This document outlines Good Manufacturing Practices (GMP) for food production. It discusses key principles of GMP including documentation, validation, sanitation, personnel training, auditing, and process and quality control. The goal of GMP is to consistently produce safe, pure, and effective products by establishing controls and standards at all stages of manufacturing.

1. Good Manufacturing Processing
GMP
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2. GMP Introduction
GMP Benefits
Principles of GMP
GMP Key Provisions
List of Contents
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3. GMP
• Good Manufacturing Practices are a set of practices that are required in order to comply with
industry standards and regulations.
• Helps to minimize the risks involved during manufacturing and helps to ensure products meet
quality and regulatory standards.
• Ensures that products are consistently produced and controlled according to predefined
quality standards.
• cGMP stands for Current Good Manufacturing Practices. This means that some conventions or
practices are subject to change within the industry.
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4. Helps to reduce observations raised
on inadequate documentation practices.
Ensures products are safe for humans.
Helps Prevent and
control contamination and cross contamination.
Reduces the risk of mislabeling and
adulteration.
Promotes efficiency and reduces the
cost of doing business.
GMP Benefits
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5. 1. Writing step-by-step operating procedures and work instructions.
2. Following written procedures and instructions at all times to prevent
contamination, mix-ups and errors.
3. Documenting work accurately and in a timely fashion.
4. Proving that systems do what they are designed to do by validating equipment
systems and processes.
5. Designing and constructing facilities and equipment.
6. Monitoring and maintaining facilities and equipment.
7. Defining, developing and demonstrating job competence.
8. Protecting against contamination and maintain a clean environment.
9. Controlling raw materials, components and product related processes.
10. Conducting planned and periodic audits.
Principles of GMP
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6. • Stress the importance of written procedure.
• The best way to comply with GMP is to have well written procedures and carefully following
them.
• Give us the controls necessary to minimize the chance of contamination, mix-ups and Errors.
Principles 1&2
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7. Documentation:
Recording of each significant
step we perform as we complete a
job task.
Shall made promptly, accurately
and in accord with written
procedures.
Any document that can impact the
quality of the product or product
safety is treated as a controlled
document.
Examples of controlled
document:
Policies, SOPs, Specifications,
MFR (Master Formula Record)
The accuracy and content of
these documents can be
subject to review by regulatory
bodies Including the FDA.
Principle 3
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8. Validation:
Proactive proof that we can produce safe and effective products.
Requires a series of tests to assure our systems do what we say they do.
Gives meaning to documentation we make.
Tells us written procedures are correct and our products are truly safe.
Principle 4
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9. • Key concern of principle 5&6: Avoid the possibility of contamination,
mix-ups and errors in work place. Keeping certain areas such as
cafeteria , restrooms and locker
rooms separated from
manufacturing area.
Principle 5 &6
Water, air, temperature and humidity
should be controlled in order to avoid
mix-ups and errors.
• GMP requires competent personnel who perform the job right every time.
• Personnel should be properly trained.
• Company must have formal training program to assure each employee can
competently preform assigned job.
Principle 7
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10. • Focuses on cleanliness and requires us to constantly be on-guard to defend our
product against contamination.
A) Particular Contamination:
Product has been made impure by any particle that does not belong in it.
Examples: Dust, dirt, hair.
B) Microbial contamination:
Caused by microscopic organisms that are living organisms that exist on everything in
environment that is not sterilized.
Examples: Fungus, mold, bacteria and viruses.
C) Cross Contamination:
Occurs when traces of other materials, components and products adulterate or miss
brand a product that we are currently manufacturing or testing.
Principle 8
Contamination
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11. Material and Components
• Satisfy our quality standards.
• Upon receipt must be carefully
examined for damage and
contamination.
• Certain components and
materials must be sampled and
tested to ensure that they
meet the established identity,
quality and purity.
• After approval they are
released to manufacturing and
used on first in first out
basis.
Manufacturing Process
• Master records that outline
specifications and
manufacturing procedures.
• Individual batch or history
records to help to document
the conformance to master
record.
• Written schedules and
procedures for cleaning and
maintaining equipment.
Packaging and Labeling
• Inspect packaging and labeling
area before each new batch is
processed.
• Packaging equipment is clean
and the area does not contain
any materials from previous
run.
Testing
• Supports all other areas of
control.
• Must be performed by
qualified individuals.
• Assures the safety,
effectiveness and purity of
product as they enter
marketplace.
Principle 9
 Controls raw materials, components and product related processes.
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12.  FDA has major responsibility to externally audit manufacturing operations to see if we are in compliance
with cGMP regulation.
 FDA has the responsibility to protect the consumer and can recommend a recall product if a product is
contaminated, miss-labeled or is not manufacture in compliance with cGMP regulations.
 Company has the responsibility to internally ensure the integrity of products.
Principle 10
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13. SAFE
the product has the r
ight ingredients . It is
packaged as intended
and correctly labelled
in order to provide
identification and
safe use.
PURE
it is free of contamin
ants, foreign matter,
chemicals and harmful
microbes.
UNIFORM
The product is manuf
actured consistently a
nd will have the same
quality between
batches manufactured
on different days.
EFFECTIVE
Product requires the
correct ingredients,
the correct amount of
ingredients and
correct packaging to
maintain the product
stability over time.
The Aim of GMP Key Provisions of GMP
GMP
General
Provisions
Building
and
facilities
Equipment
Production
and
process
control
Defect
Action
level
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14. 1-1 Terminology
Defines much of the terminology used in describing GMPs.
Examples in Dairy Company:
• Cleaning Work Area: Work area with high requirement for cleanness, such as storage area, Filling room
and inner packing area
• Quasi-Cleaning Work Area: Work area with requirement for cleanness next to that of cleaning work area,
such as pretreatment workshops of raw materials.
• Commonly-Cleaning Work Area: Work area with requirement for cleanness next to quasi-cleaning work
area, such as milk collection unit, raw material warehouse, and packaging material warehouse.
1.General Provision
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15. 1-2 Personnel
Personnel Hygiene and Cleanliness
• Enterprises shall establish and execute the employees’ health
management system.
• Milk processing and operation personnel shall annually undertake
the health check and obtain the health certificate before being
put in to work.
• Persons Suffering from infectious disease of digestive tract as
dysentery, Typhoid, Viral hepatitis type A and type E, active
pulmonary tuberculosis and persons with skin injuries shall be
transferred to other positions not impacting the food safety.
• Before entering the production workshop, it is a must to wear or
put on the clean work uniform, cap and shoes or boots.
• Removal of jewelry and other unsecured objects, glove
maintenance,
• Use of hair restraints, appropriate storage of personal items,
and restrictions on various activities, such as eating and
smoking.
1.General Provision (Cont’d)
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16. Food Safety Education and Training
• Competent and educated personnel.
• A training system shall be established and the food safety knowledge training shall be
conducted to all the employees.
• Enterprises should set the annual training program according to different position needs and
training the staffs correspondingly.
• Training should be recorded.
Assignment of Supervisory Personnel to Ensure Compliance
• Relevant record management system shall be established.
• All the records shall be checked and signed or stamped by the executor and relevant
supervisor.
• All the production and quality management records shall be reviewed by the relevant
department.
1.General Provision
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17. • Outlines requirements for the maintenance, layout, and
operations of food processing facilities.
2-1
Any construction, expansion and reconstruction project shall
be designed and executed according to the relevant national
regulations.
2-2 Internal Building Structure
• Interior roofs and the top angles in processing, packing and
storage areas should be easily cleaned to minimize the
build up of dirt and condensation, the grown up of the mold
and the shedding of particles.
• Walls should be constructed with non-toxic, odorless,
smooth, water-proof, easy-to-clean, light-color, and anti-
corrosion materials.
• Smooth and anti-absorption materials shall be used for
doors and windows which should be easy to clean and
disinfect.
2.Building and Facilities
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18. • Describes the requirements and expectations for the design, construction, and maintenance of
equipment and utensils so as to ensure sanitary conditions.
• All the production equipment shall be orderly arranged as per technical procedures to avoid
any cross contamination.
• Monitoring equipment for measuring, controlling and recording as pressure gauge and
thermostat, should be calibrated periodically to ensure accuracy and effectiveness.
• It is necessary to establish the daily maintenance and service schedule for equipment and
carry out regular overhaul and keep proper records.
3. Equipment
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19. • Lists the general sanitation processes and controls necessary to ensure that food is suitable for human
consumption.
• Addresses the monitoring of physical factors (critical control points), such as time, temperature,
humidity, pH, flow rate, and acidification.
 Example in milk pasteurization:
• Outlines very general requirements for warehousing and distribution.
 Example in dairy products:
It shall avoid any direct sunlight, rain, rapid temperature and humidity change and sharp strike during
transporting and storing products.
Temperature Time
63 °C 30 minutes
72 °C 15 seconds
89 °C 1.0 Second
Temperature Time
90 °C 0.5 second
94 °C 0.1 second
96 °C .05 second
4.Production and Process Controls
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20. • Allows FDA to define maximum defect action levels (DALs) for a defect that is natural or
unavoidable.
• Generally, these defects are not hazardous to health at low levels; they include rodent filth,
insects, or mold.
5. Defect action levels (DALs)
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21. • www.fda.org
• cGMP Starter guide.
• www.ispe.org
Resources
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