GMP Trainers Manual PDF
GMP Trainers Manual PDF
GMP Trainers Manual PDF
Introduction p
The GMP training introduces the participants to the basic principles of food safety, hygiene and
sanitation. It discusses the food safety hazards and how to adequately control them. This GMP course
lays the foundation where the other food safety management systems build upon.
The training is designed for individuals of all levels within a food manufacturing organization. QA, QC,
production as well as Regulatory Affairs and general management positions will be able to better
understand the issues at stake as per GMP requirements.
The course materials comprise of this Trainer’s Manual and the Trainees Handouts.
The objective of the trainer’s manual is to guide the trainers in the preparation, discussion and delivery
of each session.
In most sessions, there are trainer’s tips and suggested readings to prepare the trainer on the subject
matter.
For the workshops, the specific worksheets consist of instructions and templates, as
applicable. Discussion of the workshop outputs are done after every workshop and relate learnings with
the objective(s) of the workshop.
The training programmes have been prepared to allow the would-be trainers and would-be food
practitioners the knowledge on GMP. However, it is essential that the would-be trainer has sufficient
first-hand experience of the food manufacturing to be able to provide examples and case studies, both
during the presentations and in the group sessions. It is also important that local issues are considered
throughout the course.
To test the understanding on the completed sessions, quiz may be given by the trainer. Suggested quiz
questionnaires and answer keys are provided per session.
Learning Objectives
Target Audience
Food sector
• Food handlers
• Owners
• Managers
• Supervisors
• Trainers
• Students
ACRONYMS
Aw -Water Activity
BFAD (now FDA) - Bureau of Food and Drug (Food and Drug Administration)
CAC - Codex Alimentarius Commission
CDC -Centers for Disease Control and Prevention
cGMP - Current Good Manufacturing Practices
EPA - Environmental Protection Agency
EC - European Community
EU - European Union
Eurep G.A.P - Euro-Retailer Produce Working Group (EUREP) Good Agricultural Practices
FAO - Food and Agriculture Organization
FATTOM - Food, Acidity, Temperature, Time, Oxygen, Moisture
FDA - Food and Drug Administration
FDC - Food, Drug and Cosmetic
FSIS - Food safety and Inspection Service
FSMS - Food Safety Management System
GFSI - Global Food Safety Initiative
Global G.A.P. - Global Good Agricultural Practices
GLP - Good Laboratory Practices
GMP - Good Manufacturing Practices
GRAS - Generally Recognized As Safe
HACCP - Hazard Analysis Critical Control Point
ISO - International Organization for Standardization
PAS - Publicly Available Standard
PPE - Personnel Protective Equipment
PRP - Prerequisite Program
SQF - Safe Quality Food
SOP - Standard Operating Procedure
SSOP - Sanitation Standard Operating Procedure
WHO - World Health Organization
WTO - World Trade Organization
Introduction
Globalization brings an array of food selection from the supermarket shelves to our plates. It also raises
public concern over food safety scares. Whenever we select and consume food, we expect it to be safe
to eat. This expectation and consumer demand place important responsibilities on the people who work
with food. It is thus of prime importance for the food workers to know how to protect the food from
hazards that might cause injury or illness to the consumers.
This GMP course introduces the participants to the basic principles of food safety, hygiene and
sanitation. It discusses the food safety hazards and how to adequately control them. This course lays the
foundation where the other food safety management systems build upon.
Learning objectives:
In the U.S., the Centers for Disease Control and Prevention (CDC) is the federal agency that is
responsible for protecting public health through the prevention and control of diseases. The CDC
supports foodborne disease investigation and prepares annual summaries and statistics on outbreaks of
foodborne diseases including all those transmitted through food and water.
Quiz 1.
1. Ask the students to share knowledge on foodborne illnesses and share the foodborne illness
outbreaks that they know or have experienced
2. How can we control foodborne illness as producer, as teacher, as consumer?
Emphasize that foodborne illnesses are preventable and that every stakeholder has a significant role in
preventing foodborne illnesses.
Suggested Readings:
• Codex Alimentarius Commission, 2001. Codex Alimentarius Food hygiene Basic Texts. Food
and Agricultural Organization of the United Nations, World Health Organization, Rome.
• ISO 22000: 2005 Food safety management system
• Regenstein, J.M., and Regenstein C.T. 1979. An introduction to the Kosher dietary laws of food
scientists and food processors. Food Technol. (Chicago). 33(1): 89-99
• Jones, J.M. 1992. Food safety. Eagan Press, St. Paul Minnesota, U.S. A.
• www.fda.gov/fsma
• Drexler, J. M. 2011. Schuster Institute for Investigative Journalism at Brandeis University,
Watthan, MA.
• http://www.bfad.gov.
• http://spatterson3.blogs.plymouth.edu/2012/11/26/how-safe-is-your-food...
• http://www.lifetimefitnessnutrition.com/healthy-foods.html. better-regulations-not-fancy-
kitchen-tools-are-the-key-to-food-safety/259673/
• www.foodsafetynews.com
Session 2: Food Safety Hazards and Control Measures
Learning objectives:
Workshop 1.
Workshop objectives:
1. To train participants how to evaluate their operations and be able to identify possible food safety
hazards
2. For the participants to suggest ways of controlling the identified food safety hazards in their
operations
Workshop procedure:
Assign different products per team according to the products that are important to them such as their
own products or any major product of interest in the area.
Trainer needs to review and comment on the workshop outputs per group. Emphasize that knowledge of
the raw materials, process and finished product specifications relating to food safety is very important
during hazard analysis. If they know the hazards, they can establish control measures to address the
hazards.
1. Group the participants into 3 groups and have each group prepare a list of chemical, physical and
microbiological hazards that may be associated with identified products.
2. Identify source and control measures that may reduce or eliminate these hazard
• Food and Drug Administration. 2009. 2009 Food Code . United Sates Public Health
Service. Washington, DC.
• McSwane, D. N. R. Rue, and R. Linton. 2005. Essentials of Food Safety. Pearson, Prentice
Hall. pp.440
• Codex General Standards for the labelling of Prepackaged Foods, Section 4.2.1.4 Codex
Stan – 1 1985 as amended
• http://www.inspection.gc.ca/english/fssa/invenq/inform/allerge.shtml.
• http://www.mhlw.go.jp/english/topics/qa/allergies/al.html.
• Food Standards Agency. 2005. Draft- Guidance on all allergen control and consumer
information
• Loken, J.K. 1995. The HACCP Food safety Manual. John Wiley & Sons. New York.
pp318
Session 3: Introduction to food safety frameworks relating to GMP (PRP)
Time: 10 min
Learning objectives:
Review Notes:
Difference between Statutory and Regulatory Requirements
Statutory Requirements are the body of laws created by legislative statutes. Statutory refers to laws
passed by national government, e.g. Regulation (EC) 178/2002, PD 856, Republic Act No. 9003. The
national and local regulatory agencies that are responsible for enforcing food and safety requirements
are usually under the departments of health, environment, and agriculture. Statutory requirements are
legally mandated requirements that must be compiled with by the organization to which it applies.
Regulatory means a rule issued by an agency that the government has given authority to regulate an
industry. Examples: A.O.153 issued by Philippine FDA, Discharge Permit issued by LLDA . “
Regulatory" is limited by an authoritative group e.g. the EPA saying you can only allow a certain
amount of emissions to escape the workplace.
US Food Laws
Federal Food, Drug and Cosmetic (FD & C) Act
The FDA administers the federal Food, Drug and Cosmetic Act 22 which was originally passed by
Congress in 1938 to ensure that foods are safe, pure, wholesome, and produced under sanitary
conditions. Several amendments have been added to the law since then. Among them are Miler
Pesticide Amendment of 1954, the Food Additives Amendment of 1958 and the Color Additives
Amendment of 1960.
The Miller Pesticide Amendment 23 establishes a procedure for the setting of safe amounts (tolerances)
for residues of pesticides which may remain on fresh fruits, vegetables, and other raw agricultural
commodities when shipped in interstate commerce.
The 1958 Food Additives Amendment has a 2-fold purpose: (1). To protect the public health by
requiring proof of safety before substance may be added to food; and (2) to advance food technology
and improve the food supply by permitting the use of substances which are safe at the levels of intended
use. Currently there’s a list of over 3,000 approved food additives. Excluded are those food additives
which have been designated as GRAS, generally recognized as safe substances.
Discussion Points:
1. Ask the participants especially the manufacturers the permits and licenses required in their
operation and their products.
2. What are their regulated raw materials and products?
Emphasize the need for compliance to legal and regulatory requirements locally and those of the export
customers. There should be a system to monitor compliance.
Quiz 3.
1. Example of regulatory standards
a. Permit to Operate or License to Operate
b. Workers Health Certificate
c. Product Registration
d. All of the above
e. None of the above
2. Government agencies involve in food safety regulation in Cambodia
a. Ministry of Health
b. Ministry of Commerce
c. Ministry of Industry and Handicraft
d. All of the above
e. None of the above
3. When exporting,
a. The exporting company should know the food safety regulations and requirements of the
exporting country
b. The exporting company should know the food safety regulations and statutory requirements
of the importing and exporting country
c. The exporting company should know the food safety regulations and requirements of the
importing country
d. Only a is correct
e. None of the above
4. What are the food safety frameworks that are applicable to food manufacturers?
a. HACCP
b. ISO 22000
c. FSSC 22000
d. GMP
e. All of the above
5. Who in the organization should know the food safety regulations and statutory requirements?
a. HACCP team only
b. HACCP Team, Top Management and key employees
c. Employees only
d. Consultant
e. c and d
Suggested Readings:
• Codex Alimentarius Commission, 2001. Codex Alimentarius Food hygiene Basic Texts. Food
and Agricultural Organization of the United Nations, World Health Organization, Rome.
• http://gain.fas.usda.gov/Food and Agricultural Import Regulations and Standards. 2007.
Philippines FAIRS Country Report.
Session 4: GMP: Introduction
Time: 10 min
Learning objectives:
By the end of this session, the participants should:
Know what GMP is
Know the functions of prerequisite programs (PRP)
be clear on food safety terms and definitions
Refer to Slides # 99 to 110
Review Notes:
Good Manufacturing Practices (GMP) is a collection of generally recognized rules, procedures and
practices that provide a code stating what is acceptable and what is not acceptable in the food industry to
ensure production of quality and safe foods.
Companies usually develop procedures and are usually termed SOP or Standard Operating Procedures
Per Codex Alimentarius, the following are the scope of GMP/GHP:
Primary Production
Design and Facilities
Control of Operation
Maintenance and Sanitation
Personal Hygiene
Transportation
Product Information and Consumer Awareness
Training
In food safety management systems such as HACCP and ISO 22000, GMP is one of the prerequisite
programs. PRP are food safety basic conditions and activities that are necessary to maintain a hygienic
environment throughout the food chain suitable for the production, handling and provision of safe end
products and safe food for human consumption
The PRPs depend on the segment of the food chain in which the organization operates and the type of
organization
PAS (Publicly Available Specification) focuses on the prerequisite program (PRP) elements & sets out
detailed requirements similar to GMP. The organization is required to pass each element within an FSSC
22000:2010 audit. There are specific PAS standards that are applicable to specific sectors of the food
chain:
ISO/TS 22002-1 (formerly Pas 220) - Applicable to food manufacturers
PAS 223:2011 - Applicable to food packaging manufacturers
PAS 221:2013 - Applicable to food retailers
Discussion Points:
1. What are the important and basic food safety standards?
2. Why are these standards important?
3. What are their existing procedures, guidelines and policies in connection with GMP
requirements? Give examples.
4. Do you know of companies that are implementing GMP?
Emphasize the importance of establishing GMP procedures in a food establishment in maintaining
hygiene and sanitation. These are basic requirements to ensure hygienic operations in the manufacture,
handling and storage of food products.
Emphasize globalization and the need to comply to compete.
Quiz 4.
1. Coverage of GMP
a. Pest Control
b. Hygiene and sanitation
c. Training
d. Cleaning and Sanitation
e. All of the above
2. Standard applicable to food packaging operations
a. ISO 22000
b. ISO/TS 22002-1
c. PAS 223
d. All of the above
e. a & c
3. Which of the following standard is a prerequisite program of HACCP and ISO 22000?
a. 5S
b. Lean manufacturing
c. GMP
d. ISO 9001
e. None of the above
4. Which of the following standard is applicable to the members of the food chain?
a. ISO 22000
b. FSSC 22000
c. GMP
d. HACCP
e. All of the above
5. Who should know about the food safety standards’ requirements in varying extent?
a. Employees only
b. Top management only
c. HACCP Team only
d. HACCP Team leader only
e. All of the above
Suggested Readings:
• www.fda.gov/Food/FoodSafety/RetailFoodProtection/FoodCode/FoodCode2005/ index.htm
• PAS 220:2008. Prerequisite programmes on food safety for food manufacturing.
• Food Development Center. 2009. Requirements for Good Manufacturing Practice in the
Handling and Processing of Foods.
• Chartered Institute of Environmental Health. 2000. Food safety management
• Codex Alimentarius 2003. Recommended International code of practice- General principles of
food hygiene
• McSwane, D. , N. R. Rue, and R.Linton. 2005. Food Safety and Sanitation. 4 th edition
• www.ada.gov/cguide .htm .
• Gorham, R.S.(Ed.) 1985. Principles of Food Analysis for Filth. Decomposition and Foreign
Matter. FDA. Technical bulletin 1. pp22-25: 50-57 and pp 178-179. Arlington, Virginia:
Association of Official Analytical Chemists, Inc.
• Gonzales, J. Jr. 1986. Pest control management in a frozen food warehouse. Lecture delivered
at the seminar on Culture. Processing and Quality Control of Shrimps for Export. FTI.,
Taguig, Metro Manila (September 2-,4, 1986).
• www. fda.gov.ph
Session 5: Primary Production
Time: 10 min
Learning objectives:
Discussion Points:
1. Give examples of primary producers
2. What is the importance of GMP in primary production?
3. Give examples of hazards associated with primary products?
Emphasize that there are food safety hazards that can originate from primary products. In vegetable and
fruit production – e.g. GMO issue, pesticide residue, aflatoxin, biological hazards coming from soil. In
animal production – dioxin, antibiotic residues, GMO issue, Salmonella, etc… In marine sector- virus,
histamine, inherent toxins in seafoods, among others.
Emphasize that if there are no tests results or COA coming from primary producers, it is the
responsibility of the next user such as the feed producers, chicken dressing plants, food manufacturers to
have the raw materials coming from primary producers to have them tested for contents of the identified
hazards.
Quiz 5.
1. Examples of food safety hazards for fruits and vegetables:
a. Salmonella
b. Pesticide residue
c. Aflatoxin
d. Antibiotic residues
e. a, b and c
2. Examples of food safety hazards in fresh marine products
a. Dioxine
b. Aflatoxin
c. Molds
d. Viruses and bacteria
e. A and d
3. Examples of food safety hazards in animal products
a. Bacteria and viruses
b. Antibiotic residues
c. Pesticide residues
d. Growth hormone residues
e. a, b & d
4. Not a requirements for primary production
a. Hygiene and sanitation
b. Site selection
c. Laboratory gown for field workers
d. Training
e. Proper Waste disposal
5. Primary producers are considered _____ to food manufacturers
a. Third party
b. Suppliers
c. No relationship
d. Customers
e. None of the above
Session 6: Establishment: Design and Facilities
Time: 15 min
Learning objectives:
By the end of this session, the participants should be able to:
Know the requirements of location
State the requirements of premises and rooms
State the requirements of equipment
State the requirements of facilities
Activity: Workshop 2
Time: 20 min
Resources Needed: Flip Charts/manila paper/A0 paper, markers, masking tape
2. List all the items in the food manufacturing operations that require PM and Calibration
Time: 15 min
Resources Needed: Flip Charts/manila paper/A0 paper, markers, masking tape
Calibration Program
Area/Location Item/Equipmen Frequenc Interna Externa Responsibilit Records
t to be y and l l y
Maintained Schedule
Quiz 6.
1. Coving is :
a. Curved sealed edge between the floor and the wall that eliminates sharp corners to make
cleaning easier
b. Anti-slip floor covering used to protect workers from slips and falls
c. Plastic material used to seal cracks and crevices under and around equipment in a food
establishment
d. Device used to prevent back siphonage
e. None of the above
Learning objectives:
By the end of this session, the participants should be able to:
State the control of food hazards
Know the key aspects of hygiene control systems
State Incoming material requirements
Know the requirements on packaging
Know the requirements for water
Define the requirements on management and supervision
B. Plant Schematic
A plant schematic must be developed to show product flow and employee traffic
patterns within the plant for the specific product.
- the diagram should include the flow of all ingredients and packaging materials
from the moment they are received at he plant, through storage, preparation,
processing, packaging, finished product holding ad shipping.
- The personnel flow should indicate employee movement through the plant, including changing
room, toilets and lunchroom. The location of handwashing facilities and food baths (if
applicable) should be noted.
Time: 30 minutes
Team Presentation and discussion: 30 min
Suggested Readings:
• Food and Drug Administration. 2009. 2009 Food Code. United Sates Public Health Service.
Washington, DC.
• McSwane, D. N. R. Rue, and R. Linton. 2005. Essentials of Food Safety. Pearson, Prentice Hall.
pp.440
• Chartered Institute of Environmental Health. 2000. Food Safety Management. Chadwick House
Group Limited.
• Codex General Standards for the labelling of Prepackaged Foods, Section 4.2.1.4 Codex Stan –
1– 1985 as amended
• http://www.inspection.gc.ca/english/fssa/invenq/inform/allerge.shtml.
• http://www.mhlw.go.jp/english/topics/qa/allergies/al.html.
• Food Standards Agency. 2005. Draft- Guidance on all allergen control and consumer
information.
Quiz 7.
1. Physical contamination can be controlled by the following except:
a. Swab test
b. Magnet
c. Metal detector
d. Screen and sieves
e. Visual Inspection
2. Chemical contaminants can best be detected through:
a. Microbiological test
b. Chemical tests
c. Screens and sieves
d. X-ray
e. Sensory evaluation ( by tasting, smelling, touching, visual inspection)
3. Biological contaminants can best be detected by:
a. Microbiological tests
b. Chemical tests
c. Screens and sieves
d. X-ray
e. Sensory evaluation ( by tasting, smelling, touching, visual inspection)
4. Biological contaminants can be controlled by:
a. Time and temperature management
b. Metal detector
c. Visual inspection
d. Smelling
e. Chemical testing
5. Management of incoming materials
a. Inspection
b. Verify accompanying COA
c. Storage in required warehouse
d. All of the above
e. None of the above
Session 8: Establishment: Maintenance and Sanitation
Time: 30 min
Learning objectives:
By the end of this session, the participants should be able to learn about:
Maintenance and sanitation
Pest control systems
Waste management
Monitoring effectiveness
Refer to Slides # 171 to 187
Workshop 4: Writing SSOPS
Time: 30 min
Resources Needed: Flip Charts/manila paper/A0 paper, markers, masking tape
Objective of the Workshop:
To let the participants know the procedures that need to be written and implemented so that
sanitation and prevention of cross-contamination be assured for critical areas in the food
manufacturing plant.
To let the participants realize the resources that are needed in order to implement the procedures
effectively
Trainer needs to review and comment on the workshop outputs per group. Emphasize the need to
monitor compliance to procedures through verification, inspection and testing.
Learning objectives:
Discussion Points
1. Ask the participants to enumerate the different procedures on personal hygiene such as in hiring
workers, production, visitors
2. What are the resource requirements for personal hygiene?
Emphasize the importance of proper handwashing. Also discuss on management’s provision of proper
facilities, training to use the facilities, use of facilities by the employees.
Emphasize on consistency of employees – Personal hygiene required for managers, employees, visitors
and contractors who are entering the critical areas in the food establishment.
Quiz 9.
1. The most effective method of preventing cross contamination
a. Taking a bath
b. Proper Handwashing
c. Drying
d. All of the above ‘
e. None of the above
2. Food handlers infected with the following illness should not be permitted to work in the food
processing area:
a. Jaundice, Diarrhoea
b. Vomitting, Discharges from ear, eye or nose
c. Fever ,Sore throat with fever
d. Visibly infected skin lesions (boils, cuts,
e. All of the above
3. Handwashing should be done
a. Anytime
b. 3 times a day
c. Whenever you feel like washing
d. None of the above
e. Whenever your hands get dirty
4. Personal hygiene includes good behavior appropriate inside the food processing area such as:
a. No spitting
b. No eating
c. No smoking
d. All of the above
e. None of the above
5. Visitors should also:
a. Follow GMP procedures
b. Wear appropriate PPEs
c. Be excused from following GMP procedures
d. Observe appropriate behavior inside the establishment
e. a,b & d
Session 10: Transportation
Time: 10 min
Learning objective:
Discussion Points:
1. Ask the participants to state the requirements for transporting food products.
Emphasize that the same hygienic handling and conditions must be provided to the products when they
are produced stored and transported.
Emphasize on the training of the truckers and delivery crew on food safety
Emphasize that transport or delivery is the extension of the manufacturing facility and that the same care
on handling should be given to the products being delivered.
Quiz 10.
1. In transporting food products, observe:
a. Cleanliness of the truck
b. Temperature requirement
c. Stacking height
d. Allowed product mix
e. All of the above
2. Requirements for bulk containers and conveyances:
a. Do not contaminate foods or packaging
b. can be effectively cleaned and disinfected, if necessary
c. Permit effective separation of different foods or foods from non-food items (where
necessary) during transport;
d. Effective protection from contamination, including dust and fumes;
e. All of the above
3. Containers used for transporting should:
a. Be used for whatever types of chemicals
b. Be used for toxic chemicals and just washed before loading
c. Be cleaned and inspected prior to loading
d. All of the above
e. None of the above
4. In transporting rice for export, the following are required:
a. Refrigerated
b. Freezer temperature can be attained
c. Fumigation can be done, if needed
d. Relative humidity should be observed
e. All of the above
5. In transporting our produce, we need to train the following:
a. Loading crew
b. Truckers
c. Warehousemen
d. QC inspectors
e. All of the above
Session 11: Product Information and Consumer Awareness
Time: 10 min
Learning objectives:
Discussion Points:
1. Ask the participants to look at a sample label of a product and enumerate the information about
the product that is given to the consumers/users.
2. Why is labelling important?
Emphasize on the responsibility of the users/consumers to read and follow food safety instructions.
Quiz 11.
1. Important contents of a food label:
a. Product name
b. Manufacturer’s name
c. Lot number; manufacturing date
d. All of the above
e. None of the above
Learning objectives:
Discussion Points:
Learning objective:
By the end of this session, the participants should be able to:
Understand the importance of documenting specifications for raw materials, packaging materials
and finished goods
Refer to Slides # 222 to 233
Discussion Points:
1. Review participants on the contents of specifications
2. What is the importance of specifications?
Stress the point that the food safety information on the raw materials, equipment, finished goods,
process and regulatory requirements need to be available during hazard analysis
4. Specifications:
a. Are documents that need to be updated
b. Are considered records
c. Are not necessary
d. Need not be filed
e. All of the above
Learning objectives:
By the end of this session, the participants should be able to:
Appreciate consultancy and training
Have capacity to do consultancy and training
Consider going into consultancy and training
ANNEXES: