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2017
Current Good Manufacturing Practices for Food
Title 21 Code of Federal Regulations (CFR) Part 117, Subpart B
Presented By:
California Department of Public Health Food and Drug Branch
Phone (916) 650-6500 Email [email protected]
Presentation Goals
Key Terms
Four Major Components
Questions
Key Terms
Must* mandatory. Replaced shall,which was defined
Adequate what is needed to accomplish the intended
purpose in keeping with good public health practice
Should and all advisory languageremoved
Suitable* adapted to a use or purpose; proper; able; qualified * Dictionary
Definitions
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mailto:[email protected]
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GOOD MANUFACTURING PRACTICES
Sanitary Controls and Conditions
Processing Controls ADEQUATE
SUITABLE
GMP Triple Threat Food
Food Contact Surfaces
Food Packaging and Materials
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Buildings, fixtures, and physical facilities must be maintained in a sanitary condition and in repair adequate to prevent contamination 21 CFR 117.35(a)
Grounds The grounds under control of the operator must be maintained in a manner to protect against the contamination of food.
21 CFR 117.20(a)(1-4)
Storing equipment Litter and waste
Weeds and grass Roads and yards
Drainage Waste systems
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Grounds The grounds not under control of the operator and not adequately maintained: care shall be exercised to prevent food contamination through:
117.20(a)(5)
Inspection Extermination Other means
Facilities Buildings and structures must be of suitable size, construction, and design to facilitate maintenance and sanitary operations
117.20(b)(1), (2)
Space for equipment and storage Food safety + allergen controls Operating practices Effective design Other effective means
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What do you see?
Bad News
- pest droppings
Good News
- visual inspection
Your facility design must allow for product protection via either:
Partition Space Time
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Facilities
Plant buildings and structures must be suitable in size, construction and design to facilitate maintenance and sanitary operations. 117.20(b)(5)
Adequate lighting
Safety fixtures
Facilities Buildings and structures must be of suitable size, construction, and design to facilitate maintenance and sanitary operations
117.20(b)(3)
Outdoor Bulk Vessels Construction
- adequately cleaned - adequate space - good repair 117.35(a)
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Facilities Buildings and structures must be of suitable size construction and design to facilitate maintenance and sanitary operations
117.20(b)(4)
Construction - drip and condensate
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Facilities
Buildings and structures must be suitable in size, construction and design to facilitate maintenance and sanitary operations.
117.20(b)(6)
Adequate ventilation
Sanitary Facilities 117.37(b), (c), (f)
Each plant must be equipped with adequate sanitary facilities: -Plumbing
-Properly sized -Avoid being a source of contamination -Floor Drainage -No Back flow or Cross connections
- Sewage Disposal - Rubbish and offal disposal
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Water Supply 117.37(a) Adequate Source Safe and Sanitary Quality Suitable Temperature Appropriate Pressure
117.80(b)(1) Water used for washing, rinsing, or conveying food must be of safe and sanitary quality Water, if reused cannot increase the level of contamination in food
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Sanitary Facilities 117.37(d)
Toilet Facilities - Adequate, readily accessible - Must be kept clean - Must not be a potential source of contamination
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Sanitary Facilities 117.37(e)
Handwashing Facilities To ensure hands are not a source of
contamination
Adequate (soap, towels) Convenient Running water at suitable temperature
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Facilities and Grounds
Sanitary Facilities (110.37 e)Handwashing Facilities
- Cleaning and Sanitizing Agents
- Sanitary Towel or hand drying devices
- Signs- Refuse containers
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Pest Control 117.20(b)(7)
Provide adequate screening or other protection against pests.
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Pest Control 117.35(c)
No pests allowed in plant Take effective measures to exclude from processing areas Pesticide use permitted only under precautions + restrictions
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Why are good personnel practices
necessary?
Personnel 117.10(a) Management must take reasonable measures
to ensure:
Disease control - Medical Exam - Observation - Exclusion - Reporting
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Personnel 117.10(b) Management must take reasonable measures
to ensure:
Cleanliness through hygienic practices
Outer garments
Personal cleanliness
Washing hands thoroughly
Personnel 117.10(b) Management must take reasonable measures
to ensure:
Cleanliness through hygienic practices Jewelry Clothing storage areas
Gloves Confine eating, drinking, smoking Hair restraints Allergen cross-contact
Foreign substances
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Personnel Management must take reasonable measures
to ensure:
Education and Training 117.4(b) and (d), and 117.9
Proper Supervision 117.4(b) and (c)
Im the boss here!
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Equipment Must be designed and of such material, and workmanship to be adequately cleanable and maintained. 117.40 Avoid adulteration with:
- lubricants - fuel - metal fragments - contaminated water
Facilitate cleaning and maintenance
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Equipment 117.40(a), (b)
Designed to withstand food, cleaning and sanitizing
Smoothly bonded seams
Taken apart for thorough cleaning 117.80(c)(1)
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Equipment 117.40(a)
Must be: Installed and maintained to facilitate cleaning Corrosion resistant Non-toxic
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Equipment
Non-food contact surfaces
Constructed to be kept clean 117.40(c)
Cleaned as necessary to protect against allergen cross-contact and contamination 117.35(e)
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Equipment 117.40(e)
Accurate temperature measuring or recording devices required for freezers and cold storage units
Equipment 117.40(f) and (g) Instruments and controls for measuring conditions that prevent the growth of microorganisms must be:
- accurate and precise - maintained - adequate in number
Compressed air must not be a source of contamination
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Sanitary Operations 117.35(a)
Cleaning and sanitizing of utensils and equipment must be conducted in a manner that protects against allergen cross-contact and contamination
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Sanitary Operations 117.35(b)(1)
Cleaning and sanitizing agents must be: - Free from microorganisms - Safe - Adequate
Must be Verified by either: Letter of Guarantee, Certification, or, Examination
Sanitary Operations 117.35(b)
Use or store toxic agents only for:
- Cleaning and sanitizing - Laboratory - Maintenance and operations
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Sanitary Controls 117.35(b)(2)
Toxic Agents must be: Identified: Labels! Held and stored to protect
against contamination
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Sanitation of Food Contact Surfaces 117.35(d)
Must be cleaned as frequently as necessary to protect from allergen cross-contact and contamination.
Wet Sanitation Dry Sanitation
Sanitation of Food Contact Surfaces 117.35
Single service articles 117.35(d)
Sanitizing agents 117.35(e)
Portable equipment 117.35(f)
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Processes and Controls 117.80
All operations must be conducted in accordance with adequate sanitation principles
Appropriate quality control operations must be employed
Adequate precautions must be taken to protect from allergen cross-contact and contamination
Processes and Controls 117.80(b)(2)
Ingredients must not contain levels of microorganisms that may be injurious to health,
or
Ingredients must be pasteurized or otherwise treated.
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Receiving
Holding
Manufacturing
Distribution
Packaging/Labeling
Storage
Raw Materials
Manufacturing Operations
Raw Materials 117.80(b)(1)
Must be: Inspected, segregated or handled as
necessary, to determine they are clean and suitable
Stored while protecting from allergen cross-contact and contamination, and minimizing deterioration
Washed and cleaned, as necessary, to remove contaminants
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Acceptable food storage practice?
Raw Materials 117.80(b)(1)
Raw Materials and Ingredients must be inspected to ensure they are clean and suitable, and stored in a way to prevent allergen cross-contact, contamination, and deterioration.
Raw Materials 117.80(b)(3)
Susceptible to aflatoxin or other natural toxins must comply with FDA regulations, guidelines, and action levels.
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Raw Materials 117.80(b)(4), 117.110
Susceptible to pests or other undesirable microorganisms or extraneous materials shall comply with FDA defect action levels.
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Raw Materials 117.80(b)(5), (b)(7)
Held in bulk containers must be held while protecting from allergen cross-contact, contamination, and adulteration
Materials scheduled for re-work must be identified as such
Raw Materials 117.80(b)(6)
Frozen ingredients must be kept frozen. If thawed, it must be done in a manner that prevents adulteration.
Manufacturing Operations 117.80(c)(2)
Comply by monitoring: Physical Factors Manufacturing Time Freezing Flow Rate Dehydration Aw Heat Processing pH Acidification Temperature Refrigeration Pressure Irradiation Humidity
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Manufacturing Operations 117.80(c)(2)
All food manufacturing, including packaging and storage, must be conducted under conditions and controls necessary to minimize the potential for growth of microorganisms, allergen cross-contact, contamination, and deterioration.
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Manufacturing Operations 117.80(c)(3)
FOODS THAT CAN SUPPORT THE RAPID GROWTH OF UNDESIRABLE MICROORGANISMS MUST BE HELD AND PROCESSED IN A MANNER THAT PREVENTS THE FOOD FROM BECOMING ADULTERATED
Manufacturing Operations H&SC 110980, 21 CFR 117.80(c)(3)
Refrigerated foods at < 45oF Frozen foods in frozen state Heat treating or acidifying foods held
at ambient temperatures in hermetically sealed containers
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Exercise
Additional Considerations Hazard Analysis and Risk Based Preventive
Controls
Food Allergen/Sanitation/Supply-Chain Controls
Recall Plan
Environmental Monitoring Program
Reportable Food Registry
FDA Bioterrorism Registration
Validation of Processes
Audit Programs (ISO/BRC/ETC)
Contacts State Government
CDPH-Food and Drug Branch P.O. Box 997435; MS 7602 Sacramento, CA 95899-7435 E-mail: [email protected] (916) 650-6500
California Department of Food and Agriculture 1220 N Street Sacramento, California, U.S.A. 95814 www.cdfa.ca.gov (916) 654-0466
Federal Government
U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov 1-888-INFO-FDA (1-888-463-6332)
U.S. Department of Food and Agriculture 620 Central Avenue, Building 2C Alameda, CA 94501 www.fsis.usda.gov (510) 337-5000 (Alameda District)
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http:www.fsis.usda.govhttp:www.fda.govhttp:www.cdfa.ca.govmailto:FDBtraining@cdph.ca.govwww.cdfa.ca.govwww.fda.govwww.fsis.usda.gov
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Structure BookmarksCurrent Good Manufacturing Practices for Food FigureTitle 21 Code of Federal Regulations (CFR) Part 117, Subpart B Title 21 Code of Federal Regulations (CFR) Part 117, Subpart B
Presented By: California Department of Public Health Food and Drug Branch Phone (916) 650-6500 Email [email protected]
Presentation Goals Presentation Goals Key Terms Four Major Components Questions Must* mandatory. Key Replaced shall,Terms which was defined Should and which was defined Should and which was defined Should and Adequate what is needed to
all advisory
accomplish the intended languagepurpose in keeping with good removed public health practice Suitable* adapted to a use or * Dictionary purpose; proper; able; qualified Definitions * Dictionary purpose; proper; able; qualified Definitions
OOD MANUFACTURING PRACTICES G
Sanitary Controls and Conditions Processing Controls ADEQUATE SUITABLE GMP Triple Threat Food Food Contact Surfaces Food Packaging and Materials FigureBuildings, fixtures, and physical facilities must be maintained in a sanitary condition and in repair adequate to prevent contamination 21 CFR 117.35(a) FigureGrounds The grounds of the operator must be maintained in a manner to protect against the contamination of food. under control
21 CFR 117.20(a)(1-4) Storing equipment Litter and waste Weeds and grass Roads and yards Drainage Waste systems 2017 Grounds The grounds of the operator and : care shall be exercised to prevent food contamination through: not under control not adequately maintained
117.20(a)(5) Inspection Extermination Other means FigureFacilities Buildings and structures must be of suitable size, construction, and design to facilitate maintenance and sanitary operations 117.20(b)(1), (2) Space for equipment and storage
Food safety + allergen controls
Operating practices
Effective design
Other effective means
FigureFigureFigureWhat do you see? Bad News -pest droppings Good News -visual inspection Partition Space Time Your facility design must allow for product protection via either: Facilities Plant buildings and structures must be suitable in size, construction and design to facilitate maintenance and sanitary operations. 117.20(b)(5) Adequate lighting
Safety fixtures
FigureFacilities Buildings and structures must be of suitable size, construction, and design to facilitate maintenance and sanitary operations 117.20(b)(3) Outdoor Bulk Vessels Construction -adequately cleaned -adequate space 117.35(a) -good repair
Facilities Buildings and structures must be of suitable size construction and design to facilitate maintenance and sanitary operations 117.20(b)(4) Construction -drip and condensate -drip and condensate Facilities
FigureFigureFigureBuildings and structures must be suitable in size, construction and design to facilitate maintenance and sanitary operations. 117.20(b)(6) Adequate ventilation Sanitary Facilities 117.37(b), (c), (f) Each plant must be equipped with adequate sanitary facilities: -Plumbing -Properly sized -Avoid being a source of contamination -Floor Drainage -No Back flow or Cross connections -Sewage Disposal -Rubbish and offal disposal 2017 FigureFigureWater Supply Water Supply 117.37(a) AdequateAdequateAdequate Source
SafeSafe and Sanitary Quality
SuitableSuitable Temperature
AppropriateAppropriate Pressure
117.80(b)(1) WaterWaterWater used for washing, rinsing, or conveying food must be of safe and sanitary quality
Water, Water, if reused cannot increase the level of contamination in food
FigureFigureFigure117.37(d) Sanitary Facilities
Toilet Facilities -Adequate, readily accessible -Must be kept clean -Must not be a potential source of contamination -Adequate, readily accessible -Must be kept clean -Must not be a potential source of contamination Sanitary Facilities 117.37(e)
FigureFigureFigureHandwashing Facilities
To ensure hands are not a source of contamination
Adequate (soap, towels)
Convenient
Running water at suitable temperature
FigureFigure117.20(b)(7) Pest Control
Provide adequate screening or other protection against pests. FigureFigure117.35(c) Pest Control
No pests allowed in plant
Take effective measures to exclude from processing areas
Pesticide use permitted only under precautions + restrictions
FigureFigureWhy are good personnel practices necessary? 117.10(a) Personnel
Management must take reasonable measures to ensure: Disease control -Medical Exam -Observation -Exclusion -Reporting 117.10(b) Personnel
Management must take reasonable measures to ensure: Cleanliness through hygienic practices OuterOuterOuter garments
PersonalPersonal cleanliness
WashingWashing hands thoroughly
Figure117.10(b) Personnel
Management must take reasonable measures to ensure: Cleanliness through hygienic practices Jewelry Jewelry Jewelry Clothing storage areas
Gloves Gloves Confine eating, drinking,
Hair restraints Hair restraints smoking
TRAllergen cross-contact
TRForeign substances
FigureFigureFigureFigurePersonnel Management must take reasonable measures to ensure:
Education and Training Education and Training 117.4(b) and (d), and 117.9
Proper Supervision Proper Supervision 117.4(b) and (c) Im the boss here! FigureEquipment Must be designed and of such material, and workmanship to be adequately cleanable and maintained. 117.40 Avoid adulteration with: -lubricants -fuel -metal fragments -contaminated water
Facilitate cleaning and maintenance
FigureEquipment 117.40(a), (b) Designed to withstand food, cleaning and sanitizing
Smoothly bonded seams
Taken apart for thorough cleaning 117.80(c)(1)
FigureFigureFigureEquipment 117.40(a) Must be: Installed and maintained to facilitate cleaning
Corrosion resistant
Non-toxic
FigureEquipment Non-food contact surfaces Constructed to be kept clean 117.40(c) Cleaned as necessary to protect against allergen cross-contact and contamination 117.35(e) FigureFigure117.40(e) Equipment
Accurate temperature measuring or recording devices required for freezers and cold storage units Figure117.40(f) and (g) Equipment
Instruments and controls for measuring conditions that prevent the growth of microorganisms must be: -accurate and precise -maintained -adequate in number Compressed air must not be a source of contamination Figure117.35(a) Sanitary Operations
Cleaning and sanitizing of utensils and equipment must be conducted in a manner that protects against allergen cross-contact and contamination FigureFigure117.35(b)(1) Sanitary Operations
Cleaning and sanitizing agents must be: -Free from microorganisms -Safe -Adequate Must be Verified by either: Letter of Guarantee,
Certification, or,
Examination
117.35(b) Sanitary Operations
Use or store toxic agents only for: -Cleaning and sanitizing -Laboratory -Maintenance and operations Figure117.35(b)(2) Sanitary Controls
Toxic Agents must be: Identified: Labels!
Held and stored to protect against contamination
FigureFigureSanitation of Food Contact Surfaces 117.35(d) Must be cleaned as frequently as necessary to protect from allergen cross-contact and contamination. Wet Sanitation
Dry Sanitation
Sanitation of Food Contact Surfaces 117.35 Single service articles Single service articles Single service articles 117.35(d)
Sanitizing agents Sanitizing agents 117.35(e)
Portable equipment Portable equipment 117.35(f)
FigureProcesses and Controls 117.80 operations must be conducted in accordance with adequate sanitation principles All
quality control operations must be employed Appropriate
precautions must be taken to protect from allergen cross-contact and contamination Adequate
Processes and Controls 117.80(b)(2) Ingredients must not contain levels of microorganisms that may be injurious to health, or Ingredients must be pasteurized or otherwise treated. Receiving Holding Manufacturing Distribution Packaging/Labeling Storage Raw Materials
Manufacturing Operations Manufacturing Operations Raw Materials 117.80(b)(1) Must be: Inspected, segregated or handled as necessary, to determine they are clean and suitable Stored while protecting from allergen cross-contact and contamination, and minimizing deterioration Washed and cleaned, as necessary, to remove contaminants Acceptable food storage practice? Raw Materials 117.80(b)(1) Raw Materials and Ingredients must be inspected to ensure they are clean and suitable, and stored in a way to prevent allergen cross-contact, contamination, and deterioration. Raw Materials 117.80(b)(3) Susceptible to aflatoxin or other natural toxins must comply with FDA regulations, guidelines, and action levels. Figure
Raw Materials Raw Materials 117.80(b)(4), 117.110 Susceptible to pests or other undesirable microorganisms or extraneous materials shall comply with FDA defect action levels. Figure
Raw Materials Raw Materials 117.80(b)(5), (b)(7) Held in bulk containers must be held while protecting from allergen cross-contact, contamination, and adulteration
Materials scheduled for re-work must be identified as such
Raw Materials Raw Materials 117.80(b)(6) Frozen ingredients must be kept frozen. If thawed, it must be done in a manner that prevents adulteration. Manufacturing Operations 117.80(c)(2) Comply by monitoring: Physical Factors Manufacturing Physical Factors Manufacturing
Time Freezing Flow Rate Dehydration Aw Heat Processing pH Acidification Temperature Refrigeration Pressure Irradiation Humidity
Manufacturing Operations Manufacturing Operations 117.80(c)(2) All food manufacturing, including packaging and storage, must be conducted under conditions and controls necessary to minimize the potential for growth of microorganisms, allergen cross-contact, contamination, and deterioration. FigureFigure
Manufacturing Operations Manufacturing Operations 117.80(c)(3) FOODS THAT CAN SUPPORT THE RAPID GROWTH OF UNDESIRABLE MICROORGANISMS MUST BE HELD AND PROCESSED IN A MANNER THAT PREVENTS THE FOOD FROM BECOMING ADULTERATED
Manufacturing Operations Manufacturing Operations H&SC 110980, 21 CFR 117.80(c)(3) Refrigerated foods at 45F < o
Frozen foods in frozen state
Heat treating or acidifying foods held at ambient temperatures in hermetically sealed containers
FigureExercise Additional Considerations Hazard Analysis and Risk Based Preventive Controls
Food Allergen/Sanitation/Supply-Chain Controls
Recall Plan
Environmental Monitoring Program
Reportable Food Registry
FDA Bioterrorism Registration
Validation of Processes
Audit Programs (ISO/BRC/ETC)
Contacts Contacts State Government State Government
CDPH-Food and Drug Branch P.O. Box 997435; MS 7602 Sacramento, CA 95899-7435 E-mail: (916) 650-6500 [email protected] [email protected]
California Department of Food and Agriculture 1220 N Street Sacramento, California, U.S.A. 95814 www.cdfa.ca.gov www.cdfa.ca.gov www.cdfa.ca.gov
(916) 654-0466 Federal Government Federal Government
U.S.Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov www.fda.gov www.fda.gov
1-888-INFO-FDA (1-888-463-6332) U.S. Department of Food and Agriculture 620 Central Avenue, Building 2C Alameda, CA 94501 www.fsis.usda.gov www.fsis.usda.gov www.fsis.usda.gov
(510) 337-5000 (Alameda District) Figure2017 Figure