, the Pure Food and Drugs Act, passed by Congress in 1906, marked the first major federal consumer protection law with respect to food processing. The 1906 law prevented interstate and foreign commerce in misbranded or adulterated foods, drinks, or drugs. The intent of the Act was to prevent poisoning and consumer fraud. As more food products were manufactured in subsequent years, however, poor-quality food products and deceptive packaging continued to be produced due to loopholes in the law. Consumers were often unaware of what they were buying until products were opened. Therefore, in 1933, the FDA decided to overhaul the 1906 Act.

In 1938, after a battle about USDA jurisdictions with respect to the Act's enforcement, the Food Drug, and Cosmetic Act (FDCA) replaced the 1906 Act. The FDCA provided the necessary identity and quality standards to protect consumers from fraud. The FDCA provides the regulatory basis for today's food GMPs. Two sections of the FDCA are directly related to conditions in a facility where food has been manufactured.

  • Section 402 (a)(3) specifies that food has been manufactured under such conditions that it is unfit for consumption.
  • Section 402 (a)(4) considers that food may be adulterated if it is prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health.

These provisions are unlike other parts of Section 402, in that they relate to the conditions of a facility where food is produced or stored. Thus, instead of having to prove that the food is adulterated, insanitary conditions are considered sufficient to show that the food might have become adulterated.

Given the FDCA's vagueness in establishing violations and thus, the difficulty of enforcing it, FDA began working on draft GMP regulations by the mid-1960s (although others had made the suggestion to do so as early as 1948). The objective of the GMP regulations was to describe general rules for maintaining sanitary conditions that must be followed by all food processing facilities to ensure that the statutory requirements of Section 402(a)(3) and (4) were met. After much industry involvement, including much debate about FDA's authority to adopt rules to carry out the provisions of the FDCA, the GMP regulations for food processing facilities were finally proposed in 1968 (see Table 1-1).

Three broad categories of interrelated issues arose during the development of the GMPs (Dunkelberger, 1995):

  • Concern that the regulations were unduly stringent and especially burdensome for small food companies without necessarily improving the quality or safety of foods.
  • Contention that the GMP regulations must prescribe conditions that "reasonably" relate to insanitary conditions that may contaminate food and render it injurious to health.
  • Assertions that the regulations did not have the force of law.

These first two issues were resolved mostly through the use of more general terms, such as "adequate," "sufficient," and "suitable," rather than hard-line standards. FDA also used "shall" when the agency felt compliance was necessary and "should" when practices in the rule were less obviously related to the statutory requirements of the Act. The third issue became inconsequential when it was proved that FDA did have the statutory authority to promulgate the GMP regulations. The GMP regulations were finalized in April of 1969 and published as Part 128 of the Code of Federal Regulations (CFR). In 1977, Part 128 was recodified and published as Part 110 of the CFR.

The final GMP regulations were very broad, not specifying what exactly a facility must do to comply. This naturally created enforcement problems for the FDA. To address the ambiguity created by the umbrella GMPs, FDA next tried to develop industry-specific GMPs through the mid-1970s. By the late 1970s, however, FDA decided to improve the umbrella GMPs rather than adopting industry-specific GMPs. The revisions were finalized in 1986 and printed in 21 CFR 110. Specific GMPs were also included and printed in 21 CFR Parts 100 through 169 for:

  • Quality control procedures for nutrient content of infant formula (21 CFR 106).
  • Thermally processed low-acid canned foods in hermetically sealed containers (21 CFR 113).
  • Acidified foods (21 CFR 114).
  • Bottled drinking water (21 CFR 129).

In July of 2002, FDA formed a Food GMP Modernization Working Group to examine the effectiveness of current food GMPs given the many changes that have occurred in the food industry since 1986. The Working Group has been researching the impact of food GMPs on food safety, as well as on the impact (including economic consequences) of revised regulations. Part of the group's current effort, as of June 2004, is to find out which elements of the food GMPs are critical to retain and which should be improved. FDA is now holding public meetings to obtain the public comments to assist in this effort.

Key Provisions of Food GMPs

The current GMPs consist of seven subparts, two of which are reserved. The requirements are purposely general to allow individual variation by manufacturers to implement the requirements in a manner that best suit their needs. Table 1-2 summarizes the five written subparts, which are discussed in further detail below.

General GMP Provisions

The general provisions in Subpart A of the food GMPs are divided into four sections. The first section defines much of the terminology used in describing GMPs. The terms "shall" and "should" are also defined to differentiate between when compliance is necessary ("shall") and when procedures and practices are not directly related to insanitary conditions as specified in Section 402(4)(a) ("should").

The section on personnel delineates plant and employee responsibilities with regard to personal hygiene. For example, personnel with diseases or other conditions that could contaminate food are to be excluded from manufacturing operations. The section also outlines expectations with respect to personal hygiene and cleanliness, clothing, removal of jewelry and other unsecured objects, glove maintenance, use of hair restraints, appropriate storage of personal items, and restrictions on various activities, such as eating and smoking. The section discusses the need for appropriate food safety education and training in very general terms. The subpart further mandates the assignment of supervisory personnel to ensure compliance.

Currently, establishments that only harvest, store, or distribute raw agricultural commodities are exempt from the requirements of Subpart A, although FDA reserves the right to issue special regulations to address this sector.

Buildings and Facilities (GMP)

Subpart B of the food GMPs outlines requirements for the maintenance, layout, and operations of food processing facilities.

Section 110.20 outlines the requirements for adequate maintenance of the grounds, including litter control, waste removal and treatment, and grounds maintenance and drainage. The subpart requires that plants be designed and built to reduce the potential for contamination. Some detail is provided on how to achieve this, but the requirements are largely focused on the end result of a sanitary facility rather than specific practices. The language also includes many general terms to allow flexible implementation of the requirements.

Section 110.35 describes sanitary operations. Physical facilities, equipment, and utensils are to be sanitized in a way that protects against food contamination. Storage of cleaning materials and toxic materials permitted are outlined to prevent contamination with chemicals. The section also briefly addresses pest control and cleaning of various food contact surfaces, as well as the frequency of cleaning.

Section 110.37 describes the requirements for adequate sanitary facilities and controls, including the water supply, plumbing, toilet and hand-washing facilities, and rubbish and offal disposal.

Some of the requirements of the section are fairly specific, such as the requirement of self-closing doors for toilet facilities, whereas others remain general, such as plumbing of adequate size and design.

Equipment  

Subpart C describes the requirements and expectations for the design, construction, and maintenance of equipment and utensils so as to ensure sanitary conditions. It also adds a specific requirement; an automatic control for regulating temperature or an alarm system to alert employees to a significant change in temperature. Other requirements of the subpart are fairly general and intended to prevent contamination from any source.

Production and Process Controls in Good Manufacturing Practices (GMPs)

The first section of Subpart E lists the general sanitation processes and controls necessary to ensure that food is suitable for human consumption. It uses more general words (e.g., "adequate," "reasonable," etc.) and covers many aspects not discussed in previous subparts. This section also addresses the monitoring of physical factors (critical control points), such as time, temperature, humidity, pH, flow rate, and acidification.

The second section outlines very general requirements for warehousing and distribution. The section requires finished foods to be stored and distributed under conditions that protect against physical, chemical, and microbial contamination. The container and the food must also be protected from deterioration.

Defect Action Levels (DALs in GMP)

The last subpart of the food GMPs allows FDA to define maximum defect action levels (DALs) for a defect that is natural or unavoidable even when foods are produced under GMPs as set out in the other subparts of the regulations. Generally, these defects are not hazardous to health at low levels; they include rodent filth, insects, or mold. The DALs are defined for individual commodities and may be obtained by request from FDA, which produces a Handbook on Defect Action Levels for Food. They are also available from the FDA Web site Defect Action Levels handbook. Table 1-3 provides examples of the maximum DALs for select food products. Manufacturers are expected to use quality control operations that reduce the level of the defect to the lowest possible levels. Those exceeding maximum DALs will be considered in violation of Section 402 (3)(a) of the FDCA.

The section bans blending of food with a defect level above a maximum DAL with other food. It also stresses that compliance with DALs does not excuse violations of Section 402(4)(a) of the FDCA or that of the other subparts of 21 CFR 110. Find more GMP info at FDA.gov.

The food processing industry has the prime responsibility for food safety by ensuring the materials and products supplied to them, as well as their produces and processes,  are safe for the consumer.

As well as ensuring food products are made in safe environments, food processors also have to be able to prove to relevant authorities that their employees, machinery and facilities comply with legislation and regulation requirements.

This has to start with commitment from top management, as required in ISO 22000, with a ‘fundamental statement of intent’:

  • putting food safety as a business objective;
  • communicating to staff the requirement for food safety;
  • establishing a food safety policy, signed by the person with overall responsibility;
  • conducting regular reviews of safety;
  • allocating sufficient resources.

The Good Manufacturing Practice (GMP) principles of a food safety program

Ensuring strong compliance with food safety standards involves achieving a series of ‘prerequisites’ to adhere to. The requirements below are based on the Codex Alimentarius and GFSI recommendations, which are followed by regulating and standards bodies worldwide.

Facilities

An important GMP for food processing facilities is the location, design and construction of the facility. This gives a basic foundation for controlling external risks to food safety and improves the ability to maintain hygiene, store materials safely, and remove waste effectively.

  • Location: The facility should be located to reduce the risk from pollution, flooding, pest infestations and waste accumulation.
  • Design and construction: The design and layout should enable maintenance, cleaning and hygiene practices. It must also prevent physical, chemical and biological contamination. Durable materials must be used which are suitable for use in food preparation and storage areas as well as adequate drainage systems in place.
  • Equipment and containers: Equipment, working surfaces and reusable containers coming into contact with food should be made of food-safe material and designed with cleaning and disinfection in mind to ensure food safety.
  • Food hygiene: Suitable facilities should be in place to hygienically clean food, utensils and equipment with an adequate supply of potable water.
  • Personnel hygiene: Staff should be provided with adequate facilities to maintain personal hygiene. Said facilities must provide the appropriate tools to ensure hand hygiene is met to a high standard as well as suitable washroom and changing facilities.
  • Air ventilation: To control aerosols, condensation, temperatures, odours humidity and dust a food processing facility must have the correct ventilation and air conditioning systems in place. These mist also be able to prevent contamination and be easily cleaned and maintained.
  • Water supplies: The facility should have adequate supplies of water for food processing, cleaning and fire control. Non-potable water should have a separate system that prevents contamination.

Cleaning and hygiene

GMP for food processing state that the business should establish effective procedures and methods to prevent contamination of food through systems for cleaning of food production areas and equipment, pest control and waste management.

  • Cleaning of facilities: Building exteriors, interiors, food production areas and equipment should be maintained and cleaned on a regular basis to prevent contamination. Cleaning and disinfection products must be used according to manufacturers’ instructions and stored safely.

  • Pest control: The monitoring, prevention and control of pests must be installed to prevent contamination. Inspections of incoming materials and products for pests need to be in place as well as providing documentation of pest control activities as required by legislation.

  • Waste management: An essential part of preventing contamination. Effective and legally compliant procedures and facilities need to be established to effectively manage waste produced in food processing facilities as well as being pest resistant.

Personnel hygiene and health

The personal hygiene and health of staff are an important GMP in food processing. Effective procedures need to be in place to help ensure staff follow the appropriate hygiene practices in manufacturing facilities in order to help ensure food safety has adhered to a high standard.

  • Health status: People known to be suffering from or carrying an infectious disease, or suspected to be, must not be allowed to enter a food processing area.
  • Injuries: Cuts and skin abrasions should be covered with suitable dressings
  • Personal hygiene: Hand hygiene must be adhered to a high standard especially before entering food handling areas and also at appropriate times such as before and after eating.
  • Hygienic clothing: Items such as gloves, hair coverings and footwear must be worn by handlers in order to protect food from contamination. Additionally, said clothing must be made or appropriate materials and cleaned regularly.

Transportation

Transportation affects food products before and after the manufacturing process. Therefore GMPs should be implemented to ensure raw materials, ingredients, packaging, semi-processed and finished products are transported in conditions that protect them from contamination, damage and spoilage.

  • Vehicles, containers and packaging: Must be suitable for the products and conditions of transport, to maintain the integrity of the products and prevent pests and human interference.
  • The temperature, humidity, atmosphere and other conditions: Should be maintained at suitable levels to prevent spoilage, deterioration; and these are also recorded;
  • Vehicles and containers: Do not contaminate the product from materials used in their construction, dust and fumes. Additionally, they should be maintained in a good state of repair and cleanliness.
  • Regular inspection: Vehicles, containers, packaging and products are inspected before loading and on arrival at the food processing facility eg for contamination, pests, transport conditions.
  • Loading and unloading areas: Must be of appropriate construction and design to protect the transported product during loading/ unloading. Said areas must also kept clean and spills removed quickly.
food safety for food processing good manufacturing practices
food safety for food processing good manufacturing practices

Extrusion Cooking for Fortified Blended Foods (FBFs)

Extrusion is the process of forcing a material through a specifically designed opening. Material is continuously metered into an inlet hopper and then transported forward by the rotating screw. as the material approaches the die, there usually is an increase in pressure and temperature.

Mechanical disruption of the cell walls and starch of plant products occurs during extrusion cooking, facilitating digestion, and absorption. This mechanical breakdown of starches reduces the viscosity of gruels made from extruded cereals to enhance their caloric and nutrient density. The high-temperature heat treatment effectively pasteurizes the product. A good packaging is required to provide resistance to moisture and insects.

Extrusion cooking is the recommended method for manufacturing Fortified Blended Foods.

Dry extrusion is preferred for the production of Super Cereals. This type of extrusion does not require an external source of heat or steam. All the cooking is accomplished by friction capitalizing on the inherent moisture and/or oil for providing lubrication. The dry extruder can process material bearing 8-22% moisture without the need for drying the extrudate.

Wet extrusion is considered more appropriate for the manufacturing of Super Cereals plus.

The advantages of extrusion are summarised in the scheme next.

Other processing technique which can be applied for the thermal treatment of the raw materials is:

The validation of drum drying  is necessary to the extent of ensuring that WFP requirements for product stability, product self-life, energy density and acceptability are met.

Food Fortification & Coefficient of Variation (CV) Calculation

Why fortification?

Fortification is one of the least costly and most efficient means of combating micronutrient deficiencies.

Addressing micronutrient deficiencies globally will require an estimated $1 billion per-year about $1 per affected person (all dollar amounts are U.S. dollars). That figure is equivalent to the economic costs of endemic deficiencies of vitamin A, iodine, and iron in a single country of 50 million people. Most of these costs will ultimately be borne by consumers when purchasing food with higher nutritional quality. (Enriching Lives: Overcoming Vitamin and Mineral Malnutrition in Developing Counties, World Bank, 1994)

WFP is committed in providing appropriately fortified food commodities in order to increase the intake of micronutrients, thereby improving micronutrient status and preventing damage caused by deficiencies.

Foods may be fortified with single nutrients (salt with iodine, vegetable oil with vitamin A) or with several vitamins and minerals (e.g. fortified cereal flour, super cereals).

See more at WFP's Food and Nutrition Handbook.

Steps for Food Fortification

1. Determine the appropriate technique and type of premix / fortificant

These depend on the technology available but most importantly on the food vehicle. E.g. for powdered products batch mixing or continuous metering can be used for the addition of a selected premix.

2. Procure the premix from a WFP-approved premix supplier

Quantitative analyses should be carried out for each micronutrient in each batch of any bulk vitamin or mineral premixes manufactured. A Certificate of Analysis (CoA) must be delivered along with the premix by the premix supplier.

3. Store the premix properly

Vitamins and minerals premixes should be stored in a dry, clean and cool place. These products should be locked when not used, as accidental ingestion is a health hazard.

4. Add the premix and monitor the procedure

Keep a permanent record of calculations for vitamin/mineral additions to the finished product to demonstrate whether additions theoretically give the correct range.

Verify proper premix addition by calculating the Coefficient of Variation. The CV demonstrates whether the mineral and vitamins premix is homogeneously distributed in the finished product.

Regular testing and recording of the in-line accuracy of the metering pump (calibration).

Make a visual check every 1-2 hours to make certain that the vitamin preparation is being used up at a consistent rate and keep records of this (e.g. iron spot check).

Keep daily records (inventory) showing actual vitamin usage and actual flour production.

Perform finished product quality controls. Each lot should be sampled and tested for compliance with its chemical and physical specifications prior to release by the QA/QC department. Testing for each lot should include analysis for part or all added vitamins and minerals.

NOTE: Processing conditions and critical stages of the manufacturing process should be monitored in such a way as to ensure that no unexpected nutrient losses ocurr during processing or after unpredictable delays. Monitor recording charts of time/temperature history during thermal processing or during drying.

Coefficient of Variation (CV) Calculator

The evaluation of mixer efficiency requires that a minimum of 10 samples of about 100g be taken at equal intervals as the batch passes an access point immediately after discharge from the mixer. Samples must be sent to the laboratory for evaluating one or two key components. Usually those that are easy to assay and are of low concentration in the product, and thus more difficult to distribute evenly throughout the product (e.g. minerals, such as iron or zinc).

  • For continuous mixing: for example to take a sample every 15 seconds to obtain a profile.
  • For batch mixing: for example a 250 kg capacity mixer, to take a sample in each of the 25 kg bag to obtain a profile.

Click on the picture to start the calculation.


Result evaluation

A profile may be considered to be satisfactorily homogeneous if the coefficient of variation is no larger than 10% (i.e. +/- 10% around the average).

If CV greater than +/- 10% mixing time should be increased, if it is not sufficient to reduce the CV, then two-step mixing (i.e. use of preblend) should be envisaged.

GMP in the Food industry

February 16, 2012 / 75 Comments

What is GMP?

GMP is short for good manufacturing practices and forms an important part of the overall HACCP food safety system in a food business. Good manufacturing practices (GMP) can be defined as the operational requirements necessary to enable a food business to produce food safely. There is a heavy emphasis on compliance with Good manufacturing practices (GMP) in all relevant food legislation and customer certification standards.

Why is GMP important?

Good manufacturing practices (GMP) are important in order to produce safe food. The food business has a legal and moral responsibility to produce and prepare food that will not harm the consumer. There can be a high cost to the food business if it does not implement adequate Good manufacturing practices (GMP). All staff should be trained in the food businesses GMP procedures.

Basic GMP and the food business

Good manufacturing practices (GMP) includes many basic operational conditions and procedures that are required to be met by the food business. These can include the following:

  • The correct construction and layout of the food premises.
  • The condition of the external environment of the food premises.
  • The adequate maintenance of equipment and utensils used within the food business.
  • The use of suitable chemicals within and around the food premises including cleaning chemicals, pest control chemicals and machine lubricants.
  • The identification and storage of waste within and by the food business.
  • The cleanliness of the food premises, equipment, utensils, floors, walls and ceilings.
  • An effective pest control program implemented within the food premises and surrounds.
  • The avoidance of foreign matter within the finished product. Sources of foreign matter can include wood, glass, metal, plastic, pests, paper, string, tape.

Documenting GMP

HACCP Good Manufacturing Practices

Personnel


Meat processing companies will need written guidelines and programs for the personnel that work in the food production facilities. GMP's for personnel should cover disease control, cleanliness, education and training, and supervision. All employees that work in the food production areas of the plant should be aware of the plant GMP's for personnel. This may be accomplished by providing information during the interview process of hiring of employees, by an intensive training session after hiring a new employee (Figure 2) and by educational updates on a yearly or as needed basis.

Meat processing companies will need written guidelines and programs for the personnel that work in the food production facilities. GMP's for personnel should cover disease control, cleanliness, education and training, and supervision. All employees that work in the food production areas of the plant should be aware of the plant GMP's for personnel. This may be accomplished by providing information during the interview process of hiring of employees, by an intensive training session after hiring a new employee (Figure 2) and by educational updates on a yearly or as needed basis.

Education and Training for Employees

Disease control is an important aspect of food safety. Any person that is ill should not be working with food production. Some processing plants have standard a policy requiring employees to get a doctors approval to return to work if they miss two or more work days due to sick leave. Addition production employees should not have open lesions, included boils, sores or infected wounds. Both illnesses and open lesions could be a source of microbial contamination for the food or the food-contact surfaces.

Personnel in the production area will also need to practice many things related to cleanliness (Figure 3). This would include outer garments, personal cleanliness, washing hands, removing jewelry, maintaining gloves, wearing hairnets, storing of personal belongings, and excluding such things a gum, tobacco and makeup from the food production area.

Practice Proper Personnel Cleanliness

Many meat processing companies in the United States provide production employees with proper clean outer garments. In some facilities outer garments are color coded to ensure that employees from the uncooked segment of production are clearly identified from employees in the cooked segment of the facility. Removing jewelry that might fall into food products and result in a physical hazard or microbial contamination.

Production and Process Control

This subpart describes the most detailed requirements. It includes a large section on processes and controls and a small section on warehousing and distribution.

The section on processes and controls has two major subdivisions: (a) raw materials and other ingredients; and (b) manufacturing operations. The first subsection has descriptions of required inspection, storage and handling of ingredients. Specific information regarding the treatment of ingredients subject to microbiological activity and the handling of ingredients subject to aflatoxin or other toxins is provided. Requirements on storage of frozen raw materials and ingredients, and bulk liquid and dry ingredients are also given. The manufacturing operations subsection requires conditions and controls necessary to minimize the potential for growth of microorganisms, or for the contamination of food. Monitoring of factors such as time, temperature, humidity, water activity, pH, pressure and flow rates is important for the control of conditions. The following requirements for holding foods are given in this subsection:

(a) Refrigerated foods must be kept at or under 45' F (7.2 0 C) as appropriate for the particular food involved.
(b) Frozen foods must be maintained in a frozen state.
(c) Hot foods must be kept at or above 140o F (60o C).

The manufacturing operations subsection also requires the establishment of measures that prevent the finished food product from contamination by raw materials, other ingredients, refuse and metal or other foreign materials.

The section on warehousing and distribution requires that the transportation and storage operations are conducted under conditions that prevent physical, chemical and microbiological contamination.

Buildings and Facilities

The general principles of plant design and construction is necessary to assure sanitary conditions are given in the plant and grounds section of this subpart. Adequate lighting and ventilation are required under this subpart.

The sanitary operations section establishes general maintenance requirements and provides specific requirements regarding the storage and use of cleaning and sanitizing agents and other toxic substances (Figure 4). Pest control and the storage and handling of cleaned equipment and utensils are also addressed.

Figure 4. Proper Storage of Chemicals in a Food Production Facility

In the sanitary facilities and controls section minimum requirements are established for: water supply, plumbing, sewage disposal, toilet facilities, hand-washing facilities and rubbish and offal disposal.

Good manufacturing process
Good manufacturing practices app

Equipment

In this subpart the general principles of design, construction and maintenance of equipment and utensils are described. Protection against contamination of food with lubricants, fuel, metal fragments, contaminated water and other contaminants must be provided. Easiness of cleaning and maintenance of clean conditions are emphasized.

Instrumentation used to control critical parameters like pH, temperature and water activity must be accurate and adequately maintained.

Defect Action Levels

The last subpart of 21 CFR I 10 covers natural or unavoidable defects in food for human use that present no health hazard. The FDA recognizes that defects can be present in foods produced under current good manufacturing practices (GMPs). The FDA has established maximum levels for these defects and uses them in deciding whether to recommend regulatory action. These FDA guidelines cannot be used as an excuse for not following the GMPs. Defect action levels are not listed in the CFR; however, subsection (e) in section 110. 110 provides information on how to obtain a current list.

Good manufacturing practices app coffee
Good manufacturing practices coffee

To assist in the effective implementation of Good manufacturing practices (GMP) within the food business it is advisable to document procedures on how the food business is going to implement relevant Good manufacturing practices (GMP). Equally important is to maintain records to support that any Good manufacturing practices (GMP) have been implemented.

The GMP Inspection

To ensure the effective implementation of Good manufacturing practices (GMP), it is beneficial for the food business to undertake its own internal GMP inspection. This generally involves reviewing the site visually to see if it is complying to customer expectations and regulatory requirements. This inspection should not merely be a “tick and flick” activity but a comprehensive assessment of the site to determine the level of GMP compliance. A record of any GMP inspection undertaken is required to be kept as evidence in a third-party certification audit. Any issues identified during the GMP inspection should be quickly rectified and a root cause analysis performed to avoid reoccurrence.

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Good Manufacturing Practices for food (GMP Food)