Professional Documents
Culture Documents
cGMP
FACILITIES
CHEMICAL
CONTROL
WAREHOUSING
AND
DISTRIBUTION
HACCP
PREMISES
SSOP
EQUIPMENT
PERSONAL
HYGIENE
TRACEABILITY
AND
RECALL
SUPPLIER
CONTROL
INGREDIENTS
AND
RAW MATERIALS
CLEANLINESS
AND
SANITATION
PEST CONTROL
cont
sets of
principles on
controls,
conditions for
quality and
hygienic
handling/processi
ng/ service of
foods
cGMP
FACILITIES
HACCP
SSOP
Facilities
building
sanitary facilities
lighting
floors, walls, ceilings, doors
ventilation
water supply
waste disposal system
Facilities
Things to consider:
- design
- materials
- construction
- layout
Facilities
Building
Must be designed & constructed to
ensure:
- hygienic food handling
- effective cleaning & sanitation
- prevention of entry of pests
- safety of personnel
Facilities
Building
Location, construction,
maintenance
according to sanitary
design principles
cleaned on a regular
basis
Lay-out follows a
straight-line process
flow
Facilities
Building
Areas of a Plant:
Receiving area
Ingredient storage
area
Processing area
Finished product
warehousing area
Toilet area
Plant Lay-out
Facilities
Main entrance
A simple
Laboratory
factory layout
with all
departments
housed within a
single
compound
Administration
Production Area
Raw
materials
EA = Employee amenities
FPS = Finished Products Storage
EA
FPS
Final
products
A
Production Area
A = Administration
L = Laboratory
EA = Employee
amenities
L
EA
Final
products
Facilities
Sanitary Facilities
Supplied with running water
Handwashing sink near
processing area & comfort
rooms
Sinks provided with soap,
nail brush & clean towels
Facilities for washing &
disinfecting equipment
Facilities
Lighting
Source: fluorescent light with no
glare & shadow
Provided with a cover
Adequate
Required in food preparation
area, warewashing area,
handwashing stations,
restrooms
Facilities
Floors
Concrete, kept clean regularly,
free of debris, & properly
drained
Durable & water resistant
No cracks, depression, or low
areas
Drains & gutters carefully
planned & located
Facilities
Walls & Ceilings
Impervious to moisture, easily
cleanable, smooth & light
colored
Walls can be tiles, cement
blocks, bricks, concretes &
metals
Roof is simple, watertight,
sufficiently high, & adequately
vented
Coving between walls, walls &
Facilities
Doors
Wide
Open outward
Made of corrosion-resistant or
suitable metal with adequate
impact strength
Self-closing
With air screen or plastic curtain
Facilities
Ventilation
Remove obnoxious odors, heat,
& moisture from the plant
Introduce fresh air, free of any
foreign odors & product
contaminants
Provide a comfortable
environment for the employees
Exhaust fan made of rustproofcoated steel
Facilities
Water Supply
Sufficient for operations from
adequate source
Safe & sanitary quality
Suitable temperature
Under pressure as needed
Supplied by a reputable source
Facilities
Waste Disposal
System
Must meet regulatory
requirements
Must not cause pollution
problems or create breeding
places for pests
Sewage system is connected to
the public sewerage system
cGMP
FACILITIES
HACCP
SSOP
PREMISES
cont
Premises
area where the plant
is located and its
Includes programs for
surroundings
the following:
cleaning and
sanitation
maintenance and
repair
pest control
Premises
maintained such that
food is kept from
adulteration and
contamination
should also consider
security and safety
Premises
Other considerations
- no domestic animals
- free from garbage/
waste
cGMP
FACILITIES
HACCP
PREMISES
SSOP
PRODUCTION
EQUIPMENT
cont
Production
Equipment
The primary objective is to
prevent adulteration and
contamination of raw materials
and food products with
lubricants, fuel, fragments or
any other foreign matter.
Production
constructed & installed in compliance with
Equipment
sanitary principles
Made of stainless steel/plastic and foodgrade
Made of impervious corrosion-resistant, easily
cleanable, resistant to chipping, & durable
material
Smooth seams on food-contact surfaces
Production
installed & kept in manner that supports
Equipment
preventive maintenance;
Production
EXAMPLE OF BAD TANK
DESIGN
Equipment
Production
EXAMPLES OF GOOD Equipment
TANK DESIGN
Production
CORRECT ARRANGEMENTS
OF
Equipment
VATS & TANKS
cGMP
FACILITIES
HACCP
PREMISES
SSOP
PRODUCTION
EQUIPMENT
INGREDIENTS
AND
RAW MATERIALS
Certificate of Analysis
Documents provided
by the supplier to a
client receiving a
product based on
compliance to a set
of specifications
agreed upon
FCC Products,Inc.
106 Naylon Avenue
Livingston, NJ 07039
CERTIFICATE OF ANALYSIS
To:
Lot No:
Quantity:
Product: Apple Cider Vinegar
DESCRIPTION: A composition made from maltro-dextrin, distilled vinegar, and natural flavor. The vinegar
is truly entrapped in a non-hygroscopic matrix.
LABEL DECLARATION: Malto-dextrin, Distilled Vinegar and Natural Cider Flavor.
SPECIFICATIONS: All components of this flavor are approved for use in foods by the
Food & Drug Administration.
Moisture.. Less Than 5%
Particle Size..100% through 16 mesh
Acidity.. Less Than 5% as Acetic Acid
Manufacturing Date:
Expiration Date: 18 Months from Manufacturing Date
This product has not been ETO treated.
To the best of our knowledge, this product is not GMO.
Letter of Guarantee
Document stating that
the material has been
processed in a way
that the buyers
specifications are
met
cGMP
FACILITIES
HACCP
PREMISES
SSOP
EQUIPMENT
PERSONAL HYGIENE
INGREDIENTS
AND
MATERIALS
Personal Hygiene
Are sanitary health habits that
include keeping the body, hair, &
teeth clean; wearing clean
clothes; & washing hands
properly.
Personal Hygiene
proof of good health
(medical and dental
certificates)
health questionnaire &
reporting agreement
regular training of
personnel
procedures on handling
personnel with illness
first aid kit accessible
Personal Hygiene
daily bath and other hygienic
practices
complete and clean uniform
use of gloves, hairnet and
face mask for food handlers
frequent hand washing
Personal Hygiene
Pathogenic microorganisms transmitted
through food handling
Hepatitis A virus
Norwalk & Norwalk-like viruses
Salmonella spp.
Shigella spp.
Staphylococcus aureus
Streptococcus pyrogenes
Escherichia coli O157:H7
Personal Hygiene
General Guidelines
A. Protective Clothing
Suitable, company issued protective clothing
shall be worn in food production or storage
areas
B. Laundry
Protective clothing should be laundered
regularly & effectively
Adequate changes of protective should be
available
Storage of clean protective clothing should be
available
Clean & soiled protective clothing should have
separate storage bins
Personal Hygiene
General Guidelines
C. Staff Change Facilities
Personal lockers should be available
Clean or soiled protective clothing should not
be stored in lockers
Periodic checking for compliance of locker
should be done
D. Protective Hair Covering
Disposable (if possible)
Worn by all in production or storage areas
Beards should also be covered
Personal Hygiene
General Guidelines
E. Personal Hygiene
Wash hands prior to entering food production
or storage areas and in between food handling
Fingernails should be kept short, clean &
unvarnished
Gloves should be suitable, disposable,
changed frequently & their disposal controlled
to avoid product contamination
Cuts & grazes should be covered with
waterproof plasters
F. Jewelry
Observe company rules on jewelry while
in food production areas
Personal Hygiene
General Guidelines
G. Eating, Smoking & Drinking
Strictly restricted to designated areas
Must be followed by proper hand-washing
H. Health Screening
All staff who will be entering food production,
storage & packing areas should complete a
Company Health Questionnaire
NO
Personal Hygiene
Managements Responsibility
cont
Personal Hygiene
Managements Responsibility
cont
Personal Hygiene
Managements Responsibility
Personal
Hygiene
cont
cGMP
FACILITIES
CHEMICAL
CONTROL
HACCP
PREMISES
SSOP
EQUIPMENT
PERSONAL
HYGIENE
INGREDIENTS
AND
RAW MATERIALS
Chemical Control
Follow appropriate
segregation, labeling,
use & storage
procedures of food &
non-food chemicals
cGMP
FACILITIES
CHEMICAL
CONTROL
HACCP
PREMISES
SSOP
EQUIPMENT
PERSONAL
HYGIENE
INGREDIENTS
AND
RAW MATERIALS
CLEANLINESS
AND
SANITATION
Cleanliness and
Sanitation
Effective management
of sanitation
programs includes education,
participation & proper delegation of
responsibilities among employees
Written detailed plans, procedures,
schedules & checklists regarding
cleaning & sanitizing of food & non-food
processing equipment & facilities
Evaluation of existing cleaning
procedures
Detailed program of control for storage
& use of cleaning & sanitizing chemicals
Cleanliness and
Sanitation
FOOD PLANT SANITATION IS EVERYONES
CONCERN!
TOP
MGT.
MIDDLE
MANAGEMENT
Cleanliness and
Sanitation
SANITATION COMMITTEE
Sanitation
Manager
Plant
Manager
QA
Manager
HRD
Manager
Production
Manager
Safety
Manager
cGMP
FACILITIES
CHEMICAL
CONTROL
HACCP
PREMISES
SSOP
EQUIPMENT
PERSONAL
HYGIENE
INGREDIENTS
AND
RAW MATERIALS
CLEANLINESS
AND
SANITATION
WAREHOUSING
AND
DISTRIBUTION
cont
Warehousing and
Distribution
Act of depositing, storing,
organizing and stocking goods
Act of delivering to retail
outlets /markets as
ordered/needed.
cont
Warehousing and
Distribution
Lot Identification
cont
Warehousing and
Distribution
Lot Identification
Warehousing and
Distribution
Storage Principles
Warehousing and
Distribution
Storage Principles
cont
Warehousing and
Distribution
cont
Warehousing and
Distribution
cont
Warehousing and
Distribution
cGMP
FACILITIES
CHEMICAL
CONTROL
WAREHOUSING
AND
DISTRIBUTION
HACCP
PREMISES
SSOP
EQUIPMENT
PERSONAL
HYGIENE
INGREDIENTS
AND
RAW MATERIALS
CLEANLINESS
AND
SANITATION
TRACEABILITY
AND
RECALL
cont
Farmers markets/
Roadside stands
Consumers
Food service
Exports
Retailers
Intermediaries:
Wholesalers/brokers/
repackers/exporters/
importers
Imports
Shippers
Growers
Processors
Precautionary Hold
Product suspected of
adulteration/ contamination
restricted for use, held & labeled
pending confirmation of test
results, risk assessment, etc.
Complaint Source
Government Agency
Vendor
Customer
Consumer
Employee
Routine Lab Results
Other
Product Recall
Withdrawal
Distribution
Reversal
needed
Handle as appropriate
Product Recall/Hold/Withdrawal
Communication Flow Chart
Obtain
Batch Info
Lot Number
Container Label
Vendor/
Manufacturer
Distributor
Broker
Customer
Caterer
Health Hazard
Nature of the violation or defect
Evaluation
Parts of RNR
cGMP
FACILITIES
CHEMICAL
CONTROL
WAREHOUSING
AND
DISTRIBUTION
HACCP
PREMISES
SSOP
EQUIPMENT
PERSONAL
HYGIENE
TRACEABILITY
AND
RECALL
INGREDIENTS
AND
RAW MATERIALS
CLEANLINESS
AND
SANITATION
SUPPLIER
CONTROL
cont
Supplier Control
Are established measures that
determine whether suppliers
have effective GMP, HACCP or
food safety program in place.
Consistent monitoring or control
of suppliers HACCP
implementation will reduce or
prevent potential hazards that
could occur in the raw material
or ingredient.
cont
Supplier Control
Supplier Control
cont
Supplier Control
cont
Supplier Control
Examples of Questions to Ask:
What are the standards of sanitation used?
Does the supply company follow approved
practices in handling products?
If it handles refrigerated or frozen
products, is it equipped to do the job?
Is there enough warehouse space?
Are delivery trucks adequately
refrigerated?
cont
Supplier Control
Are employees cooperative and
are they trained in sanitary
practices?
Is the supplier willing to make
deliveries when the personnel are
not rushed so that food can be
handled quickly and properly?
cont
cGMP
FACILITIES
CHEMICAL
CONTROL
WAREHOUSING
AND
DISTRIBUTION
HACCP
PREMISES
SSOP
EQUIPMENT
PERSONAL
HYGIENE
TRACEABILITY
AND
RECALL
SUPPLIER
CONTROL
INGREDIENTS
AND
RAW MATERIALS
CLEANLINESS
AND
SANITATION
PEST CONTROL
cont
Pest Control
Effective measures that prevent the entry &
proliferation of pests from receiving,
processing, packaging & storage areas
Establishments & surrounding areas
regularly examined for infestation
Continuous application through effective
sanitation & use of chemicals
Pest Control
Examples of Pest Control Program
Double-screened windows &
doors
Self-closing door
Elimination of cracks in floors &
walls
Double-screened gutter drains
Placing garbage cans outside the
plant & far from the processing
area
Pest Control
Examples of Pest Control Program
Covered food storage
Food storage 6 inches above the floor & from
the wall
Cleaning spills immediately
Use of hanging flypapers & glue traps
With the aid of a pest control company
MANAGING PREREQUISITE
PROGRAMS
Documentation
Training
Verification
Activities
MANAGING PREREQUISITE
PROGRAMS
Documentation
Written guidelines &
procedures
Records of previously
encountered
problems & solutions
that were
implemented
MANAGING PREREQUISITE
PROGRAMS
Training
Periodic
Well-designed
Will cater to all level of
employees
MANAGING PREREQUISITE
PROGRAMS
Verification Activities
Routines performed by
supervisors that guarantee the
implementation of corrective
actions & that programs are
functioning as intended
PREREQUISITE PROGRAM
ASSESSMENT
Check existence & effectiveness
during design & implementation of
HACCP plan
Document & regularly audit progress
Aspect that may be incorporated into
HACCP plan