Good Manufacturing Practices (GMP)

Good Manufacturing Practices (GMP) include basic operational conditions and processes that are required by the food business and are defined in the USA by FDA requirements outlined in 21 CFAR 110. These include the following:

Personnel Practices are documented practices for staff, including requirements for hand washing, the use of hair restraints, cleanliness of clothing, handling of staff with illness, and include documented information relating to:

• When employees must wash hands;
• What sort of hair restraints are to be worn, such as hair and beard nets;
• Cleanliness requirements for clothing, or uniforms;
• Addressing staff items such as jewelry allowed to be worn, fingernail paint and extensions;
• Employee conduct such as smoking, eating and drinking in processing areas;
• Staff hygiene training on identifying sanitation failures;
• Reporting and handling of employee illness.

Facility and grounds are practices that include management of the company’s site(s) and building(s) to prevent food safety risks, these practices specifically address:

• Maintaining of the company’s grounds in a manner that prevents potential food risks, such as standing water, dust and preventing build ups which may attract pests, this also includes managing and treating waste;
• Managing outside storage of ingredients and products in bulk containers;
• Managing the storage of equipment to prevent attracting pests;
• Providing adequate lighting and ventilation within the facility to allow adequate cleaning and prevent build up of vapors or odors.

Sanitary Operations includes maintaining of the company’s facility and equipment in a condition that prevents product from becoming adulterated, this is often accomplished by developing and documenting SSOPs (Sanitation Standard Operating Procedures), these procedures will define what is to be cleaned, how to clean the item including what utensils and equipment to clean the item with, when to clean and who is responsible for cleaning the item:

• Cleaning and sanitizing equipment including food contact surfaces and utensils within the facility, the overall cleaning plan may be maintained via the use of a Master Sanitation Schedule (MSS), which will detail what items or areas are to be cleaned and the scheduled date to clean the item or areas;
• Control of chemicals this control is often accomplished by properly identifying chemicals, and having an approval method of what chemicals are allowed as well as maintaining a documented list and inventory of the approved chemicals, these chemicals include cleaning and sanitizing chemicals, maintenance chemicals and pesticides;
• Elimination of pests via cleaning and pest control.

Sanitary facilities and controls:

• Ensuring that water used to wash hands, clean or as an ingredient in food is potable, this is typically accomplished by periodic testing of the water within the facility using ISO-17025 approved independent laboratories;
• Providing enough drains and maintaining those drains to prevent conditions of standing water within the facility;
• Providing an adequate number of toilet facilities that have hand washing that includes hot water, soap, toweling and are kept clean and well supplied;
• Providing an adequate number hand washing sinks that includes hot water, soap, toweling and are kept clean and well supplied;
• Managing waste products to prevent build ups that may cause odors or build ups that may attract pests.

Equipment and utensils include designing and maintaining the company’s equipment and utensils to prevent the potential for contamination of product:

• Managing equipment and utensil design in a manner that allows adequate cleaning and prevents contamination, this typically means that the equipment used in areas where the interaction with water is common is made from stainless steel, food contact surfaces are made from non-porous materials such as plastics;
• Seams in equipment and utensils are closed to prevent build ups of product;
• Freezers and cold storage units that are used to hold product that has a reasonable potential of growth of microorganisms be fitted with a thermometer or temperature recorder, and that the temperatures be monitored;
• Equipment that is used to record key processing parameters such as pH, water activity, etc. be accurate and properly maintained;
• Compressed or other gases (such as nitrogen used a preservative) used directly on food, on food packaging, or used to clean food contact surfaces must not be contaminated.

Processes and controls include ensuring that cleaning is performed by competent personnel, that allergen cross contact be prevented, and that ingredients and finished products be managed to prevent pathogenic growth:

• Sanitation of the facility must be controlled by competent, trained staff;
• Documented allergen controls must be in place to prevent cross contamination, the controls typically ensure that allergen containing products are identified, segregated, and cleaning is managed in a way to ensure that any traces allergens are removed when allergens differ from run to run;
• Testing be performed to ensure that identify sanitation and other cleaning failures be identified and remedied, this is typically performed by trained staff as part of the documented preoperational inspection;
• Potentially contaminated food be managed in a way that prevents unintended use, this is typically managed via the use of a documented nonconformity process;
• Performing a documented inspection of incoming ingredients to ensure that the items are pose no food safety threat, if the ingredients can potentially contain pathogenic microorganisms that they be treated with a kill step, such as pasteurization, and be stored at suitable temperatures;
• Equipment and utensils used to process food items be cleaned and sanitized, as needed;
• Work in-process and finished goods must be maintained in a manner to prevent cross contamination with unprocessed items and dissimilar allergens;
• Foreign materials such as wood or metal be prevented, metal is typically prevented via the use of screens, sieves and metal detectors;
• Food and raw materials must be disposed of in a manner that prevents possible contamination of product.

Warehousing and distribution include storing and transporting products under conditions that prevents growth of pathogens, prevents contamination chemical and foreign material contamination:

• Foods and their containers must be handled in a manner that prevents the deterioration or contamination of the product and container while in storage or while being transported, this can included verification that trucks and storage areas are free of pests, potential contaminants such as toxic chemical, and in the case where the item is subject to pathogenic growth, storing and transporting in frozen or refrigerated conditions.

Human food by-products held for distribution as animal food without additional manufacturing or processing by the human food processor includes managing the product to prevent contaminants, adequate labeling and managing of storage equipment:

• Equipment used to move and store human food by-products must be adequately designed and maintained, including cleaned in a manner that prevents contamination, including contamination with trash or other non-food waste, the containers are to be inspected prior to use;
• Human food by-products used for animal food must be adequately identified when in storage or transit.

Human food by-products held for distribution as animal food without additional manufacturing or processing by the human food processor includes managing the product to prevent contaminants, adequate labeling and managing of storage equipment:

• Equipment used to move and store human food by-products must be adequately designed and maintained, including cleaned in a manner that prevents contamination, including contamination with trash or other non-food waste, the containers are to be inspected prior to use.