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Facility Requirements

These requirements are a part of the Current Good Manufacturing Practices that relates to Facility Requirements. You can see the full guide to cGMPs here

Plants & Grounds

Grounds must be kept in a condition that protects against contamination. Methods include:

1. Eliminate conditions for breeding/harboring pests
2. Maintain roads, yards, parking lots
3. Drain areas (i.e. puddles) that may breed pests or contribute to food contamination
4. Even if the grounds aren’t in your control, you must still mitigate contamination hazards.


Plant Construction and Design

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The space must be suitable in size, construction and design for food production.

1. Must have adequate space for equipment and storage.

2. Must allow you to take precautions which reduce allergen contamination and food contamination (for example -- by chemicals, filth, other materials). Ways to eliminate contamination include separating operations by: location, time, partition, air flow systems, dust control system, etc.

3. Protect food that is stored outside in bulk containers:

4. Floors, Walls, Ceilings must be constructed in a way that allows them to be cleaned. The construction of the space must allow employees to do their jobs and not contaminate food, packaging, and work areas.

5. There should be adequate lighting in all food and employee areas (including food storage areas and employee locker rooms). All bulbs and glass that is suspended over areas where food is exposed should be shatter resistant.

6. There should be adequate ventilation to minimize dust, steam, odors, and vapors.

7. Provide screens or other protection against pests (door sweeps, air curtains)


Sanitary Facilities

Plumbing

Water Supply must be from an adequate source. Running water must be of a suitable temperature and pressure and be provided in all food processing/cleaning areas.

Plumbing must

1. Carry adequate amounts of water around the plant.
2. Remove sewage from the plant.
3. Avoid contaminating food, equipment, water supply, utensils, ec.
4. Provide floor drainage in spaces where floors get very wet
5. Avoid back flow between plumbing systems

Sewage Disposal: Sewage must be disposed of adequately

Toilet Facilities: Each plant must have clean toilet facilities.

Hand-washing facilities: Each plant must provide hand washing facilities.

Rubbish: store rubbish to minimize odor, pests, and contamination


Exemptions

This section applies to most traditional food processors that fall under FDA jurisdiction. However, there are some notable exceptions.

  • Farms

  • Fishing Vessels

  • Establishments who solely hold and transport agricultural products

  • Establishments who only raw process (i.e. shell or dry) nuts.

  • Mixed-Type farm facilities (defined in §1.227)


 
 

This Article is For You if…

∆ You are seeking to understand facility requirements for your FDA-regulated food business.

∆ You manage a facility that makes, holds, or packs food.


More About Operating Requirements

More Posts


References

Guide to Current Good Manufacturing Practices (117 Subpart B)

Guide to Current Good Manufacturing Practices (117 Subpart B)

Personnel Requirements in Food Processing Spaces

These requirements are a part of the Current Good Manufacturing Practices. You can see the full guide to cGMPs here

Personnel Requirements

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Employees working in food processing spaces are subject to basic requirements about disease control and cleanliness. The aim of these requirements is to make sure a food processor does contaminate their own food product which could cause a customer to become sick.

Disease Control:

Sick employees must be excluded from operations that could result in food contamination.

The typical way of doing this implementing an Employee Hygiene Policy that excuses sick employees from work. This may require food production employees who have been exposed to a serious contagious illness to refrain from working until they are no longer contagious.

Cleanliness:

This section states that employees must have clean practices

1. Clothing that protects against contamination
2. Adequate personal cleanliness
3. Hand washing
4. Removing unsecured jewelry
5. Wearing gloves in a safe manner
6. Wearing hair restraints
7. Storing other belongings in areas where food is exposed/equipment is washed.
8. Not eating food, chewing gum, drinking beverages, or using tobacco in food areas.
9. Taking other precautions


Exemptions

This section applies to most traditional food processors that fall under FDA jurisdiction. However, there are some notable exceptions.

  • Farms

  • Fishing Vessels

  • Establishments who solely hold and transport agricultural products

  • Establishments who only raw process (i.e. shell or dry) nuts.

  • Mixed-Type farm facilities (defined in §1.227)


 
 

This Article is For You if…

∆ Your business is regulated by the FDA

∆ You have employees who work in a space where food is handled, packed, or produced.


More About Operating Requirements

More Posts


References

Guide to Current Good Manufacturing Practices (117 Subpart B)

Guide to Current Good Manufacturing Practices (117 Subpart B)

Equipment and Utensils

These requirements are a part of the Current Good Manufacturing Practices that relates to Equipment and Utensils You can see the full guide to cGMPs here

Equipment Requirements

  • Equipment and utensils must be designed to be cleanable and maintained to avoid contamination.

  • Equipment and utensils must not contaminate food with lubricants, metal fragments, water, etc.

  • Equipment must be installed in a way that they can be cleaned and maintained.

  • Equipment kept in food areas must be constructed so it can be kept clean -- even if it doesn’t contact food.

  • Machinery must be designed in a way that can be kept clean

  • Each freezer and refrigerator must have a thermometer in it.

  • pH meters, thermometers, and other measuring devices must be accurate.

  • Compressed air must be treated in a way that it does not contaminate food.


Food Contact Surface Requirements

  • Food-contact surfaces must be corrosion-resistant.

  • Food-contact surfaces must be non-toxic

  • Food-contact surfaces must be maintained to protect food from allergen cross-contact

  • Seams on food-contact surfaces must be seamless to minimize accumulation of particles.


References

Guide to Current Good Manufacturing Practices (117 Subpart B)

Guide to Current Good Manufacturing Practices (117 Subpart B)

 
 

This Article is For You if…

∆ Your business is regulated by the FDA

∆ You manage a facility that makes, holds, or packs food.

∆ You use equipment and utensils in your operation


More About Operating Requirements

More Posts