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PART II GOOD MANUFACTURING PRACTICES (GMP)

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PART II GOOD MANUFACTURING PRACTICES (GMP) GMP Prerequisite programs which will provide the basic environmental and operating conditions that are necessary for the ... – PowerPoint PPT presentation

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Title: PART II GOOD MANUFACTURING PRACTICES (GMP)


1
PART II GOOD MANUFACTURING PRACTICES (GMP)
2
GMP
  • Prerequisite programs which will provide the
    basic environmental and operating conditions that
    are necessary for the production of safe and
    wholesome food.

3
SSOP Sanitation Standard Operating Procedures
4
According to FDA, the SSOP should include
  • General maintenance
  • Substances used in cleaning and sanitizing
  • storage of toxic materials
  • Pest control
  • Sanitation of food-contact surfaces
  • Storage and handling of clean portable
    equipment and utensils
  • Rubbish disposal

5
  • The SSOP adopted by FSIS cover the
    pre-operational and operational sanitation
    procedures that an establishment shall implement
    to prevent direct contamination or adulteration
    of products

6
FOOD SAFETY ON PRIMARY PRODUCTION
7
  • DEFINITION
  • Covers all steps of the food chain, from
    production to harvest, slaughter, milking or
    fishery

8
  • OBJECTIVE
  • Ensures that food is safe and suitable for its
    intended use

9
  • CHALLENGE
  • The integration of government agencies with
    primary producers.

10
IMPORTANT ASPECTS
  • ENVIRONMENTAL HYGIENE
  • Water
  • Land
  • HYGIENIC PRODUCTION OF FOOD
  • HANDLING, STORAGE AND TRANSPORTATION
  • CLEANING, MAINTENANCE AND PERSONNEL HYGIENE

11
  • ENVIRONMENTAL HYGIENE
  • Water irrigation, application of pesticides
    and fertilizers, cooling, frost control,
    drinking water, cleaning of buildings, personal
    hygiene, etc
  • Has the potential to be a direct source of
    contamination and a vehicle for spreading
    contamination
  • Irrigation water source and supply

12
  • HYGIENIC PRODUCTION OF FOOD
  • Control contamination from air, soil, water,
    foodstuffs, fertilizers (including natural
    fertilizers), pesticides, veterinary drugs or any
    other agent used in primary production
  • Control plant and animal health so that it does
    not pose a threat to human health through food
    consumption, or adversely affect the suitability
    of the product

13
  • Protect food from fecal and other
    contamination
  • Manage wastes, and store harmful substances
    appropriately.

14
  • HANDLING, STORAGE AND TRANSPORTATION
  • Procedures should be in place to
  • Sort out food and food ingredients from material
    which is clearly unfit for human consumption
  • Dispose of any rejected material in a hygienic
    manner and

15
  • Protect food and food ingredients from
    contamination by pests, chemical, physical or
    microbial contaminants or other objectionable
    substances during handling, storage and
    transportation.

16
CLEANING, MAINTENANCE AND PERSONNEL HYGIENE
  • Appropriate facilities and cleaning procedures

17
  • ESTABLISHMENT DESIGN AND FACILITIES

18
  • OBJECTIVES
  • - Minimize contamination
  • - Permit appropriate maintenance, cleaning and
    sanitizing

19
BUILDING
  • Establishments should be built away from
  • ? Polluted areas and industrial activities which
    pose a threat for contamination of food
  • Areas subject to floods, unless sufficient
    safeguards are provided
  • areas prone to infestations by pests
  • ? Areas where waste (solid or liquid) cannot be
    removed effectively.

20
  • MAINTENANCE
  • Maintain roads, yards, and parking to avoid
    contamination of areas where food is exposed
  • Adequately drain areas that may contribute to
    contamination of food by foodborne filth, or
    provide conditions for nesting and breeding of
    for pests
  • Operate systems for waste treatment and disposal
    in an adequate manner.

21
  • PREMISES AND WORKING AREAS
  • Design and layout
  • protect against cross-contamination
  • control process flow

22
  • Internal structures and fittings
  • Walls and floors
  • Ceilings and overhead fixtures
  • Windows
  • Doors
  • Working surfaces
  • Establishments
  • Sewage lines.

23
  • EQUIPMENT
  • Sanitation and maintenance to avoid
    contamination
  • Construction material
  • Durability
  • Maintenance, Sanitation, Monitoring

24
  • Program of preventive maintenance
  • List of equipment requiring regular maintenance.
  • Procedures and frequencies of maintenance are
    based on instructions from the manufacturers or
    on operating conditions.

25
  • FACILITIES
  • Water supply
  • Drainage and waste disposal
  • Cleaning
  • Facilities for personnel hygiene
  • Toilets
  • Temperature control
  • Air quality and ventilation
  • Lighting
  • Storage

26
CONTROL OF OPERATIONS
27
  • Objectives
  • Production of safe and suitable food for human
    consumption ensuring
  • requirements for raw materials, composition,
    processing, distribution, and consumer use
  • designing, implementing, monitoring and
    reviewing control systems.

28
Control of Food Hazards
29
  • identify any points in the operations which are
    critical to the safety of food
  • implement effective control procedures
  • ensure effectiveness of procedures
  • review procedures periodically.

30
  • Examples of general procedures
  • Product composition
  • current written composition
  • details of formulation

31
  • Food additives
  • Manufacturer should guarantee that all additives
    in use
  • are approved for the food being produced
  • comply with the specific laws and regulations
  • are pure
  • provide certifications for each lot
  • comply with legal limits.

32
  • Label accuracy
  • The manufacturer should ensure that the label
    provides
  • accurate information of net contents
  • manufacturers, packers and/or distributors
    names and addresses and
  • instructions for proper handling by the
    consumer

33
Time and temperature control
34
  • Time and temperature control
  • Such controls include time and temperature of
  • Cooking
  • Cooling
  • Processing
  • Storage

35
  • Temperature control systems should take into
    account
  • nature of the food
  • intended shelf-life of the product
  • method of packaging and processing
  • intended use

36
  • Specify limits for time and temperature
    variation
  • Calibration and verification of equipment and
    instruments

37
  • Metrologic verification
  • Set of operations needed to assure that a
    measuring equipment complies with standards and
    requirements for the intended use.

38
Specific process steps
39
  • chilling
  • thermal processing
  • irradiation
  • drying
  • chemical preservation
  • packaging in vacuum or modified atmospheer

40
Microbiological cross contamination
41
  • Pathogens can be transferred from one food to
    another, either by direct contact, by food
    handlers, through common contact with surfaces,
    or through the air.

42
Chemical and physical contamination
43
  • Contamination of food by foreign matters such as
    glass or metal particles, dust, harmful fumes and
    unwanted chemicals.

44
RAW MATERIAL AND INGREDIENTS
45
  • Reception
  • Manufacturer
  • Specifications
  • Chemicals
  • Inspection of raw material

46
PACKAGING
47
  • Packaging materials
  • Protection of food
  • Prevent recontamination

48
WATER
49
  • Water Quality
  • Chlorine
  • Analysis
  • Cleaning of reservoirs

50
  • Ice making
  • Steam production
  • Drainage
  • Plumbing

51
  • Aspects to be considered
  • adequate source
  • appropriate temperature and pressure
  • separated system according to use
  • allowed disinfecting agents
  • control of drinking water

52
  • Monitoring
  • Correcting deviations
  • Records
  • Water standards WHO

53
MANAGEMENT AND SUPERVISION
54
  • The type of control and supervision needed will
    depend on the size of the business, the nature
    of the activities and the types of food being
    produced.
  • Managers and supervisors should have enough
    knowledge of principles of food hygiene

55
DOCUMENTATION AND RECORDS
56
Monitoring time Legibility Revising and
updating records
57
RECALL PROCEDURES
58
  • Recall information should include the following
  • Amount of product produced, in inventory and
    distributed.
  • Name, size, code or lot numbers of food recalled
  • Area of distribution
  • Reason for the recall
  • Final disposition of the product (rework,
    discharge, etc.)

59
Storage
60
  • Temperature conditions
  • Relative humidity
  • Air velocity
  • FIFO (First In First Out)

61
BUILDINGMAINTENANCE AND SANITATION
62
  • OBJECTIVES
  • To establish effective systems to ensure
    appropriate maintenance and cleaning, pest
    control, waste management and effective
    monitoring.

63
  • Biofilm
  • Adhesion
  • Protection
  • Resistance

64
  • CLEANING PROCEDURES AND METHODS

65
Cleaning and sanitizing normally require the
following steps 1. Dry clean 2. Pre-rinse 3.
Detergent application (may include scrubbing) 4.
Post-rinse and 5. Sanitizer application.
66
  • CLEANING PROGRAMS

67
  • Where written cleaning programs are used, they
    should specify
  • areas, items of equipment and utensils to be
    cleaned
  • responsibility for specific tasks
  • method and frequency of cleaning
  • monitoring

68
  • CLEANING OF EQUIPMENT

69
  • CIP (clean-in-place).
  • manual
  • automatic
  • immersion
  • drying

70
  • CLEANING OF PREMISES

71
  • areas to be cleaned
  • methods of cleaning
  • person responsible and
  • frequency of the activity

72
  • DETERGENTS

73
  • General use
  • Alkaline or chlorinated detergents
  • Acid detergents
  • Enzymatic detergents

74
Cleaning effectiveness will depend upon several
basic factors
  • Contact time
  • Temperature
  • Physical disruption of the soil (scrubbing)
  • Water chemistry

75
  • SANITATION AGENTS

76
  • Chlorine
  • Quaternary Ammonium Compounds
  • Iodophors,
  • Acid sanitizers including acid-anionium,carboxylic
    and peroxyacetic acid types
  • Ozone
  • Ultraviolet(UV) irradiation
  • Hot (hot water)

77
PEST CONTROL
78
Preventing access
79
  • Entrance sites
  • External and Internal inspection
  • Assess the facilitys capacity for excluding
    pests.

80
Harborage and infestation
81
  • Availability of food and water
  • Effectiveness of cleaning and sanitation
    procedures

82
Monitoring and detection
83
  • Observations of the presence
  • Evidence of the presence

84
Eradication
85
  • Agents
  • Chemical
  • Physical
  • Biological

86
Waste Management
87
  • Storage Areas
  • Waste bins, tubs and dumpsters
  • Proper cleaning and sanitizing

88
  • SANITATION MONITORING EFFECTIVENESS

89
  • Sanitation systems program periodically verified
  • Audit pre-operational inspections,
  • Microbiological sampling of environment and food
    contact.

90
PERSONAL HYGIENE
91
  • Objective
  • To ensure that those who come directly or
    indirectly into contact with food are not likely
    to contaminate it.

92
HEALTH STATUS
93
  • Illness
  • Injuries
  • Individual Health Card

94
  • PERSONAL CLEANLINESS

95
  • Personal effects
  • Hand washing
  • Use of antiseptic on hands

96
  • UNIFORM

97
  • Uniform
  • Uniforms should be kept clean and in good
    condition.
  • Masks and gloves
  • should be used when a ready-to-eat food is
    prepared

98
  • PERSONAL
  • BEHAVIOR

99
  • Trained to be conscious of the importance of GMP
  • Unacceptable Action

100
VISITORS
101
  • Adhere to the same personal hygienic provisions
    described for food handlers.

102
TRANSPORTATION
103
  • OBJECTIVES
  • To protect food from potential sources of
    contamination and from damage likely to render
    food unsuitable for consumption
  • To provide an environment which limits growth of
    pathogenic or spoilage microorganisms and the
    production of toxins.

104
  • Requirements
  • design and construction
  • clean and/or disinfect
  • separate foods from non-food items
  • maintain temperature
  • verification of temperature
  • prevent contamination

105
  • VERIFICATION
  • - Inspection of vehicle
  • - Program describing effective cleaning and
    sanitation procedures
  • - Restrain transportation of non-food items
  • - Loading/unloading
  • - Design and construction of tank vehicles
  • - Materials used in vehicles for food
    transportation

106
PRODUCT INFORMATION AND CONSUMER AWARENESS
107
  • OBJECTIVES
  • All products should be labeled with sufficient
    information to ensure that the person in the next
    step of the food chain will understand how to
    handle, store, process, prepare and display the
    product safely and correctly
  • This information should contain a clear
    identification of the lot or batch in order to
    facilitate any necessary recall.

108
  • Lot identification

109
  • A lot is a defined quantity of a commodity
    produced under the same conditions.
  • Lot identification is essential to product
    recall and also contributes to effective stock
    rotation.

110
  • Product information

111
  • Adequate label information on food products
    enables the next person in the food chain to
    handle, display, store, prepare and use the
    product safely and correctly.

112
  • Labeling

113
  • Codex of General Standard for the Labeling of
    Prepackaged Foods (CODEX STAN 1-1985).

114
  • The minimum information required on prepackaged
    labels is
  • Name of the food
  • Ingredients
  • Net contents and drained weight

115
  • Name and address of manufacturer, packager,
    distributor, importer, exporter or vendor of the
    food
  • Country of origin
  • Lot identification
  • Date and storage instructions
  • Instructions for use.

116
  • Consumer education

117
  • Health education programs should cover general
    food hygiene
  • Helping consumers to understand the importance of
    reading labels, following instructions for use,
    and making correct choices
  • Information on the relationship between
    time/temperature control and foodborne diseases

118
TRAINING
119
  • Awareness and responsibilities
  • Training programs
  • Instruction and supervision
  • Refreshing training
  • Minimum program for GMP training courses
  • Code of Hygyenic Practices - Codex Alimentarius
    Commission

120
Minimum program forGMP training courses
  • Primary production
  • Design of plant and facilities
  • Control of operations
  • Plant maintenance and sanitation

121
  • Transportation
  • Product information and consumer awareness
  • Training
  • GMP evaluation.

122
GOOD MANUFACTURING PRACTICE EVALUATION
123
  • Verification
  • Audit
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