1 GOOD MANUFACTURING PRACTICES 2214 Steven C Seideman Extension Food Processing Specialist...

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GOOD MANUFACTURING GOOD MANUFACTURING PRACTICESPRACTICES

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Steven C SeidemanSteven C SeidemanExtension Food Processing SpecialistExtension Food Processing Specialist

Cooperative Extension ServiceCooperative Extension ServiceUniversity of ArkansasUniversity of Arkansas

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INTRODUCTIONINTRODUCTION

This modules covers the Good This modules covers the Good Manufacturing Practices, known as GMPs, Manufacturing Practices, known as GMPs, which are the regulations that cover FDA which are the regulations that cover FDA facilities with regard to operational facilities with regard to operational sanitation. sanitation. The exact regulations can be found by The exact regulations can be found by going to the following website;going to the following website;

www.gpoaccess.gov/topics/food/htmlwww.gpoaccess.gov/topics/food/html.. Click on title 21 and then go to Part 110.Click on title 21 and then go to Part 110.

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CURRENT FDA GOOD CURRENT FDA GOOD MANUFACTURING MANUFACTURING

PRACTICESPRACTICES

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Parts of GMPsParts of GMPs

I. PersonnelI. Personnel

II. Plant and GroundsII. Plant and Grounds

III. Sanitary OperationsIII. Sanitary Operations

IV. Sanitary Facilities and ControlsIV. Sanitary Facilities and Controls

V. Equipment and UtensilsV. Equipment and Utensils

VI. Processes and ControlsVI. Processes and Controls

VII. Warehousing and DistributionVII. Warehousing and Distribution

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I. PERSONNELI. PERSONNEL

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PersonnelPersonnel

Plant management shall take all Plant management shall take all reasonable measures and precautions to reasonable measures and precautions to ensure the following;ensure the following;

a) Disease Controla) Disease Control

b) Cleanlinessb) Cleanliness

c) Education and Trainingc) Education and Training

d) Supervisiond) Supervision

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I. PersonnelI. PersonnelA) Disease ControlA) Disease Control

A) A) Disease ControlDisease Control – Forbids food – Forbids food processing employees from working if they processing employees from working if they show signs of illness, lesions, boils, sores show signs of illness, lesions, boils, sores and other source of microbial and other source of microbial contamination.contamination.

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I. PersonnelI. PersonnelB) CleanlinessB) Cleanliness

B) B) CleanlinessCleanliness- All persons working in - All persons working in direct contact with food, food-contact direct contact with food, food-contact surfaces and food-packaging materials surfaces and food-packaging materials shall conform to hygienic practices while shall conform to hygienic practices while on duty to the extent necessary to protect on duty to the extent necessary to protect against contamination of food. The against contamination of food. The methods for maintaining cleanliness methods for maintaining cleanliness include, but are not limited to the following;include, but are not limited to the following;

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I. Personnel. I. Personnel. B) CleanlinessB) Cleanliness

1) Wearing appropriate outer garments 1) Wearing appropriate outer garments 2) Maintaining adequate personal cleanliness2) Maintaining adequate personal cleanliness3) Washing and sanitizing hands before working 3) Washing and sanitizing hands before working

with foods.with foods.4) Removing all unsecured jewelry and other 4) Removing all unsecured jewelry and other

objects that might fall into food.objects that might fall into food.5) Maintaining gloves, if used in an intact, clean 5) Maintaining gloves, if used in an intact, clean

and sanitary condition.and sanitary condition.6) Wearing hairnets, headbands, caps, beard 6) Wearing hairnets, headbands, caps, beard

covers and other hair restraints. covers and other hair restraints.

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I.I. PersonnelPersonnelB) CleanlinessB) Cleanliness

7) Storing clothing and other personnel belongings 7) Storing clothing and other personnel belongings in areas other than where food is exposed.in areas other than where food is exposed.

8) Confining eating, chewing gum, drinking 8) Confining eating, chewing gum, drinking beverages or using tobacco to areas where food beverages or using tobacco to areas where food will not be exposed.will not be exposed.

9) Taking any other precautionary measures to 9) Taking any other precautionary measures to protect food from microorganisms, and foreign protect food from microorganisms, and foreign substances to include perspiration, hair, substances to include perspiration, hair, cosmetics, tobacco, chemicals and medicines cosmetics, tobacco, chemicals and medicines applied to the skin.applied to the skin.

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I.I. PersonnelPersonnelC) Education and TrainingC) Education and Training

C). C). Education and Training- Education and Training- Personnel responsible Personnel responsible for identifying sanitation failures or food for identifying sanitation failures or food contamination should have a background of contamination should have a background of education or experience or a combination education or experience or a combination thereof, to provide a level of competency thereof, to provide a level of competency necessary for production of clean and safe food. necessary for production of clean and safe food. Food handlers and supervisors should receive Food handlers and supervisors should receive appropriate training in proper food handling appropriate training in proper food handling techniques and food-protection principles and techniques and food-protection principles and should be informed of the danger of poor should be informed of the danger of poor personal hygiene and unsanitary practices.personal hygiene and unsanitary practices.

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I.I. PersonnelPersonnelD) SupervisionD) Supervision

D) D) SupervisionSupervision- Responsibility for assuring - Responsibility for assuring compliance by all personnel with all compliance by all personnel with all requirements under “Personnel” shall be requirements under “Personnel” shall be clearly assigned to competent supervisory clearly assigned to competent supervisory personnel.personnel.

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II. Plant and GroundsII. Plant and Grounds

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II. Plants and GroundsII. Plants and Grounds

Plant and GroundsPlant and Grounds

A) GroundsA) Grounds

B) Plant Construction and DesignB) Plant Construction and Design

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II. Plant and GroundsII. Plant and GroundsA) GroundsA) Grounds

A) A) GroundsGrounds – The grounds about a food – The grounds about a food plant under the control of the operator plant under the control of the operator shall be kept in a condition that will protect shall be kept in a condition that will protect against the contamination of food. The against the contamination of food. The methods for adequate maintenance of methods for adequate maintenance of grounds include, but are not limited to:grounds include, but are not limited to:

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II. Plant and GroundsII. Plant and GroundsA) GroundsA) Grounds

1)1) Properly storing equipment, removing litter and Properly storing equipment, removing litter and waste, and cutting grass and weeds within the waste, and cutting grass and weeds within the immediate vicinity of the plant building that immediate vicinity of the plant building that may constitute an attractant, breeding place or may constitute an attractant, breeding place or harborage for pests.harborage for pests.

2)2) Maintaining roads, yards and parking lotsMaintaining roads, yards and parking lots3)3) Adequately draining areas around the plantAdequately draining areas around the plant4)4) Operating systems for waste management and Operating systems for waste management and

disposal so they do not constitute a source of disposal so they do not constitute a source of contamination.contamination.

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II. Plant and GroundsII. Plant and GroundsB) Plant Construction and DesignB) Plant Construction and Design

B) B) Plant Construction and Design-Plant Construction and Design- Plant Plant buildings and structures shall be suitable buildings and structures shall be suitable in size, construction and design to in size, construction and design to facilitate maintenance and sanitary facilitate maintenance and sanitary operations for food manufacturing operations for food manufacturing purposes. The plant and facilities shall purposes. The plant and facilities shall provide for the following;provide for the following;

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1)1) Provide sufficient space for placement of Provide sufficient space for placement of equipment and storage of materials.equipment and storage of materials.

2)2) Reduce the potential for contamination by Reduce the potential for contamination by safety controls and operating practices or safety controls and operating practices or effective design , including the separation of effective design , including the separation of operations in which contamination is likely to operations in which contamination is likely to occur by one or more of the following means – occur by one or more of the following means – location, time, partition, air flow, enclosed location, time, partition, air flow, enclosed systems or other effective means.systems or other effective means.

3)3) Permit the taking of proper precautions to Permit the taking of proper precautions to protect food in outdoor bulk fermentation protect food in outdoor bulk fermentation vesselsvessels

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4) Facilities should be constructed in a manner 4) Facilities should be constructed in a manner that floors, walls and ceilings can be cleaned, that floors, walls and ceilings can be cleaned, condensate not contaminate food and that aisles condensate not contaminate food and that aisles and work spaces be adequate for employees to and work spaces be adequate for employees to perform their jobs in a sanitary manner.perform their jobs in a sanitary manner.

5) Lighting should be adequate in all parts of the 5) Lighting should be adequate in all parts of the facility and safe-type lightening fixtures should facility and safe-type lightening fixtures should be in place.be in place.

6) Ventilation should be adequate to remove odors 6) Ventilation should be adequate to remove odors and vapors.and vapors.

7) Screens and other protection should be in place 7) Screens and other protection should be in place to protect against pests. to protect against pests.

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A)A) General MaintenanceGeneral Maintenance

B)B) Substances used in CleaningSubstances used in Cleaning

C)C) Pest ControlPest Control

D)D) Sanitation of Food-Contact SurfacesSanitation of Food-Contact Surfaces

E)E) Storage and Handling of Cleaned Storage and Handling of Cleaned Portable Equipment and UtensilsPortable Equipment and Utensils

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III. Sanitary OperationsIII. Sanitary OperationsA) General MaintenanceA) General Maintenance

A) A) General Maintenance-General Maintenance- Buildings, fixtures Buildings, fixtures and other physical facilities of the plant and other physical facilities of the plant shall be maintained in a sanitary condition shall be maintained in a sanitary condition and shall be kept in repair sufficient to and shall be kept in repair sufficient to prevent food from becoming prevent food from becoming contaminated.contaminated.

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III. Sanitary OperationsIII. Sanitary OperationsB) Substances used in CleaningB) Substances used in Cleaning

1)Cleaning compounds and sanitizing agents used shall be 1)Cleaning compounds and sanitizing agents used shall be free from undesirable microorganisms and shall be safe free from undesirable microorganisms and shall be safe and adequate under the conditions of use.and adequate under the conditions of use.

2) Only the following toxic materials may be used or stored 2) Only the following toxic materials may be used or stored in a food plant;in a food plant;

-Those used to maintain clean and sanitary conditions.-Those used to maintain clean and sanitary conditions. - Those necessary to for use in laboratory testing - Those necessary to for use in laboratory testing

procedures.procedures. - Those necessary for plant and equipment maintenance - Those necessary for plant and equipment maintenance

and operationand operation3) Toxic cleaning compounds and pesticide chemicals shall 3) Toxic cleaning compounds and pesticide chemicals shall

be identified, held and stored in a manner that protects be identified, held and stored in a manner that protects against contamination of food.against contamination of food.

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III. Sanitary OperationsIII. Sanitary OperationsC) Pest ControlC) Pest Control

1)1) No pests shall be allowed in an area of a No pests shall be allowed in an area of a food plant.food plant.

2)2) Effective measures shall be taken to Effective measures shall be taken to exclude pests from food processing exclude pests from food processing areas.areas.

3)3) The use of pesticides or rodenticides is The use of pesticides or rodenticides is permitted only under precautions and permitted only under precautions and restrictions that protect against restrictions that protect against contamination of food.contamination of food.

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III. Sanitary OperationsIII. Sanitary OperationsD) Sanitation of Food-Contact D) Sanitation of Food-Contact

SurfacesSurfaces

All food contact surfaces, including All food contact surfaces, including utensils and surfaces of food contact utensils and surfaces of food contact surfaces of equipment , shall be cleaned surfaces of equipment , shall be cleaned as frequently as necessary to protect as frequently as necessary to protect against contamination of food.against contamination of food.

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III. Sanitary OperationsIII. Sanitary OperationsD) Sanitation of Food-Contact D) Sanitation of Food-Contact

SurfacesSurfaces1)1) All food contact surfaces shall be cleaned and All food contact surfaces shall be cleaned and

sanitized before use and after any interruption sanitized before use and after any interruption during which the food contact surfaces may during which the food contact surfaces may have been contaminated. have been contaminated.

2)2) Non-food-contact surfaces of equipment Non-food-contact surfaces of equipment should be cleaned as frequently as necessary should be cleaned as frequently as necessary to protect against contamination.to protect against contamination.

3)3) Sanitizing agents shall be adequate and safe Sanitizing agents shall be adequate and safe under the conditions of use.under the conditions of use.

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III. Sanitary OperationsIII. Sanitary OperationsE) Storage and Handling of E) Storage and Handling of

Cleaned Portable Equipment and Cleaned Portable Equipment and UtensilsUtensils

E) E) Storage and Handling of Cleaned Storage and Handling of Cleaned Portable Equipment and UtensilsPortable Equipment and Utensils. Cleaned . Cleaned and sanitized equipment and utensils and sanitized equipment and utensils should be stored in a location that protects should be stored in a location that protects food-contact surfaces from contamination.food-contact surfaces from contamination.

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IV. Sanitary Facilities and IV. Sanitary Facilities and ControlsControls

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Sanitary Facilities and ControlsSanitary Facilities and Controls

Each plant shall be equipped with adequate Each plant shall be equipped with adequate sanitation facilities and accommodations sanitation facilities and accommodations including;including;

A) Water SupplyA) Water Supply

B) PlumbingB) Plumbing

C) Sewage DisposalC) Sewage Disposal

D) Toilet FacilitiesD) Toilet Facilities

E) Hand-washing FacilitiesE) Hand-washing Facilities

F) Rubbish and Offal DisposalF) Rubbish and Offal Disposal

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Sanitary Facilities and ControlsSanitary Facilities and ControlsA) Water Supply A) Water Supply

A) A) Water SupplyWater Supply – The water supply must – The water supply must be of sufficient quantity and quality as be of sufficient quantity and quality as needed to maintain the operational needed to maintain the operational sanitation of the facility.sanitation of the facility.

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Sanitary Facilities and ControlsSanitary Facilities and ControlsB) PlumbingB) Plumbing

B) B) PlumbingPlumbing – Plumbing shall be designed and installed – Plumbing shall be designed and installed and maintained to;and maintained to;

1) Carry sufficient water throughout the facility1) Carry sufficient water throughout the facility 2) Properly convey sewage and liquid 2) Properly convey sewage and liquid disposable waste from the plantdisposable waste from the plant 3) Avoid constituting as a source of 3) Avoid constituting as a source of contaminationcontamination 4) Provide adequate floor drainage in all areas.4) Provide adequate floor drainage in all areas. 5) Provide that there is no backflow or cross-5) Provide that there is no backflow or cross- connection between the water supply and discharge connection between the water supply and discharge systemssystems

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Sanitary Facilities and ControlsSanitary Facilities and ControlsC) Sewage DisposalC) Sewage Disposal

C) C) Sewage DisposalSewage Disposal – Sewage disposal – Sewage disposal shall be made into an adequate sewerage shall be made into an adequate sewerage system or disposed of through other system or disposed of through other adequate means.adequate means.

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Sanitary Facilities and ControlsSanitary Facilities and ControlsD) Toilet FacilitiesD) Toilet Facilities

D) D) Toilet FacilitiesToilet Facilities – Each plant shall provide its – Each plant shall provide its employees with adequate, readily accessible employees with adequate, readily accessible toilet facilities.toilet facilities.

1) Maintain facilities in a sanitary manner1) Maintain facilities in a sanitary manner 2) Keeping the facilities in good repair2) Keeping the facilities in good repair 3) Providing self-closing doors3) Providing self-closing doors 4) Providing doors that do not open into areas 4) Providing doors that do not open into areas

where food is exposed to airborne where food is exposed to airborne contamination.contamination.

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Sanitary Facilities and ControlsSanitary Facilities and ControlsE) Hand-Washing FacilitiesE) Hand-Washing Facilities

E) E) Hand-Washing FacilitiesHand-Washing Facilities – Hand-washing – Hand-washing facilities shall be adequate, convenient and be facilities shall be adequate, convenient and be furnished with running water.furnished with running water.

1) Hand-washing and sanitizing facilities at each 1) Hand-washing and sanitizing facilities at each location in the plant where good sanitation location in the plant where good sanitation practices required employees wash/sanitize their practices required employees wash/sanitize their hands.hands.

2) Provide sanitary towel services or drying 2) Provide sanitary towel services or drying devicesdevices

3) Readily understandable signs directing 3) Readily understandable signs directing employees to wash their hands. employees to wash their hands.

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Sanitary Facilities and ControlsSanitary Facilities and ControlsF) Rubbish and Offal DisposalF) Rubbish and Offal Disposal

F) F) Rubbish and Offal DisposalRubbish and Offal Disposal – Rubbish – Rubbish and any offal shall be conveyed, stored and any offal shall be conveyed, stored and disposed of as to minimize the and disposed of as to minimize the development of odor, minimize the development of odor, minimize the potential for the waste becoming an potential for the waste becoming an attractant and harborage or breeding place attractant and harborage or breeding place for pests and protect against for pests and protect against contamination of food, food-contact contamination of food, food-contact surfaces, water supplies and ground surfaces, water supplies and ground surfaces.surfaces.

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a)a) All plant equipment and utensils shall be All plant equipment and utensils shall be so designed and of such material and so designed and of such material and workmanship as to be adequately workmanship as to be adequately cleanable and shall be properly cleanable and shall be properly maintained. All equipment should be so maintained. All equipment should be so installed and maintained as to facilitate installed and maintained as to facilitate the cleaning of the equipment and of all the cleaning of the equipment and of all adjacent spaces.adjacent spaces.

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b) Seams on food-contact surfaces shall be b) Seams on food-contact surfaces shall be smoothly bonded or maintained so as to smoothly bonded or maintained so as to minimize accumulation of food particles, minimize accumulation of food particles, dirt and organic manner and thus minimize dirt and organic manner and thus minimize the opportunity for growth of the opportunity for growth of microorganisms.microorganisms.

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C) Equipment that is in the manufacturing or food-C) Equipment that is in the manufacturing or food-handling area and that does not come into handling area and that does not come into contact with food shall be so constructed that it contact with food shall be so constructed that it can be kept in a clean condition.can be kept in a clean condition.

D) Holding, conveying and manufacturing systems D) Holding, conveying and manufacturing systems shall be of a design and construction that shall be of a design and construction that enables them to be maintained in an appropriate enables them to be maintained in an appropriate sanitary condition.sanitary condition.

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E) Each freezer or cold storage compartment used E) Each freezer or cold storage compartment used to store and hold food capable of supporting the to store and hold food capable of supporting the growth of microorganisms shall be fitted with an growth of microorganisms shall be fitted with an indicating thermometer, temperature-measuring indicating thermometer, temperature-measuring device or temperature-recording device so device or temperature-recording device so installed as to show the temperature accurately installed as to show the temperature accurately within the compartment and should be fitted with within the compartment and should be fitted with an automatic control for regulating temperature an automatic control for regulating temperature or with an automatic alarm system to indicate a or with an automatic alarm system to indicate a significant temperature change in a manual significant temperature change in a manual operation.operation.

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F) Instruments and controls used for measuring, F) Instruments and controls used for measuring, regulating and recording temperatures, pH, regulating and recording temperatures, pH, acidity, water activity or other conditions that acidity, water activity or other conditions that control or prevent the growth of undesirable control or prevent the growth of undesirable microorganisms in food shall be accurate and microorganisms in food shall be accurate and adequately maintained and adequate in number adequately maintained and adequate in number for their designated uses.for their designated uses.

G) Compressed air or other gases mechanically G) Compressed air or other gases mechanically introduced into food or used to clean food-introduced into food or used to clean food-contact surfaces or equipment shall be treated in contact surfaces or equipment shall be treated in such a way that food is not contaminated with such a way that food is not contaminated with unlawful indirect food additives.unlawful indirect food additives.

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A)A) Raw Materials and other IngredientsRaw Materials and other Ingredients

B)B) Manufacturing Operations.Manufacturing Operations.

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All operations in the receiving, inspecting, transporting, All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging and segregating, preparing, manufacturing, packaging and storing of food shall be conducted in accordance with storing of food shall be conducted in accordance with adequate sanitation principles.adequate sanitation principles.Appropriate quality control operations shall be employed Appropriate quality control operations shall be employed to ensure that food suitable for human consumption and to ensure that food suitable for human consumption and that food-packaging materials are safe and suitable.that food-packaging materials are safe and suitable.Overall sanitation of the plant shall be under the Overall sanitation of the plant shall be under the supervision of one or more competent individuals supervision of one or more competent individuals assigned the responsibility of the function.assigned the responsibility of the function.All reasonable precautions shall be taken to ensure that All reasonable precautions shall be taken to ensure that production procedures do not contribute contamination production procedures do not contribute contamination from any source.from any source.

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VI. Processes and ControlsVI. Processes and ControlsA) Raw Materials and other A) Raw Materials and other

IngredientsIngredients 1) Raw materials and other ingredients shall be inspected 1) Raw materials and other ingredients shall be inspected

and segregated or otherwise handled as necessary to and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing ascertain that they are clean and suitable for processing into food and shall be stored under conditions that will into food and shall be stored under conditions that will protect against contamination and minimize protect against contamination and minimize deterioration. Raw materials shall be washed and deterioration. Raw materials shall be washed and cleaned as necessary to remove soil and other cleaned as necessary to remove soil and other contamination. Water used for washing, rinsing or contamination. Water used for washing, rinsing or conveying food shall be safe and of adequate sanitary conveying food shall be safe and of adequate sanitary quality. Containers and carriers of raw materials should quality. Containers and carriers of raw materials should be inspected on receipt to ensure that their condition has be inspected on receipt to ensure that their condition has not contributed to contamination or deterioration of food.not contributed to contamination or deterioration of food.

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IngredientsIngredients2) Raw materials and other ingredients shall either 2) Raw materials and other ingredients shall either

not contain levels of microorganisms that may not contain levels of microorganisms that may produce food poisoning or other disease in produce food poisoning or other disease in humans or they shall be pasteurized or humans or they shall be pasteurized or otherwise treated during manufacturing otherwise treated during manufacturing operations so that they no longer contain levels operations so that they no longer contain levels that would cause the product to be adulterated. that would cause the product to be adulterated. Compliance with this requirement may be Compliance with this requirement may be verified by any effective means including verified by any effective means including purchasing raw materials and other ingredients purchasing raw materials and other ingredients under a supplier’s guarantee or certification.under a supplier’s guarantee or certification.

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IngredientsIngredients3) Raw materials, other ingredients and rework susceptible 3) Raw materials, other ingredients and rework susceptible

to contamination with pests, undesirable microorganisms to contamination with pests, undesirable microorganisms or extraneous material shall comply with applicable FDA or extraneous material shall comply with applicable FDA regulations, guidelines and defect action levels for regulations, guidelines and defect action levels for natural or unavoidable defects if a manufacturer wishes natural or unavoidable defects if a manufacturer wishes to use the materials in manufacturing food. Compliance to use the materials in manufacturing food. Compliance with this requirement may be verified by any effective with this requirement may be verified by any effective means including purchasing the material under a means including purchasing the material under a supplier’s guarantee or certification or examination of supplier’s guarantee or certification or examination of these materials for contamination.these materials for contamination.

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IngredientsIngredients4) Raw materials and rework shall be held in 4) Raw materials and rework shall be held in

bulk or in containers designed and bulk or in containers designed and constructed so as to protect against constructed so as to protect against contamination and shall be held at such contamination and shall be held at such temperatures and relative humidity and in temperatures and relative humidity and in such a manner as to prevent food from such a manner as to prevent food from becoming adulterated. Material scheduled becoming adulterated. Material scheduled for rework shall be identified as such. for rework shall be identified as such.

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IngredientsIngredients

5) Frozen raw materials and other ingredients shall 5) Frozen raw materials and other ingredients shall be kept frozen. If thawing is required prior to be kept frozen. If thawing is required prior to use, it shall be done in a manner that prevents use, it shall be done in a manner that prevents the raw materials and other ingredients from the raw materials and other ingredients from becoming adulterated.becoming adulterated.

6) Liquid or dry raw materials and other ingredients 6) Liquid or dry raw materials and other ingredients received and stored in bulk form shall be held in received and stored in bulk form shall be held in a manner that protects against contamination.a manner that protects against contamination.

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VI. Processes and ControlsVI. Processes and ControlsB) Manufacturing OperationsB) Manufacturing Operations

1)1) Equipment and utensils and finished food Equipment and utensils and finished food containers shall be maintained in an containers shall be maintained in an acceptable condition through appropriate acceptable condition through appropriate cleaning and sanitizing as necessary. cleaning and sanitizing as necessary. Insofar as necessary, equipment shall be Insofar as necessary, equipment shall be taken apart for thorough cleaning.taken apart for thorough cleaning.

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2) All food manufacturing shall be conducted under such 2) All food manufacturing shall be conducted under such conditions and controls as are necessary to minimize the conditions and controls as are necessary to minimize the potential for the growth of microorganism or for the potential for the growth of microorganism or for the contamination of food. One way to comply with this contamination of food. One way to comply with this requirement is careful monitoring the physical factors requirement is careful monitoring the physical factors such as time, temperature, humidity, Aw, pH, pressure, such as time, temperature, humidity, Aw, pH, pressure, flow rate and manufacturing operations such as freezing, flow rate and manufacturing operations such as freezing, dehydration, heat processing, acidification and dehydration, heat processing, acidification and refrigeration to ensure that mechanical breakdowns, time refrigeration to ensure that mechanical breakdowns, time delays, temperature fluctuations and other factors do not delays, temperature fluctuations and other factors do not contribute to the decomposition or contamination of food.contribute to the decomposition or contamination of food.

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3) Food that can support the rapid growth of undesirable 3) Food that can support the rapid growth of undesirable microorganisms, particularly those of public health microorganisms, particularly those of public health significance, shall be held in a manner that prevents the significance, shall be held in a manner that prevents the food from becoming adulterated. Compliance with this food from becoming adulterated. Compliance with this requirement may be accomplished by any effective requirement may be accomplished by any effective means including;means including;

a) Maintaining refrigerated foods at 45F or below.a) Maintaining refrigerated foods at 45F or below. b) Maintaining frozen foods in a frozen stateb) Maintaining frozen foods in a frozen state c) Maintaining hot foods at 140F or abovec) Maintaining hot foods at 140F or above d) Heat treating acid or acidified foods when those foods d) Heat treating acid or acidified foods when those foods

are to be held in containers at ambient temperatures.are to be held in containers at ambient temperatures.

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4) Measures such as sterilizing, irradiating, 4) Measures such as sterilizing, irradiating, pasteurizing, freezing, refrigeration, pasteurizing, freezing, refrigeration, controlling pH or controlling Aw that are controlling pH or controlling Aw that are taken to destroy or prevent the growth of taken to destroy or prevent the growth of undesirable microorganisms , shall be undesirable microorganisms , shall be adequate under the conditions of adequate under the conditions of manufacturing, handling and distribution to manufacturing, handling and distribution to prevent food from being adulteratedprevent food from being adulterated

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5) Effective measures shall be taken to protect 5) Effective measures shall be taken to protect finished food from contamination by raw finished food from contamination by raw materials other ingredients or refuse. When raw materials other ingredients or refuse. When raw materials, other ingredients or refuse are materials, other ingredients or refuse are unprotected, they shall be handled unprotected, they shall be handled simultaneously in a receiving, loading or simultaneously in a receiving, loading or shipping area if that handling could result in shipping area if that handling could result in contaminated food. Food transported by contaminated food. Food transported by conveyor shall be protected against conveyor shall be protected against contamination as necessary.contamination as necessary.

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6) Equipment, containers and utensils used 6) Equipment, containers and utensils used to convey, hold or store raw materials, to convey, hold or store raw materials, work-in-progress, rework or food shall be work-in-progress, rework or food shall be constructed, handled and maintained constructed, handled and maintained during manufacturing or storage in a during manufacturing or storage in a manner that protects against manner that protects against contaminationcontamination

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7) Effective measures shall be taken to 7) Effective measures shall be taken to protect against the inclusion of metal or protect against the inclusion of metal or other extraneous material in food. other extraneous material in food. Compliance with this requirement may be Compliance with this requirement may be accomplished by using sieves, traps, accomplished by using sieves, traps, magnets, electronic metal detectors or magnets, electronic metal detectors or other suitable effective means.other suitable effective means.

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8) Food, raw materials and other ingredients 8) Food, raw materials and other ingredients that are adulterated shall be disposed of in that are adulterated shall be disposed of in a manner that protects against the a manner that protects against the contamination of other food. If the contamination of other food. If the adulterated food is capable of being adulterated food is capable of being reconditioned, it shall be reconditioned reconditioned, it shall be reconditioned using a method that has been proven to using a method that has been proven to be effective or it shall be reexamined and be effective or it shall be reexamined and found not to be adulterated before being found not to be adulterated before being incorporated into other food.incorporated into other food.

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9) Mechanical manufacturing steps such as washing, 9) Mechanical manufacturing steps such as washing, peeling, trimming, cutting, sorting and inspection, peeling, trimming, cutting, sorting and inspection, mashing, dewatering, cooling, shredding, extruding, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting and forming shall be drying, whipping, defatting and forming shall be performed so as to protect food against contamination. performed so as to protect food against contamination. Compliance with requirement may be accomplished by Compliance with requirement may be accomplished by providing adequate physical protection of food from providing adequate physical protection of food from contaminants that may drip, drain or be drawn into food. contaminants that may drip, drain or be drawn into food. Protection may be provided by adequate cleaning and Protection may be provided by adequate cleaning and sanitizing of all food-contact surfaces and by using time sanitizing of all food-contact surfaces and by using time and temperature controls at and between each and temperature controls at and between each manufacturing stepmanufacturing step

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10) Heat blanching, when required in the 10) Heat blanching, when required in the preparation of food, should be effected by preparation of food, should be effected by heating the food to the required temperature, heating the food to the required temperature, holding it at this temperature for the required holding it at this temperature for the required time and then either rapidly cooling the food or time and then either rapidly cooling the food or passing it to subsequent manufacturing without passing it to subsequent manufacturing without delay. Contamination in blanchers should be delay. Contamination in blanchers should be minimized by the use of adequate operating minimized by the use of adequate operating temperatures and by periodic cleaning.temperatures and by periodic cleaning.

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11) Batters, breadings, sauces, gravies, dressings and 11) Batters, breadings, sauces, gravies, dressings and other similar preparations shall be treated or maintained other similar preparations shall be treated or maintained in such a manner that they are protected against in such a manner that they are protected against contamination. Compliance with this requirement may be contamination. Compliance with this requirement may be accomplished by any effective means including one or accomplished by any effective means including one or more of the following;more of the following;

a) Using ingredients free of contaminationa) Using ingredients free of contamination b) Employing adequate heat processesb) Employing adequate heat processes c) Using adequate time and temperature controlsc) Using adequate time and temperature controls d) Providing physical protection of components from drip, d) Providing physical protection of components from drip,

drain or be drawn into themdrain or be drawn into them f) Cooling to adequate temperature during manufacturingf) Cooling to adequate temperature during manufacturing

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12) Filling, assembling, packaging and other operations shall be 12) Filling, assembling, packaging and other operations shall be performed in such a way that the food is protected against performed in such a way that the food is protected against contamination. Compliance can be accomplished by;contamination. Compliance can be accomplished by;

a) Use of a quality control operation in which the critical control a) Use of a quality control operation in which the critical control points are identified and controlled during manufacturing.points are identified and controlled during manufacturing. b) Adequate cleaning and sanitizing of all food-contact surfaces and b) Adequate cleaning and sanitizing of all food-contact surfaces and food containers.food containers. c) Using food containers and food packaging materials that are safe c) Using food containers and food packaging materials that are safe and suitable.and suitable. d) Providing physical protection from contamination, particularly d) Providing physical protection from contamination, particularly airborne contamination.airborne contamination. e) Using sanitary handling procedures.e) Using sanitary handling procedures.

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13) Foods such as dry mixes, nuts, intermediate moisture 13) Foods such as dry mixes, nuts, intermediate moisture food and dehydrated food that relies on control of Aw for food and dehydrated food that relies on control of Aw for preventing the growth of undesirable microorganisms preventing the growth of undesirable microorganisms shall be processed to and maintained at a safe moisture shall be processed to and maintained at a safe moisture level. Compliance with this requirement can be level. Compliance with this requirement can be accomplished by one or more of the following;accomplished by one or more of the following;

a) Monitoring the Aw.a) Monitoring the Aw. b) Controlling the soluble solids-water ratio in finished b) Controlling the soluble solids-water ratio in finished

food.food. c) Protecting finished foods from moisture pickup by use c) Protecting finished foods from moisture pickup by use

of a moisture barrier or by other means so that the Aw of of a moisture barrier or by other means so that the Aw of the food does not increase to an unsafe level.the food does not increase to an unsafe level.

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14) Foods such as acid or acidified foods that 14) Foods such as acid or acidified foods that relies principally on the control of pH for relies principally on the control of pH for preventing the growth of undesirable preventing the growth of undesirable microorganisms shall be monitored and microorganisms shall be monitored and maintained at a pH of 4.6 or below. Compliance maintained at a pH of 4.6 or below. Compliance can be accomplished by one or more of the can be accomplished by one or more of the following;following;

a) Monitoring the pH of raw materials, food in a) Monitoring the pH of raw materials, food in process and finished food.process and finished food.

b) Controlling the amount of acid or acidified b) Controlling the amount of acid or acidified food added to low-acid foodsfood added to low-acid foods

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15) When ice is used in contact with food, it 15) When ice is used in contact with food, it shall be made from water that is safe and shall be made from water that is safe and of adequate sanitary quality and shall be of adequate sanitary quality and shall be used only if it has been manufactured in used only if it has been manufactured in accordance with good manufacturing accordance with good manufacturing practices.practices.

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16) Food-manufacturing areas and 16) Food-manufacturing areas and equipment used for manufacturing human equipment used for manufacturing human food should not be used to manufacture food should not be used to manufacture nonhuman food-grade animal feed or nonhuman food-grade animal feed or inedible products unless there is no inedible products unless there is no reasonable possibility for the reasonable possibility for the contamination of the human food.contamination of the human food.

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VII. Warehousing and DistributionVII. Warehousing and Distribution

Storage and transportation of finished food Storage and transportation of finished food shall be under conditions that will protect shall be under conditions that will protect food against physical, chemical and food against physical, chemical and microbial contamination as well as against microbial contamination as well as against deterioration of the food and the container.deterioration of the food and the container.

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SUMMARYSUMMARY

This module has covered the FDAs Good This module has covered the FDAs Good Manufacturing Practices (GMPs) that are Manufacturing Practices (GMPs) that are aimed at producing safe food that are free aimed at producing safe food that are free of physical, chemical and microbial of physical, chemical and microbial contamination.contamination.

The FDA is currently inviting comments to The FDA is currently inviting comments to these GMPs so that they can be updated these GMPs so that they can be updated in the near future.in the near future.

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Date post:	28-Mar-2015
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1 GOOD MANUFACTURING PRACTICES 2214 Steven C Seideman Extension Food Processing Specialist...

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