GMP & GHP
Dr. Amira Gawdat
• Good Manufacturing Practices (GMP):
• Those procedures for a particular manufacturing
operation which practitioners of, and experts in,
that operation consider to be the best available
using current knowledge.
• Good Hygienic Practices (GHP): all practices
regarding the conditions and measures necessary
to ensure the safety and suitability of food at all
stages of the food chain
The terms GMP and GHP therefore basically cover
the same ground
GMP & GHP
• GMP: management approach and process controls
(including suppliers).
• GHP: system for maintaining hygiene and sanitation
GMP
• GMP: management approach and process controls
(including suppliers).
• Deals with:
specifications;
calibration ;
equipment;
traceability and recall;
equipment designs (for food safety),
maintaining and monitoring;
light and ventilation systems;
storage conditions;
control of operations; etc.
GHP
• GHP: system for maintaining hygiene.
• Regards:
personal hygiene,
employee health,
working conditions,
maintenance of plant and equipment,
hygiene of food contact surfaces,
pest control,
waste disposal,
water quality,
toilet and hand wash facilities,
prevention of cross contamination, etc.
GHP (under the name of food hygiene)
FAO
Codex
Alimintarius
(Food Law)
WHO
GMP
Food, Drug & Cosmetic Act (FDCA), 1938
• Gave regulatory power to FDA over foods
• Requirements for GMP’s are listed in 21 CFR 110
• Section 402(a)(4) of FDCA contains provisions for “adulterated”
GHP
Areas examined under GHP
1. Primary production
2. Establishment: design and facilities
3. Control of operation
4. Establishment: maintenance and sanitation
5. Establishment: personal hygiene
6. Transportation
7. Product information and consumer awareness
8. Training
1- Primary production
• Hygienic practices should reduce the likelihood of
introducing hazards that may be difficult or
impossible to control at later stages of the food
chain
• Examples: pesticides, antibiotics, mycotoxins,
microorganisms in foods eaten raw or fresh
2- Establishment : design
• Premises, equipment, surfaces and facilities should
be located, designed and constructed in a way to
ensure:
minimum contamination
proper maintenance, cleaning, disinfection
protection against pests
2- Establishment : design
Evaluation of the premises takes into account:
1. Location
2. Equipment
3. Facilities :
• water
• air
• lighting
• storage
Examples of hygienic
equipment design
Practice
• “Good housekeeping” applies to the surroundings
and the roof of the establishment
• Pest control starts at the boundaries of the premises
• Water management deals with incoming and used
water
• Windows are closed or screened
• Internal surfaces are smooth and easy to clean
• Floors have rounded corners
• Ceilings and ducts are accessible for cleaning
Practice
• Dry zones are designed to remain dry
• Drains can be cleaned
• Cable trays carry cables, not dirt or dust
• Only potable water is in contact with food
• Air handling systems deliver the required air
quality (and not contaminants)
• Doors are closed when not used
3- Control of operation
• Control of food hazards introduction
• Hygiene control:
1. Time & temperature
2. Humidity
3. Contamination
• Incoming materials (incl. packaging materials)
• Water, air, steam
• Management, documentation, recall procedures
Practice
• Keep potentially contaminated materials separated
from uncontaminated ones
• Assure effectiveness of treatments
• Assure effectiveness of cleaning
• Assure reliability of measurements, tests and
recording
• Perform hazard analysis when changes occur
• Assure updating of HACCP plan
4- Establishment :
maintenance & sanitation
• Objective to control possible sources of food
contamination through:
• Maintenance and cleaning
• Pest control systems
• Waste management
• Monitoring
Maintenance
Establishments and equipment should be
kept in condition to:
• facilitate sanitation procedures
• function as intended, particularly at Critical
Control Points (CCPs)
• prevent contamination of food e.g.debris,
chemicals,pests, dust etc.
Cleaning
Cleaning procedures involve:
• removing gross debris from surfaces
• applying a detergent solution
• rinsing with water
• disinfection where necessary
• dry cleaning
Pest Control
Good hygienic practices should:
• prevent pests from entering the premises
• protect food from pests
• eradicate infestations immediately
• include regular inspections
5- Establishment: personal hygiene
• clean protective clothing, footwear, hair- and
beardnets, caps or other effective hair restraints
must be issued by the company and should be
worn in the processing area only
• nail varnish, false nails and eyelashes, watches
and jewellery should not be worn in processing
area
• personal items (handbags, shopping bags, etc.)
must not be taken into processing area
5- Establishment: personal hygiene
• eating food or sweets, chewing gum, drinking beverages or using
tobacco should not occur in any processing area and spitting
should be forbidden
• an effective hand washing program should be implemented,
including:
• how to wash hands:
– wet hands with warm water
– lather and rub using warm water
– rinse
– dry with disposable towels or
– disinfect by dipping in sanitizing solution (iodine or 100 ppm
chlorine).
5- Establishment: personal hygiene
• when to wash hands:
before starting work - in the mornings and after
breaks
after visiting the toilet
after coughing and sneezing
after handling soiled equipment
6- Transportation
• Measures should be taken to :
• protect food from :
i) contamination sources
ii) damage likely to render the food unsuitable for
consumption
• provide an environment which controls the growth of
pathogenic or spoilage microorganisms and the
production of toxins in food (accordingly) .
7- Product information and
consumer awareness
• Product information
• Labelling
• Consumer education
• Consumers should know enough about food hygiene to be
able to :
understand the importance of product information
make informed choices appropriate to the individual
prevent contamination and growth or survival of food
borne pathogens by storing, preparing and using it
correctly
8- Training
• Awareness and responsibilities
• Training program
• Instruction and supervision
• Refresher training
GMP
GMP AND Current GMP
• GMP is also sometimes referred to as "cGMP". The
letter "c" stands for "current," reminding
manufacturers that they must employ technologies
and systems that are up-to-date in order to comply
with the regulation.
cGMP
• Subpart A—General Provisions
• Definitions.
• Current good manufacturing practice.
• Personnel.
• Exclusions.
• Subpart B—Buildings and Facilities
• Plant and grounds.
• Sanitary operations.
• Sanitary facilities and controls.
• Subpart C—Equipment
• Equipment and utensils.
• Subpart D [Reserved]
cGMP
• Subpart E—Production and Process Controls
• Processes and controls.
• Warehousing and distribution.
• Subpart F [Reserved]
• Subpart G—Defect Action Levels
• Natural or unavoidable defects in food for human use that present
no health hazard.
cGMP
cGMP
cGMP
cGMP
Reserved Subparts
• Subpart D—Regulatory Limits for Added Poisonous
or Deleterious Substances [Reserved]
• Subpart F—Naturally Occurring Posionous or
Deleterious Substances [Reserved]
KEY MESSAGES
• Good Manufacturing Practices are the basis of
the production and preparation of safe food
• Good Hygienic Practices deal with safety and
suitability requirements to be followed world-
wide
• Each food operation should adapt existing codes
to their specific set of conditions
• Food operations should also decide which
practices are critical for the safety of a product
and thus have to be included in the HACCP plan
Thank You
