GMP-SSOP

HACCP
cGMP SSOP
INGREDIENTS
FACILITIES PREMISES EQUIPMENT AND
RAW MATERIALS
CLEANLINESS
CHEMICAL PERSONAL
AND
CONTROL HYGIENE
SANITATION
WAREHOUSING TRACEABILITY
SUPPLIER
AND AND PEST CONTROL
CONTROL
DISTRIBUTION RECALL

•cont
GOOD MANUFACTURING PRACTICES

 sets of principles
on controls,
conditions for quality
and hygienic
handling/processing/
service of foods
SANITATION STANDARD OPERATING
PROCEDURES

 establishment-specific
sanitation and hygienic
procedures and practices
 interpretation and
implementation of GMP
by establishment
 HACCP
cGMP SSOP

FACILITIES
 Facilities
 building
 sanitary facilities
 lighting
 floors, walls, ceilings, doors
 ventilation
 water supply
 waste disposal system
 Facilities

Things to consider:
- design Includes programs for the
- materials following:

- construction  cleaning and sanitation

- layout  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 With the following areas:
basis - rest & dining areas
• Lay-out follows a straight-
line process flow - locker rooms
- landscape garden/trees
- comfort rooms
- medical clinic
 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
factory layout Laboratory Administration
with all
departments
housed within a
single
compound
Production Area EA

Raw
Raw Material Storage FPS
materials

EA = Employee amenities
Final
FPS = Finished Products Storage products
 GOOD MANUFACTURING PRACTICES
Raw
materials

Alternative
arrangements Raw Material Storage
of
departments Main
entrance A
under a single
compound Production Area

A = Administration
L = Laboratory L
Finished Product Storage
EA = Employee EA
amenities
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 & floors
& walls & ceilings should be sealed
 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 rustproof-
coated 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
 HACCP
cGMP SSOP

FACILITIES 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
- free from pollution and dirt odors, smokes, dust &
other contaminants
- no flooding
- no weeds or grass
- concrete roads & parking
space
 HACCP
cGMP SSOP
PRODUCTION
FACILITIES PREMISES
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 Equipment
 constructed & installed in compliance with sanitary
principles
 Made of stainless steel/plastic and food-grade
 Made of impervious corrosion-resistant, easily
cleanable, resistant to chipping, & durable
material
 Smooth seams on food-contact surfaces
 Production Equipment
 installed & kept in manner that supports
 preventive maintenance;
 replacement of malfunctioning parts;
 calibration; and
 cleaning schedules
 Production Equipment
EXAMPLE OF BAD TANK DESIGN

Products cannot be drained

 Production Equipment
EXAMPLES OF GOOD TANK DESIGN
 Production Equipment
CORRECT ARRANGEMENTS OF VATS
& TANKS

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

floor debris is apt to accumulate beneath it.
 HACCP
cGMP SSOP
INGREDIENTS
PRODUCTION
FACILITIES PREMISES AND
EQUIPMENT
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 buyer’s
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.
 HACCP
cGMP SSOP
INGREDIENTS
FACILITIES PREMISES EQUIPMENT AND
MATERIALS

PERSONAL HYGIENE
 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 NO

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?
 Personal Hygiene
Management’s Responsibility
• Develop job assignments
• Provide adequate facilities
• Lead by example
• Provide ongoing supervision and training

•cont
 Personal Hygiene
Management’s 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
Management’s 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
 HACCP
cGMP SSOP
INGREDIENTS
FACILITIES PREMISES EQUIPMENT AND
RAW MATERIALS
CHEMICAL PERSONAL
CONTROL HYGIENE
 Chemical Control
• Follow appropriate
segregation, labeling,
use & storage
procedures of food &
non-food chemicals
 HACCP
cGMP SSOP
INGREDIENTS
FACILITIES PREMISES EQUIPMENT AND
RAW MATERIALS
CLEANLINESS
CHEMICAL PERSONAL
AND
CONTROL HYGIENE
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 EVERYONE’S
CONCERN!

TOP
MGT.

MIDDLE
MANAGEMENT

SHOP FLOOR WORKERS

 Cleanliness and Sanitation
SANITATION COMMITTEE

Sanitation Plant
Manager Manager

HRD
QA
Manager
Manager
Safety
Production
Manager
Manager
 HACCP
cGMP SSOP
INGREDIENTS
FACILITIES PREMISES EQUIPMENT AND
RAW MATERIALS
CLEANLINESS
CHEMICAL PERSONAL
AND
CONTROL HYGIENE
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
(40˚F - 140˚F or 4.4˚C - 60˚C).
• 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
 HACCP
cGMP SSOP
INGREDIENTS
FACILITIES PREMISES EQUIPMENT AND
RAW MATERIALS
CLEANLINESS
CHEMICAL PERSONAL
AND
CONTROL HYGIENE
SANITATION
WAREHOUSING TRACEABILITY
AND AND
DISTRIBUTION 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 high-value
products
• Larger net revenues
Farmer’s markets/
Consumers
Roadside stands

Food service Retailers

Intermediaries:
Wholesalers/brokers/
Exports Imports
repackers/exporters/
importers

Shippers

Growers Processors

Tracing fresh produce through the food marketing system

 Traceability and Recall

RECALL
- It is a firm’s 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/
Vendor Product Recall
Obtain Manufacturer
Customer Withdrawal Y Batch Info Distributor
Consumer Distribution
Lot Number Broker
Employee Reversal
Container Label Customer
Routine Lab Results needed
Caterer
Other

N
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
Handle as appropriate 4. Reasons for recall/ withdrawal
5. Manufacturing location
6. Location of distribution
7. Number of cases sent to locations
8. What is its brand
Product Recall/Hold/Withdrawal 9. What to do with products
Communication Flow Chart 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. Consumer level (consumer)
2. Retail level (retail stores)
3. User level (hotel, restaurants)
4. Wholesale level (between manufacturer & retailer)
Health Hazard Evaluation
• Nature of the violation or defect
• 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)
 HACCP
cGMP SSOP
INGREDIENTS
FACILITIES PREMISES EQUIPMENT AND
RAW MATERIALS
CLEANLINESS
CHEMICAL PERSONAL
AND
CONTROL HYGIENE
SANITATION
WAREHOUSING TRACEABILITY
SUPPLIER
AND AND
CONTROL
DISTRIBUTION RECALL

•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
supplier’s 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 supplier’s
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?
• Are the products packaged safely? •cont
 HACCP
cGMP SSOP
INGREDIENTS
FACILITIES PREMISES EQUIPMENT AND
RAW MATERIALS
CLEANLINESS
CHEMICAL PERSONAL
AND
CONTROL HYGIENE
SANITATION
WAREHOUSING TRACEABILITY
SUPPLIER
AND AND PEST CONTROL
CONTROL
DISTRIBUTION RECALL

•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