PART II GOOD MANUFACTURING PRACTICES (GMP)

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PART II GOOD MANUFACTURING PRACTICES (GMP)
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GMP

• Prerequisite programs which will provide the
  basic environmental and operating conditions that
  are necessary for the production of safe and
  wholesome food.

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SSOP Sanitation Standard Operating Procedures
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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

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• 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

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

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

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

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IMPORTANT ASPECTS

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

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• 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

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• 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

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

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• 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

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

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CLEANING, MAINTENANCE AND PERSONNEL HYGIENE

• Appropriate facilities and cleaning procedures

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• ESTABLISHMENT DESIGN AND FACILITIES

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

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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.

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• 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.

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

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

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

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• 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.

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

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CONTROL OF OPERATIONS
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• 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.

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Control of Food Hazards
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• 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.

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

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• 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.

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• 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

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

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

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

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

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

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Microbiological cross contamination
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• 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.

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

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

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PACKAGING
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• Packaging materials
• Protection of food
• Prevent recontamination

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

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• Ice making
• Steam production
• Drainage
• Plumbing

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

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• Monitoring
• Correcting deviations
• Records
• Water standards WHO

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MANAGEMENT AND SUPERVISION
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• 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

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DOCUMENTATION AND RECORDS
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Monitoring time Legibility Revising and
updating records
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RECALL PROCEDURES
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• 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.)

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

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

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• Biofilm
• Adhesion
• Protection
• Resistance

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• CLEANING PROCEDURES AND METHODS

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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.
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• CLEANING PROGRAMS

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• 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

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• CLEANING OF EQUIPMENT

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

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• CLEANING OF PREMISES

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

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• DETERGENTS

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

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Cleaning effectiveness will depend upon several
basic factors

• Contact time
• Temperature
• Physical disruption of the soil (scrubbing)
• Water chemistry

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• SANITATION AGENTS

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

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

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

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

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Eradication
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• Agents
• Chemical
• Physical
• Biological

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

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• SANITATION MONITORING EFFECTIVENESS

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

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

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HEALTH STATUS
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• Illness
• Injuries
• Individual Health Card

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• PERSONAL CLEANLINESS

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

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• UNIFORM

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

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• PERSONAL
• BEHAVIOR

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

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

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TRANSPORTATION
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• 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.

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

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• 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

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PRODUCT INFORMATION AND CONSUMER AWARENESS
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• 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.

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• Lot identification

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• 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.

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• Product information

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• 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.

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• Labeling

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

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

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• 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.

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• Consumer education

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• 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

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

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Minimum program forGMP training courses

• Primary production
• Design of plant and facilities
• Control of operations
• Plant maintenance and sanitation

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

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GOOD MANUFACTURING PRACTICE EVALUATION
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• Verification
• Audit