GOOD MANUFACTURING PROCESS

1. GMP-SSOP

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

3.  sets of principles
on controls,
conditions for quality
and hygienic
handling/processing/
service of foods
GOOD MANUFACTURING PRACTICES

4.  establishment-specific
sanitation and hygienic
procedures and practices
 interpretation and
implementation of GMP
by establishment
SANITATION STANDARD OPERATING
PROCEDURES

5. cGMP SSOP
HACCP
FACILITIES

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

7. Things to consider:
- design
- materials
- construction
- layout
Includes programs for the
following:
 cleaning and sanitation
 maintenance and repair
 pest control
Facilities

8. Building
Must be designed & constructed to ensure:
- hygienic food handling
- effective cleaning & sanitation
- prevention of entry of pests
- safety of personnel
Facilities

9. With the following areas:
- rest & dining areas
- locker rooms
- landscape garden/trees
- comfort rooms
- medical clinic
Building
• Location, construction,
maintenance according to
sanitary design principles
• cleaned on a regular
basis
• Lay-out follows a straight-
line process flow
Facilities

10. Building
Areas of a Plant:
• Receiving area
• Ingredient storage area
• Processing area
• Finished product
warehousing area
• Toilet area
Plant Lay-out
Facilities

11. A simple
factory layout
with all
departments
housed within a
single
compound
Administration
Laboratory
Production Area EA
Raw Material Storage FPS
Main entrance
EA = Employee amenities
FPS = Finished Products Storage
Raw
materials
Final
products
Facilities

12. Alternative
arrangements
of
departments
under a single
compound
A
L
Production Area
EA
GOOD MANUFACTURING PRACTICES
Raw Material Storage
Finished Product Storage
Main
entrance
A = Administration
L = Laboratory
EA = Employee
amenities
Raw
materials
Final
products

13. 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

14. Lighting
• Source: fluorescent light with no
glare & shadow
• Provided with a cover
• Adequate
• Required in food preparation area,
warewashing area, handwashing
stations, restrooms
Facilities

15. 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

16. 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

17. Doors
• Wide
• Open outward
• Made of corrosion-resistant or
suitable metal with adequate impact
strength
• Self-closing
• With air screen or plastic curtain
Facilities

18. 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

19. Water Supply
• Sufficient for operations from
adequate source
• Safe & sanitary quality
• Suitable temperature
• Under pressure as needed
• Supplied by a reputable source
Facilities

20. 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
Facilities

21. cGMP SSOP
HACCP
FACILITIES PREMISES
•cont

22. • area where the plant is
located and its
surroundings
Includes programs for
the following:
 cleaning and
sanitation
 maintenance and
repair
 pest control
Premises

23. • 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

24. Other considerations…
- no domestic animals
- free from garbage/ waste
- free from pollution and dirt
- no flooding
- free from objectionable
odors, smokes, dust &
other contaminants
- no weeds or grass
- concrete roads & parking
space
Premises

25. cGMP SSOP
HACCP
FACILITIES PREMISES
PRODUCTION
EQUIPMENT
•cont

26. 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.

27.  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

28.  installed & kept in manner that supports
 preventive maintenance;
 replacement of malfunctioning parts;
 calibration; and
 cleaning schedules
Production Equipment

29. EXAMPLE OF BAD TANK DESIGN
Products cannot be drained
Production Equipment

30. EXAMPLES OF GOOD TANK DESIGN
Production Equipment

31. CORRECT ARRANGEMENTS OF VATS
& TANKS
The tank on the left is difficult to clean around, hence
floor debris is apt to accumulate beneath it.
Production Equipment

32. cGMP SSOP
HACCP
FACILITIES PREMISES
PRODUCTION
EQUIPMENT
INGREDIENTS
AND
RAW MATERIALS

33.  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
Ingredients & Raw Materials

34. Documents provided
by the supplier to a
client receiving a
product based on
compliance to a set
of specifications
agreed upon
Certificate of Analysis

35. 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.

36. Document stating that
the material has been
processed in a way
that the buyer’s
specifications are
met
Letter of Guarantee

37.  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

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

39. cGMP SSOP
HACCP
FACILITIES PREMISES EQUIPMENT
INGREDIENTS
AND
MATERIALS
PERSONAL HYGIENE

40. Personal Hygiene
… Are sanitary health habits that
include keeping the body, hair, & teeth
clean; wearing clean clothes; &
washing hands properly.

41.  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

42.  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

43.  Hepatitis A virus
 Norwalk & Norwalk-like viruses
 Salmonella spp.
 Shigella spp.
 Staphylococcus aureus
 Streptococcus pyrogenes
 Escherichia coli O157:H7
Pathogenic microorganisms transmitted
through food handling
Personal Hygiene

44. 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
General Guidelines
Personal Hygiene

45. 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
General Guidelines
Personal Hygiene

46. 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
General Guidelines
Personal Hygiene

47. 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
General Guidelines
Personal Hygiene

48. 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?

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

50. 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

51. 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

52. “…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
…Personal Hygiene

53. cGMP SSOP
HACCP
FACILITIES PREMISES EQUIPMENT
INGREDIENTS
AND
RAW MATERIALS
CHEMICAL
CONTROL
PERSONAL
HYGIENE

54. • Follow appropriate
segregation, labeling,
use & storage
procedures of food &
non-food chemicals
Chemical Control

55. cGMP SSOP
HACCP
FACILITIES PREMISES EQUIPMENT
CLEANLINESS
AND
SANITATION
PERSONAL
HYGIENE
INGREDIENTS
AND
RAW MATERIALS
CHEMICAL
CONTROL

56.  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

57. FOOD PLANT SANITATION IS EVERYONE’S
CONCERN!
TOP
MGT.
MIDDLE
MANAGEMENT
SHOP FLOOR WORKERS
Cleanliness and Sanitation

58. SANITATION COMMITTEE
Sanitation
Manager
QA
Manager
Production
Manager
Plant
Manager
HRD
Manager
Safety
Manager
Cleanliness and Sanitation

59. cGMP SSOP
HACCP
FACILITIES PREMISES EQUIPMENT
INGREDIENTS
AND
RAW MATERIALS
CHEMICAL
CONTROL
PERSONAL
HYGIENE
WAREHOUSING
AND
DISTRIBUTION
CLEANLINESS
AND
SANITATION
•cont

60. Warehousing and Distribution
• Act of depositing, storing, organizing
and stocking goods
• Act of delivering to retail outlets
/markets as ordered/needed.
•cont

61. …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

62. …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

63. …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

64. …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

65. • 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

66. • 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

67. • 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
…Warehousing and Distribution

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

69. 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

70. • 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

71. Benefits:
• Lower cost of distribution
• Reduced recall expenses
• Expanded sales of high-value
products
• Larger net revenues
Traceability and Recall

72. Growers Processors
Imports
Shippers
Intermediaries:
Wholesalers/brokers/
repackers/exporters/
importers
Retailers
Farmer’s markets/
Roadside stands
Consumers
Exports
Food service
Tracing fresh produce through the food marketing system

73. 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

74. 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

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

76. a Successful Recall Process
• Planning ahead
• Acting quickly
• Effective communication during a recall
• Recall assessment

77. • Used when a minor violation is
not subject to legal action
Market withdrawal
Precautionary Hold
• Product suspected of adulteration/
contamination restricted for use, held
& labeled pending confirmation of
test results, risk assessment, etc.
Traceability and Recall

78. Complaint Source
Government Agency
Vendor
Customer
Consumer
Employee
Routine Lab Results
Other
Product Recall
Withdrawal
Distribution
Reversal
needed
Obtain
Batch Info
Lot Number
Container Label
Y
Vendor/
Manufacturer
Distributor
Broker
Customer
Caterer
Handle as appropriate
Product Recall/Hold/Withdrawal
Communication Flow Chart
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
N

79. • 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
Recall Classifications
Traceability and Recall

80. 1. Consumer level (consumer)
2. Retail level (retail stores)
3. User level (hotel, restaurants)
4. Wholesale level (between manufacturer & retailer)
Depth of Recall
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

81. • 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
Recall Notice Report (RNR)
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

82. Recall Notice Report (RNR)
Traceability and Recall

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

84. 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

85. …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

86. …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

87. …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

88. 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

89. • 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
…Supplier Control

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

91.  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

92.  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

93.  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
Pest Control

94. MANAGING PREREQUISITE PROGRAMS
Documentation
Training
Verification Activities

95. MANAGING PREREQUISITE PROGRAMS
 Documentation
 Written guidelines &
procedures
 Records of previously
encountered problems &
solutions that were
implemented

96. MANAGING PREREQUISITE PROGRAMS
 Training
 Periodic
 Well-designed
 Will cater to all level of employees

97. MANAGING PREREQUISITE PROGRAMS
 Verification Activities
 Routines performed by supervisors
that guarantee the implementation
of corrective actions & that
programs are functioning as
intended

98. PREREQUISITE PROGRAM ASSESSMENT
 Check existence & effectiveness during
design & implementation of HACCP plan
 Document & regularly audit progress
 Aspect that may be incorporated into
HACCP plan