GMP Qom

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GMP in Food Industries
Presentation · November 2018

DOI: 10.13140/RG.2.2.32482.58563
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Arasb Dabbagh Moghaddam

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GMP in Food Industries
BY:
Dr. Arasb Dabbagh Moghaddam
(DVM-MSc-PhD)
https://www.researchgate.net/profile/Arasb_Dabbagh_Moghaddam
Member of Food Hygiene & Safety

Committee of IRVC
1 Dr. Arasb Dabbagh Moghaddam

WHAT IS GMP ?
GOOD
MANUFACTURING
PRACTICE
DEFINITIONS

Good Manufacturing Practices
(DEFINITION 1)
IFST (UK):
The combination of manufacturing and quality
control procedures aimed at ensuring that
products are consistently manufactured to
their specifications.

(DEFINITION 2)
FDA / USDA FOOD, DRUG & COSMETIC ACT:
Minimum sanitary and processing requirements

applicable to all companies processing foods to
ensure wholesomeness.
WHOLESOME= Not Adulterated

Difference between cGMP & 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.

Food Safety
Codex 1997:
Assurance that food will not cause harm to the
consumer when it is prepared and/or eaten
according to its intended use.

Food Suitability
Codex 1997:
Assurance that food is acceptable for human
consumption according to its intended use.

Contaminants
Codex 1997:
Any biological or chemical agent, foreign
matter, or substances not intentionally added
to food which may compromise food safety or
suitability.

Contamination
The introduction or occurrence of a

contaminant in a food or food environment.

Cleaning
Codex 1997:
The removal of soil, food residue, dirt, grease
or other objectionable matter.

Disinfection
The reduction, by means of chemical agents

and/or physical methods, of the number of
microorganisms in the environment, to a level
that does not compromise food safety or
suitability.

What is the Importance of
GMPs?
Required actions or conditions to prevent harm to human beings.
Avoid production of unsanitary, contaminated, adulterated or

dangerous product.
Many countries have adopted these as laws or federal

regulations.
GMPs are the basis of the production and preparation of safe
13 food. Dr. Arasb Dabbagh Moghaddam

15
GMP Benefits
1. Good Business Practice
2. Improved Product Consistency
3. Helps to Lower Costs
4. Builds Future Business
5. Legal Requirements
Necessary key elements for GMP
 qualified and trained personnel,

 adequate premises and space,
 suitable equipment and services,
 correct materials, containers and labels,
 approved procedures and instructions,
 suitable storage and transport.

The Essentials of GMP

Management commitment and
continual improvement
 GMP starts with good people.

 There should be low turnovers within the
management team.
 Plus, Management should be committed to
continuous improvement within the
workplace, management team and staff.

GMPs cover all parts of the business
1) Primary production
2) SOP’s- Standard Operating Procedures
3) Sanitation, Hygiene and Maintenance
4) Good House Keeping
5) Facility Design and Plant Layout
6) Process Control
7) Documentation and Record Keeping
8) Personnel- Hygiene, Behavior and Dress
9) Transportation
10) Product information and consumer awareness
20 11) Training Dr. Arasb Dabbagh Moghaddam
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.
Raw materials & Other ingredients: Use proper, safe materials

according to regulations & specifications (ex. raw produce, spices,
ingredients, containers)
Receipt & inspection of raw materials, testing and evaluation to

21 minimize contamination.
GMP REQUIRES THAT COMPLETE RECORDS ARE KEPT ON
ALL NEWLY RECEIVED COMPONENTS.
 Proper identification
 When received and inspected?
 Who did the inspection?
 Who took samples ?
 When were they tested?
 Who did the test?
 ?????

After testing and examination by quality control
…….
It may then be approved and released for manufacturing use!

2. SOPs- Standard Operating Procedures
SOPs:
Establish or prescribed methods to be followed routinely for the
performance of designated operation.
SOPs:
Detail a specific sequence of events to perform a task
Ensures standardization of processing operations
Allow to establish operative limits, monitoring procedures and

corrective actions.
2. SOP’s- Standard Operating
Procedures (cont.1)
A) Document the way to do things:

Must be written down.
Step by Step procedures
Must include formulas, processing, and sanitation.
B) SOPs must be followed:
Product Consistency
Product Safety
Legal Requirements

3. Sanitation, Hygiene & Maintenance
A) Written Detailed Instructions
B) Applies to Processing Equipment
C) Applies to Support Equipment
D) Applies to the Physical Plant Facility
E) Applies to Environment Surrounding the Plant.

(cont.1)
Objective:
To control possible sources of food contamination
through:
Maintenance and Cleaning
- Ways of cleaning not affect product.
Pest Control System
Waste Management
27 Monitoring Dr. Arasb Dabbagh Moghaddam

(cont.2)
Establishments and equipment should be kept

in condition to:
Facilitate Sanitation Procedure.
Function as Intended.
Prevent contamination of food e.g. metal shards,

flaking plaster, debris, chemicals, pests, dust, etc.

(cont.3)
Control of measuring devices:

Equipment Control, Maintenance & Calibration
Traceability of calibrated equipment.

4. Good Housekeeping
A) Operational
B) Storage Area
C) Administrative
D) Support Areas

4. Good Housekeeping (cont.1)
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.
Removing gross debris from surfaces:

- Properly clean food contact surfaces
- food contact surfaces (equipment & utensils) properly
cleaned and stored when not in use.
Applying a detergent solution: Proper use of right

type of solutions which are properly stored.
Rinsing with water.
Disinfection where necessary

32 Dry cleaning Dr. Arasb Dabbagh Moghaddam
Master Sanitation List
Identifies Schedule for Cleaning Entire Plant:

Top to Bottom
Front to Back

SSOP – Sanitation Standard Operating Procedures
A) What/ Where / When / Who / How?

Written Procedures with Details.
B) Cleaning & Sanitizing

Cleaning utilizing chemical cleaners diluted in water and
applied to surfaces manually or mechanically.
Sanitizing using chemical sanitizers applied to already CLEAN

surface to further reduce the bacterial population.
C) many Different Chemicals are Available:

Caustic Compounds
Acid Cleaners
Quaternary Ammonium Compounds (QUAT)
Chlorine Compounds (Household Bleach)
Iodine Compounds

4. Good Housekeeping(cont.6)
PEST CONTROL
Prevent pests from entering the premises.
Protect food from pests
Eradicate infestations immediately.
Include regular inspection.
Proper exclusion methods for pests which do not

contaminate product.

Pest Control
1) Use a trained, licensed, insured pest control

operator:
A. Must use approved insecticides and rodenticides for
application in food plants.
B. Frequency of service should be a minimum of once a

month.

2) Outside Premises Management

A. Clean areas around building.
B. Remove all junks and trash.
C. Remove all vegetation from around building
D. Bait station approx. every 15 meters.
E. Must use solid block bait. Do NOT use bait.

3) Inside Premises Management

A. NO poison bait station permitted anywhere inside buildings.
B. Traps & glue boards are permitted in:

Warehouse / Cold Storage / Employee Welfare Area / Offices
Trapping devices are Not permitted in processing areas.
C. If insecticides are used in the plant, all equipment must be re-washed

before use.
D. ILT’s (Insect Light Traps) are NOT recommended for processing areas.

5. Facility Design & Plant Layout
Evaluation of the premises takes into account:
Location
Equipment:
- Design: Positioned at least 50 cm away from the wall & floor
- Materials: St.St. (Stainless Steel), Food Grade
- Ability to be cleaned and sanitized (Freezer &

Cold storage, Conveying, Instruments)

(cont.1)
Facilities:
- water
- air
- lighting
- storage
- ventilation
Grounds: not attract pest, no dust, no poor drainage, etc
Product Flow (Raw to Cooked)

- Minimum contamination
- proper maintenance, cleaning, disinfection
- protection against pest.
(cont.2)
Sanitary Facilities
• Trapped drains
• Toilets: Not opening into processing floor, adequate and accessible to

employees, equipped & maintained cleaned.
• Water Supply: Adequate in quantity, quality, temp. & pressure.
• Plumbing: Bring in enough water and able to take it away, adequately sized,
designed, installed & maintained to prevent contamination.
• Sewage Disposal: Adequate to dispose of sewage.
• Hand-Washing Facilities: Accessible to employees where necessary
42 • Rubbish & Offal Disposal: Trash properly stored & removed

(cont.3)
Construction Materials
• NO wood
• Smooth impervious surfaces
• No rust, rope, or tape.

(cont.4)
Establishment:
• Allow for cleaning and control of area.
• Drains can be cleaned.
• 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.
• Windows are closed or screened.

(cont.5)
• Internal surfaces are smooth and easy to clean.
• Floors have rounded corners.
• Ceilings and ducts are accessible for cleaning
• Dry zones are designed to remain dry.
• Pedestrian gangways must be available to

avoid congestion and ultimately accidents.

47
6. Process Controls
A) Responsibility for overall plant sanitation specifically assigned to an

individual.
B) Chemical, microbiological or extraneous material testing procedures

used where necessary to identify sanitation failures.
C) Packaging processes & materials adequate to prevent contamination.
D) Only approved food and/or color additives used.
E) Products coded to enable lot identification and record maintained in

excess of expected shelf- life.

6. Process Controls (cont.1)
F) Weighing & measuring practices adequate to ensure the declared
quantity of contents.
G) Written Procedures.
H) Documented Master Formulas (DMF)

NO Changes Allowed
I) Documented Batch Sheets.
J) Production and Processing information on day’s run.

6. Process Controls (cont.2)
K) Use proper, safe procedures to produce, handle, store and

transport product (ex. Temperature, washing, pH, water activity)
L) Ice (where used) manufactured from potable water, stored &

handled in a sanitary manner.
M) Finished products stored & shipped under conditions which will

avoid contamination & deterioration.
N) Glass is strictly prohibited in food production & storage areas

unless it is the primary packaging medium.

Warehouse
 It shall be clean.
 Sections clearly identified
(quarantine, released,
rejected)
 quarantine - yellow
 released - green
 rejected - red
 First In - First Out (FIFO)
 Track inventory and sold
lots (quantities to where)

7. Documentation & Record Keeping
 Documentation is the key to GMP

compliance and ensures traceability of all
development, manufacturing, and testing
activities.
 Documentation provides the route for
auditors to assess the overall quality of
operations within a company and the final
product.

7. Documentation & Record Keeping
A) If it is NOT written down- It did NOT happen.
B) Correct Mistakes in Documents.
C) Use Permanent Ink- No Erasures.

Legible and clear.
Accurate and complete
Permanent- Keep for a minimum of 2 years.

8.Personnel- Hygiene, Behavior & Dress
A) Smoking- Eating- Drinking- Chewing Gum:
Never in food processing or packaging area.
B) Hair Covering:
Head / Facial / Beard / Mustache Hair.
Arms / Arm pits / Chest / Body hair.

Cover your hair which
have dust & germs.
Prevent hair from

falling into the
product.
Cover the nose and
mouth which are
natural reservoir of
germs.
55 Trap particles or
8.Personnel- Hygiene, Behavior & Dress
(cont.1)
C) Jewelry:
No Loose or Dangling Ornaments.
No Rings or Wrist Watches: covering or removing hand jewelry that

cannot be sanitized.
No Loose Items in Pockets Above Waist.
Removing unsecured objects that might fall into food, equipment or

containers.

8.Personnel- Hygiene, Behavior &
Dress (cont.2)
D) Clothing (1):
Wearing Working Gear (Hair nets, Face masks, etc.), using cloth
storage.
Clean and Appropriate.
Aprons- Washed After Each Use.
Protective Footwear.
Personal clothing such as body warmers must not be worn over
protecting clothing.

8.Personnel- Hygiene, Behavior &
Dress (cont.3)
D) Clothing (2):
Protecting clothing & footwear must not be worn by staff outside the
factory.
Ear plugs or ear muffs must be accounted for at the end of each shift.
A twice weekly change of overall / hats is recommended unless the job in
hand is a particularly dirty operation.
Color coding of protective work wear is essential in high risk or multi-
disciplinary to identify specific roles e.g. engineers, cleaners, distribution
personnel etc.

8.Personnel- Hygiene, Behavior & Dress (cont.4)
E) Health Status: Free from Diseases (sores, infections,

etc), Illnesses and Injuries.
F) Personal Cleanliness:
Maintaining adequate personal cleanliness
* Strong perfumes are not allowed because
of the possibility of taint.
G) Personal Behavior
8. Personnel – Hygiene, Behavior & Dress
(cont.5)
H) Hand Washing
1) Frequent – Enforced
2) Warm Water
3) Soap
4) Disposable Towels
5) Hand sanitizer – Alcohol / QUAT / Chlorine
6) Short and Clean Finger Nails – No Fake Nails
7) Disposable Gloves for Cooked Products.

hand washing notes
 The use of 3 to 5 ml antiseptic soap was sufficient; more than 1 ml
non-antiseptic soap did not enhance cleaning.
 A washing duration of 5 to 30 seconds can be effective.
 Mechanical action aids in the reduction of transient microorganisms.
 Washing for 2 minutes removes only 3% more transient

microorganisms than washing for 15 seconds.
 Washing in warm water (50 °C) removes more microorganisms than

washing in cool water (20 °C).

hand washing notes
 Washing for 3 minutes actually results in greater microbial
counts as resident organisms (those present deeper in the
skin) are brought to the surface.
 The presence of rings on the fingers may or may not result

in greater bacterial counts on the hands after washing.
 The residual effects of antimicrobial products depend upon

the chemical composition.
 Hot air dryers may or may not increase the bacteria

population on the hands.

hand washing notes
 The use of single-use paper towels and clean single-use cloth
towels aid in the reduction of bacteria.
 Complete hand drying is critical to reduce recontamination.
 Roll-type cloth towels are a source of recontamination.
 Buttons, levers and crank-on towel dispensers are sources

of recontamination.
 Automatic hand washing machines produce more consistent

and effective results.

crank-on towel dispenser

Automatic hand washing machine

hand washing notes
 The use of gloves can lessen the frequency

and effectiveness of hand washing.
 Gloves can be as significant a source of

contamination as hands.
 Gloves tend to be changed less frequently

than actually needed.

Frequency of hand washing
 Research has shown that washing the hands

more than 25 times per day can result in
higher microbial counts.
 This situation occurs because the protective

barriers inherent in the skin are damaged.
 Thus, the frequency of hand washing must be

evaluated to ensure detrimental effects are
avoided.

8.Personnel–Hygiene, Behavior & Dress (cont.6)
I) Visitors
1) Signed in on LOG Book.
2) Properly Identified.
3) Accompanied.
4) No Pictures

9. Transportation
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.
Handled in way to protect & maintain product condition.

10. Product Information & Consumer
Awareness
Lot Identification
Product Information
Labeling
Consumer Education

10. Product Information & Consumer
Awareness (cont.1)
CONSUMER INFORMATION
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

11. Training
Awareness and Responsibilities: know proper food handling techniques
Training Programs
Instruction and Supervision: responsible for employee compliance.
Refresher Training.
Engineers trained in hygiene procedures particularly personal hygiene &

product protection.
Picture based guides providing key hygiene instructions should be

made available to overcome language problem.
Thank You for your Attention!!
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See discussions, stats, and author profiles for this publication at: https://www.researchgate.

GMP in Food Industries

Presentation · November 2018

Arasb Dabbagh Moghaddam

Epidemiology of Infectious Diseases in Army View project

Covid-19 View project

The user has requested enhancement of the downloaded file.

Member of Food Hygiene & Safety

1 Dr. Arasb Dabbagh Moghaddam

3 Dr. Arasb Dabbagh Moghaddam

4 Dr. Arasb Dabbagh Moghaddam

FDA / USDA FOOD, DRUG & COSMETIC ACT:

Minimum sanitary and processing requirements

5 Dr. Arasb Dabbagh Moghaddam

 GMP is also sometimes referred to as

6 Dr. Arasb Dabbagh Moghaddam

7 Dr. Arasb Dabbagh Moghaddam

8 Dr. Arasb Dabbagh Moghaddam

9 Dr. Arasb Dabbagh Moghaddam

The introduction or occurrence of a

10 Dr. Arasb Dabbagh Moghaddam

11 Dr. Arasb Dabbagh Moghaddam

The reduction, by means of chemical agents

12 Dr. Arasb Dabbagh Moghaddam

Good Manufacturing Practices

Required actions or conditions to prevent harm to human beings.

Avoid production of unsanitary, contaminated, adulterated or

Many countries have adopted these as laws or federal

GMPs are the basis of the production and preparation of safe

13 food. Dr. Arasb Dabbagh Moghaddam

1. Good Business Practice

2. Improved Product Consistency

3. Helps to Lower Costs

4. Builds Future Business

 qualified and trained personnel,

17 Dr. Arasb Dabbagh Moghaddam

18 Dr. Arasb Dabbagh Moghaddam

 GMP starts with good people.

19 Dr. Arasb Dabbagh Moghaddam

Hygienic practices should reduce the likelihood of introducing hazards

Raw materials & Other ingredients: Use proper, safe materials

Receipt & inspection of raw materials, testing and evaluation to

 When received and inspected?

 Who did the inspection?

 Who took samples ?

 When were they tested?

 Who did the test?

22 Dr. Arasb Dabbagh Moghaddam

It may then be approved and released for manufacturing use!

23 Dr. Arasb Dabbagh Moghaddam

Ensures standardization of processing operations

Allow to establish operative limits, monitoring procedures and

A) Document the way to do things:

25 Dr. Arasb Dabbagh Moghaddam

A) Written Detailed Instructions

B) Applies to Processing Equipment

C) Applies to Support Equipment

D) Applies to the Physical Plant Facility

E) Applies to Environment Surrounding the Plant.

26 Dr. Arasb Dabbagh Moghaddam

27 Monitoring Dr. Arasb Dabbagh Moghaddam

Establishments and equipment should be kept

Prevent contamination of food e.g. metal shards,