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GMP-SSOP

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

GOOD MANUFACTURING PRACTICES

sets of
principles on
controls,
conditions for
quality and
hygienic
handling/processi
ng/ service of
foods

SANITATION STANDARD OPERATING


PROCEDURES
establishmentspecific sanitation
and hygienic
procedures and
practices
interpretation and
implementation of
GMP by
establishment

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

Includes programs for


the following:
cleaning and
sanitation
maintenance and
repair
pest control

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

With the following


areas:
- rest & dining areas
- locker rooms
- landscape
garden/trees
- comfort rooms

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

Raw Material Storage

EA = Employee amenities
FPS = Finished Products Storage

EA

FPS

Final
products

GOOD MANUFACTURING PRACTICES


Raw
materials
Alternative
arrangements
of
departments
under a single
compound

Raw Material Storage


Main
entrance

A
Production Area

A = Administration
L = Laboratory
EA = Employee
amenities

L
EA

Finished Product Storage

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

location & size must


support & facilitate
maintenance & sanitary
operations

Premises
Other considerations
- no domestic animals
- free from garbage/
waste

- free from objectionable


odors, smokes, dust &
other contaminants
- free from pollution and
dirt
- no weeds or grass
- no flooding

- concrete roads &


parking space

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;

replacement of malfunctioning parts;


calibration; and
cleaning schedules

Production
EXAMPLE OF BAD TANK
DESIGN
Equipment

Products cannot be drained

Production
EXAMPLES OF GOOD Equipment
TANK DESIGN

Production
CORRECT ARRANGEMENTS
OF
Equipment
VATS & TANKS

The tank on the left is difficult to clean around, hence


floor debris is apt to accumulate beneath it.

cGMP
FACILITIES

HACCP

PREMISES

SSOP

PRODUCTION
EQUIPMENT

INGREDIENTS
AND
RAW MATERIALS

Ingredients & Raw


Materials
Should be received, stored, handled
&
transported under specific sanitary &
environmental conditions
Have Certificate of Analysis (COA) or Letter of
Guarantee (LOG)
May be based on international standards &
publications based on scientific research
Should include sampling procedures,
analytical methodology & limits for
acceptance

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

Ingredients & Raw


Materials
Inspected as soon as it is issued
from the
stockroom

Do sensory & chemical analysis


Canned raw material should be analyzed
according to quantity, expiry date, and presence
of dents, bulges, punctures, and leakage
Fresh raw material should be analyzed based on
weight, presence of soil particles, bruises,
discoloration
Results of inspection should be recorded in a
Raw Material Inspection Form
Return non-conforming raw materials to supplier

Ingredients & Raw


Materials
Store properly
Follow FIFO
When in doubt,
throw it out!
Never put raw food
over prepared food.

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

PERSONNEL INSPECTION CHECKLIST


YES
Are workers with communicable illnesses prohibited from working
with food products?
Are uniforms frocks clean & neat?
Do workers was their hands after using the restroom?
Do workers wash their hands before returning to work & after
eating breaks?
Are workers informed of proper handwashing procedures?
Do workers remove their jewelry or personal effects while
working?
Do workers pay attention to personal hygiene?
Do policies prohibit eating, drinking or smoking in the processing
area?
Are routine training programs held?

NO

Personal Hygiene
Managements Responsibility

Develop job assignments


Provide adequate facilities
Lead by example
Provide ongoing supervision and training

cont

Personal Hygiene
Managements Responsibility

To evaluate employee training program,


ask these questions:
Did the training produced results on the job?
If intended results ere not produced, why not?

cont

Personal Hygiene
Managements Responsibility

Hiring the right employees


Using task analysis to determine the food safety
and sanitation requirements for each job
Establishing employee rules
for personal hygiene
Supervising and training employees
in good personal hygiene and
food safety practices
cont

Personal
Hygiene

in any type of processing


operation, the primary consideration
in food safety is PEOPLE. The
effectiveness of any food safety
program heavily depends on the
attitude, willingness and effort of
people to follow personal hygiene
practices

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

SHOP FLOOR WORKERS

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

Lot a definitive quantity of a


commodity produced under
essentially the same conditions
Each container should be embossed
or permanently marked in code or in
clear to identify producing factory
and lot

cont

Warehousing and
Distribution
Lot Identification

Permanent, legible and dated records


and pertinent processing details
should be kept for a period exceeding
the shelf-life of the product but not
exceeding two years
Records regarding initial distribution of
the lot should be kept
Necessary for warehousing
cont

Warehousing and
Distribution
Storage Principles

First-in-First-Out (FIFO) System


should be implemented.
Goods should be used in the order in
which they are delivered
Create a system, such as dating
goods on receipt and placing new
deliveries behind those already in
storage to
guarantee that FIFO is
followed
cont

Warehousing and
Distribution
Storage Principles

Keep potentially hazardous foods out


of the temperature danger zone
(40F - 140F or 4.4C - 60C).
Store food products and raw
materials separately only in
designated areas for storage in order
to eliminate the risk of contamination

cont

Warehousing and
Distribution

Keep all goods in clean, undamaged


wrappers or packages
Elimination/ minimizing
contamination of goods during
storage
Periodic inspection of product during
storage.

cont

Warehousing and
Distribution

Keep storage areas clean and dry


this rule applies to dry storage,
refrigerators, freezers, and heated
cabinets
Keep vehicles for transporting food
clean

cont

Warehousing and
Distribution

Finished products should be stored and


transported under conditions that will
protect against contamination,
deterioration of the product and damage
to the container
Periodic inspection of products during
storage should be done
Products should be dispatched
following a specific sequence
cont

cGMP
FACILITIES
CHEMICAL
CONTROL
WAREHOUSING
AND
DISTRIBUTION

HACCP

PREMISES

SSOP

EQUIPMENT

PERSONAL
HYGIENE

INGREDIENTS
AND
RAW MATERIALS
CLEANLINESS
AND
SANITATION

TRACEABILITY
AND
RECALL
cont

Traceability and Recall


System which
implements proper
coding or labeling of
raw materials and
finished products in
the anticipation of
circumstances which
will require complete
traces of product
retrievals

Traceability and Recall


All raw materials and products should be
lot-coded and recall system in place so
that rapid and complete traces and recalls
can be done

Traceability and Recall


Benefits:
Lower cost of distribution
Reduced recall expenses
Expanded sales of highvalue products
Larger net revenues

Farmers markets/
Roadside stands

Consumers

Food service

Exports

Retailers
Intermediaries:
Wholesalers/brokers/
repackers/exporters/
importers

Imports

Shippers

Growers

Processors

Tracing fresh produce through the food marketing system

Traceability and Recall


RECALL
- It is a firms voluntary removal of product
from trade or consumer channels (e.g.
importers or manufacturers) to protect the
public from consuming adulterated or
misbranded products

Traceability and Recall


RECALL
any corrective action by a company
needed to protect consumers from
potentially adverse effects of a
contaminated, adulterated, or
misbranded product

Traceability and Recall


RECALL
- It may be an alternative detention or
seizure of adulterated or misbranded
product
- Does not include a market withdrawal or
stock recovery

a Successful Recall Process


Planning ahead
Acting quickly
Effective communication during a
recall
Recall assessment

Traceability and Recall


Market withdrawal
Used when a minor violation
is not subject to legal action

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

Formally notify customers thru mail or phone call:


1. Product number/ volume produced
2. Batch number, lot number, production date,
spec number
3. Container label
4. Reasons for recall/ withdrawal
5. Manufacturing location
6. Location of distribution
7. Number of cases sent to locations
8. What is its brand
9. What to do with products
10. Notify authorities as appropriate

Traceability and Recall


Recall
Classifications
Class 1 health hazard situation where there is a
reasonable probability that use of the product will
cause serious adverse health consequences or
death
ex. E. coli O157:H7 in ground beef
Class 2 health hazard situation where there is a
remote probability that use of the product will
cause adverse health consequences
ex. Histamine (undeclared)
Class 3 health hazard situation where the use of
the product will not cause adverse health
consequences
ex. GRAS (undeclared), excess water

Traceability and Recall


Depth of Recall
1.
2.
3.
4.

Consumer level (consumer)


Retail level (retail stores)
User level (hotel, restaurants)
Wholesale level (between manufacturer & retailer)

Health Hazard
Nature of the violation or defect
Evaluation

Occurrence of illnesses or injuries


Likelihood that illnesses may result
Type of illnesses or injuries that may result
Procedure to determine the need for a recall

Traceability and Recall


Recall Notice Report
(RNR)
Provide consumers & public health community
with information related to product in question
Posted in Regulation Agency Recall website
Electronically distributed to public health &
inspection program officials throughout the
country with the date & recall case numbers

Parts of RNR

Specific product recalled with identifying codes


Name of recalling firm, contact person & phone
nos.
Quantity of product recalled
Reason for recall, how & when it was discovered

Traceability and Recall


Recall Notice Report
(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

Types of Supplier Control used by firms:


1. Receipt of raw materials only from known
sources of supply
2. HACCP Plan required for classification as
certified suppliers.
3. Inspection of ingredients and shipping
containers for evidence of unsanitary
conditions.
4. Shipping containers should include
record of prior use and cleaning
cont

Supplier Control

Types of Supplier Control used by


firms
5. In-house lab analysis and random sampling.
6. Quick tests of indicator parameters
used to assess acceptability of raw materials.
7. Screening of new vendors which includes initial
sample analysis by outside laboratory and
random sampling for 6 months

cont

Supplier Control

Types of Supplier Control used by


firms
8. Vendor audits performed by third parties.
9. Documentation of problems with
suppliers products

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?

Are minimal bacterial requirements


for specific products met?
Is the product quality consistent?

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