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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

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GOOD MANUFACTURING PRACTICES

 sets of
principles on
controls,
conditions for
quality and
hygienic
handling/processi
ng/ 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
- materials the 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 With the following
• cleaned on a regular areas:
basis - rest & dining areas
• Lay-out follows a
straight-line process - locker rooms
flow - 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
factory layout Laboratory Administration
with all
departments
housed within a
single
Production Area EA
compound

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 &
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

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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 • location & size must
security and safety support & facilitate
maintenance & sanitary
operations
Premises
Other considerations…
- no domestic animals
- free from garbage/ - free from objectionable
waste odors, smokes, dust &
- free from pollution and other contaminants
dirt - no weeds or grass
- no flooding - concrete roads &
parking space
HACCP
cGMP SSOP
PRODUCTION
FACILITIES PREMISES
EQUIPMENT

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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
EXAMPLE OF BAD Equipment
TANK
DESIGN

Products cannot be drained


Production
EXAMPLES OF Equipment
GOOD TANK
DESIGN
Production
CORRECT Equipment
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
 Store properly Materials
 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
G. 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

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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?

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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

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…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…”

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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

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Warehousing and
Distribution

• Act of depositing, storing,


organizing and stocking goods
• Act of delivering to retail
outlets /markets as
ordered/needed.

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…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

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…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

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…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

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…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

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…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.

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…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

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

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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
4. Reasons for recall/ withdrawal
Handle as appropriate
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 Chart10. 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

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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.
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…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
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…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

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…Supplier Control

…Types of Supplier Control used by


firms

8. Vendor audits performed by third parties.


9. Documentation of problems with
supplier’s products

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…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? •co
…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?
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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

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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