Competency Based Learning Material: S: P F & B Q: F P NC Ii U C: I G M P P M T: I G M P P

COMPETENCY BASED LEARNING MATERIAL
SECTOR : PROCESSED FOODS & BEVERAEGES
QUALIFICATION : FOOD PROCESSING NC II
UNIT OF COMPETENCY : IMPLEMENT GOOD MANUFACTURING PRACTICE

PROCEDURE
MODULE TITLE : IMPLEMENTING GOOD MANUFACTURING PRACTICE

PROCEDURE
HOW TO USE THIS COMPETENCY-BASED LEARNING MATERIAL
The unit of competency, “Implement Good Manufacturing Practice

Procedure”, is one of the competencies of FOOD PROCESSING NC II, a course which
comprises the knowledge, skills, and attitudes required for a TVET trainee to
possess.
The module, Implementing Good Manufacturing Practice Procedure,

covers the knowledge, skills and attitude required in researching general information
on food and beverage cocktails, and sharing in.
In this module, you are required to go through a series of learning activities in

order to complete each learning outcome. In each learning outcome are Information
Sheets, Self-checks, Operation Sheets, Task Sheets, and Job Sheets. Follow and
perform the activities on your own. If you have questions, do not hesitate to ask for
assistance from your facilitator.
Remember to:
 Read information sheet and complete the self-checks.

 Perform the Task Sheets, Operation Sheets, and Job Sheets until you are
confident that your outputs conform to the Performance Criteria Checklists
that follow the said work sheets.
 Submit outputs of the Task Sheets, Operation Sheets, and Job Sheets to your
facilitator for evaluation and recording in the Achievement Chart. Outputs shall
serve as your portfolio during the Institutional Competency Evaluation. When
you feel confident that you have had sufficient practice, ask your trainer to
evaluate you. The results of your assessment will be recorded in your
Achievement Chart and Progress Chart.
You must pass the Institutional Competency Evaluation for this competency
before moving to another competency. A Certificate of Achievement will be awarded
to you after passing the evaluation.
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FOOD PROCESSING NNC II WORLD - CLASS
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CBLM ON IMPLEMENTING GOOD WORLD - CLASS
MANUFACTURING PRACTICE TECHNICAL
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QA System PROCEDURE INSTITUTE
FOOD PROCESSING NC II
COMPETENCY BASED LEARNING MATERIALS
LIST OF COMMON UNITS OF COMPETENCIES
No. Unit of Competency Module Title Code
1 Apply Food Safety and Applying Food Safety and PFB751210

Sanitation Sanitation
2 Use Standard Measuring Using Standard Measuring PFB751211

Devices / Instruments Devices / Instruments
3 Use Food Processing Tools, Using Food Processing PFB751212

Equipment and Utensils Tools, Equipment and
Utensils
4 Perform Mathematical Performing Mathematical PFB751213

Computation Computation
5 Implement Good Implementing Good PFB751214

Manufacturing Practice Manufacturing Practice
Procedure Procedure
6 Implement Environmental Implementing Environmental PFB751215

Policies and Procedures Policies and Procedures
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MODULE CONTENT
UNIT OF COMPETENCY : Implement Good Manufacturing Practice

Procedure
MODULE TITLE : Implementing Good Manufacturing Practice

Procedure
MODULE DESCRIPTOR : This unit covers the knowledge, skills and

attitudes required to comply with relevant Good
Manufacturing Practice (GMP) codes through
the implementation of workplace GMP and
quality procedures
NOMINAL DURATION :
At the end of this module, you MUST be able to:

LO1 - Identify requirements of GMP related to own work
LO2 - Observe personal hygiene and conduct to meet GMP requirements
LO3 - Implement GMP requirements when carrying out work activities
LO4- Participate in improving GMP
LO5 - Participate in validation processes
LO6 - Complete workplace documentation to support GMP
ASSESSMENT CRITERIA
LO1 - Identify requirements of GMP related to own work
 Sources of information on GMP requirements are located
 GMP requirements and responsibilities related to own work are identified
LO2 - Observe personal hygiene and conduct to meet GMP requirements

 Personal hygiene meets GMP requirements
 Clothing is prepared, used, stored and disposed of according to GMP and
workplace procedures
 Personal movement around the workplace complies with area entry and exit
procedures
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LO3 - Implement GMP requirements when carrying out work activities
 GMP requirements are identified
 Work area, materials, equipment and product are routinely monitored to
ensure compliance with GMP requirements
 Raw materials, packaging components and product are handled according
to GMP and workplace procedures
 Workplace procedures to control resource allocation and process are
followed to meet GMP requirements
 Common forms of contamination are identified and appropriate control
measures are followed according to GMP requirements
 The workplace is maintained in a clean and tidy order to meet GMP
housekeeping standard
LO4- Participate in improving GMP

 Processes, practices or conditions which could result in non-compliance
with GMP are identified and reported according to workplace reporting
requirements
 Corrective action is implemented within level of responsibility
 GMP issues are raised with designated personnel
LO5 - Participate in validation processes

 Validation procedures are followed to GMP requirements
 Issues arising from validation are raised with designated personnel
 Validation procedures are documented to meet GMP requirements
LO6 - Complete workplace documentation to support GMP

 Documentation and recording requirements are identified
 Information is recorded according to workplace reporting procedures to
meet GMP requirements
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LEARNING OUTCOME # 1 Identify requirements of GMP related to
own work
CONTENTS:
1. Good Manufacturing Practices
ASSESMENT CRITERIA:
 Sources of information on GMP requirements are located
 GMP requirements and responsibilities related to own work are identified
CONDITIONS:
The trainee / student must be provided with the following:
 Workplace location and access to workplace policies
 Materials relevant to the proposed activity and tasks
ASSESSMENT METHODS:
Competency in this unit may be assessed through:
 Interview/questions
 Practical demonstration
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Learning Experiences
Learning Outcome # 1 - Identify requirements of GMP related to own work
Learning Activities Special Instructions
Read Information Sheet 5.1-1 Read and understand the information sheet
Good Manufacturing Practices and check yourself by answering the self-
Answer Self-Check 5.1-1 check. You must answer all the questions
(Trainee checks answers against correctly before proceedings to the next
the answer key) activity
Refer to Task sheets, it will help you practice

your skills.
The performance criteria checklist will guide

and help you evaluate your work as you are
practicing your skills.
Evaluate your own performance using the

performance criteria checklist. When you are
ready, present your work to your trainer for
final evaluation and recording.
If you have questions and clarification fell free

to ask your trainer
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Information Sheet 5.1-1
Good Manufacturing Practices
Introduction
GMP (Good Manufacturing Practices) establishes the operational conditions and
requirements necessary to ensure hygiene throughout the food chain and for the
production thereof.
5 Main Components of GMP
GMP is a complex manufacturing system designed to ensure all products—including

medical devices and pharmaceuticals—are produced and controlled in line with
specific quality standards.
These practices cover all aspects of the manufacturing process, with the goal of
mitigating (and ideally preventing) risks such as cross-contamination, mislabeling,
failure, and other potentially-catastrophic problems. Areas that play an active role in
the GMP guideline include:
 Sanitation and hygiene.
 Building, facilities, and equipment.
 Raw materials.
 Quality management.
 Personnel.
 Complaints.
 Documentation and recordkeeping.
 Validation and qualification.
 Inspections and GMP audits.
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By focusing on the above areas, manufacturers can work toward GMP compliance.
Good Manufacturing Practices require that products are:
 Of consistent quality.
 Designed for their intended use.
 Able to meet the marketing authorization and/or clinical trial authorization.
The benefits of GMP are expansive. Implementing Good Manufacturing Practices

can help to:
 Reduce waste.
 Increase productivity and profitability
 Reduce the risk of recalls, compliance issues, and other problems.
GMP can help protect both Life Sciences companies and customers. The
overarching goal is to guarantee quality throughout the manufacturing process. All
manufacturers who wish to sell their products in the European Union (EU) and/or in
the United States must comply with the GMP.
GMP vs. cGMP
You might be familiar with both GMP (Good Manufacturing Practices)

and cGMP (current Good Manufacturing Practices). In most cases, these terms
mean the same thing and are virtually interchangeable.
GMP is the basic U.S. Food & Drug Administration (FDA) regulation set forth under
the Federal Food, Drug, and Cosmetic Act to make sure manufacturers are being
proactive in developing safe and effective products.
cGMP, however, was implemented to promote the continuous improvement of

product quality. The idea here is that manufacturers stay committed to the highest
possible quality standards by keeping their systems and technologies up-to-date.
It’s important to note that while cGMP regulations feature a number of practices
focusing on multiple manufacturing phases (and on several aspects of quality), these
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are just the minimum requirements organizations have already implemented in their
quality assurance and risk management processes.
So what, exactly, does compliance entail? Which regulatory bodies oversee these
standards? The next section will provide an overview of the specifics surrounding
GMP compliance.
Good Manufacturing Process Regulations
The cGMP regulation—written in accordance with FDA guidelines—helps to ensure

the strength, quality, and purity of Life Sciences companies’ products.
Per the regulation, manufacturers must regularly inspect their processes, implement
consistent quality management systems, and source the appropriate quality of raw
materials. In addition, companies need to detect and investigate any product
deviations, maintain reliable equipment and facilities, and adhere to well-
documented management and manufacturing procedures.
While the FDA oversees cGMP regulations in the U.S., the European Medicines
Agency (EMA) conducts GMP inspections in Europe. EMA is the regulatory body
responsible for GMP activities at the EU level. The agency is involved in facilitating
GMP cooperation among member states and in ensuring the common interpretation
of all GMP requirements.
These requirements include prioritizing and harmonizing the five main components
of GMP.
5 Main Components of GMP
GMP features five main components. Manufacturers might think of them as the “Five
P’s.” These include the following:
1. Products
The primary materials (or raw ingredients) used to create a medical device or other
relevant solution need to be of the highest quality. GMP standards reveal that all
products must follow a specific master formula free from deviations throughout the
manufacturing process. A quality assurance system featuring regular testing and
constant comparisons is imperative—complete with clear specifications at every
production phase.
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2. People
Hiring well-qualified people will encourage GMP compliance as well. So will training
these workers in proper sanitation, recordkeeping, labeling, and equipment handling.
Though training is an investment, it can make all the difference from a quality
assurance perspective. All team members must strictly follow manufacturing
regulations, with each individual fulfilling a specific role. Regular performance
assessments and frequent evaluations will elevate competency.
3. Processes
All manufacturing processes must be followed—and documented—to the strictest

standard. Since auditors regularly inspect laboratories and other facilities for
consistency and quality, documentation is truly essential. Manufacturers can take
this a step further by keeping a written framework of the entire manufacturing
process and distributing these materials to all team members. Here too, frequent
evaluations are key from a compliance standpoint.
4. Procedures
Processes and procedures go hand in hand. A procedure is a series of guidelines

needed to perform a process (with the goal of generating a specific result). During
audits, manufacturing procedures are highly scrutinized. If any procedure is using
outdated technology, the manufacturer will risk facing noncompliance penalties.
Procedural consistency can help mitigate this. Employees should fully understand
the procedures they must follow.
5. Premises
All facilities, laboratories, and equipment should be maintained to guarantee safe,

sanitary, and effective manufacturing conditions. This includes proper cleaning and
storage, along with any other measures that can be taken to achieve consistent
results, lower the risk of equipment failure, and ensure timely repairs. Reducing
product variations is the end goal here, as is protecting patients, customers, and
team members from operational issues onsite.
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GMP Compliance
How can Life Sciences companies ensure GMP compliance? In addition to

embracing the five components of GMP, a focus on the steps below can bring clarity:
 Write all procedures professionally in a clear tone using specific language.
 Clean and maintain all equipment per the manufacturer’s instructions and
standards.
 Audit your organization’s compliance at least once each month.
 Complete a comprehensive competence analysis before hiring new team

members.
Taking these measures will help companies in the Life Sciences fully embrace the
Five P’s of GMP.
Principles of GMP
Before we conclude this article, consider the following overview of the main
principles of GMP:
 Creation of Standard Operating Procedures (SOPs).
 Enforcement of SOPs and work instructions.
 Documentation of all procedures and processes.
 Validation of the effectiveness of SOPs.
 Design and use of working systems.
 Development of worker competencies.
 Maintenance of systems, equipment, and facilities.
 Prevention of contamination through high cleanliness standards.
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 Prioritization of quality in the design, development, and manufacturing
workflow.
IMPORTANCE OF GOOD MANUFACTURING PRACTICES IN FOOD INDUSTRY
Consumers put a great deal of trust in the manufacturers who make the products
they use daily, like medicines, car parts, cosmetics, and food. When products have
to be recalled, this can cast doubt in the minds of consumers, which is why
prevention is so important. Here's what you need to know.
Manufacturers need to do everything they can to foster the trust they are given, and
take the necessary steps to keep it. One way to do that is by implementing Good
Manufacturing Practices (GMP).
WHAT ARE GOOD MANUFACTURING PRACTICES?
Good Manufacturing Practices (GMP) is a system that ensures that the goods
produced by various manufacturing facilities are consistently produced and
controlled according to specified quality standards. There are GMP systems for
everything from cosmetics to pharmaceutical products to, of course, food.
GMP looks at every aspect of the manufacturing process to guard against potential
risks that can prove detrimental to the products being produced. Cross-
contamination, mislabeling, and adulteration are just a few of the things GMP aims
to prevent.
The FDA regulates the Current Good Manufacturing Practices (CGMP), and
therefore requires companies to abide by their specified guidelines. They are
considered "Current" because, as new information is discovered, the Good
Manufacturing Practices released by the government will change to reflect the new
finding(s).
These Practices are made to be flexible, to better allow companies to adjust them to
fit their specific needs. However, to meet the GMP and CGMP guidelines, certain
areas still have to be met accordingly.
WHY ARE THEY IMPORTANT?
Good Manufacturing Practices are a critical system that all manufacturing facilities
should implement. They help ensure the proper design, monitoring, and control of
the manufacturing processes and facilities. Companies that adhere to these
standards help to assure the identity, strength, and quality of their products. When
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implemented, GMP can help to cut down on facility losses and waste and also help
to protect the company, consumer, and the environment from harm.
The Current Good Manufacturing Practices are set by the FDA and give
manufacturers across all industries a set of standards to strive for. They help
facilities earn and maintain the trust of consumers who want to know the products
they buy are manufactured in safe, well-regulated environments, and to government
standards.
Good Manufacturing Practices in food industry manufacturers are especially vital

these days, due to the increasing number of food recalls occurring. Consumers
have become increasingly aware of food safety and expect companies to take steps
to increase their accountability, and provide them with safe products that will not get
recalled.
WHAT GOES INTO GOOD MANUFACTURING PRACTICES IN FOOD

INDUSTRY MANUFACTURERS?
There are a number of things in the GMP of food industries and manufacturing
industries in general. In some cases, if the FDA's guidelines aren't met, it can result
in severe legal penalties.
1. QUALITY MANAGEMENT
Quality management is a principle that focuses on ensuring that manufactured

products are fit for their intended use. For food, this means ensuring that the food
meets the FDA's food safety and quality measures. So, there should be no raw,
expired, or improperly processed products that can potentially harm consumers or
cause contamination.
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2. SANITATION AND HYGIENE
In terms of Good Manufacturing Practices, there is nothing more vital than sanitation
and hygiene, particularly for drug, cosmetic, and food manufacturers. This covers
anything that can lead to contamination, if proper hygiene and sanitation is not
practiced. One step a facility can take to ensure proper sanitation and hygiene is to
install a food-grade stainless Slot Drain drainage system. Slot Drain is a grate-free
in floor drain that is resistant to things like extreme temperatures, corrosion, and
bacteria. It comes pre-sloped and pre-assembled, making it easy to install and
maintain, and it is an ideal addition to manufacturing facilities.
3. SUITABLE FACILITY LOCATIONS
The FDA's Current Good Manufacturing Practices state that manufacturing facilities
should be in a suitable location, free from the risk of any contamination. Additionally,
the facility should be designed to help minimize the risk of potential errors in
operations and should be easy to clean and maintain.
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4. EQUIPMENT
Similar to the location requirements, any equipment within the facility should be
designed, located, and maintained to function as intended. All equipment should
also be regularly cleaned and stored according to the proper procedures, and
removed if found defective or malfunctioning.
5. RAW MATERIALS
Any materials for production are required to be stored appropriately. Furthermore, a

proper inventory of the raw materials the facility has in stock should be available
and updated regularly, as well as documentation of where the materials come from,
to ensure quality.
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6. PERSONNEL
Naturally, successful GMP compliance relies heavily on facility personnel. Everyone

who works for the facility should be well-trained and qualified to do their assigned
job. They should have a clear awareness of the various GMP principles and receive
continual training, so they are always up-to-date with their job skills and what is
expected by the FDA.
7. VALIDATION AND QUALIFICATION
The critical steps of the manufacturing process should be validated to ensure they
meet specific GMP qualification guidelines. Regular reviews of this process will also
help to ensure that product quality remains high and consistent.
8. HANDLE COMPLAINTS
Another key factor of Good Manufacturing Practices includes handling complaints.

All companies and facilities should have a GMP-compliant system for handling
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complaints. The ideal complaint system should include prepared solutions for all
contingencies within the facility.
9. DOCUMENTATION AND RECORDKEEPING
Keeping thorough records is an essential part of any company, and therefore a

critical part of the GMP. Everything about the facility should be documented in clear,
legible ways. All documents should be kept in an organized system where
managers can easily find and refer to various aspects of the facility at any time.
10. INSPECTIONS AND QUALITY AUDITS
Another step that goes into Good Manufacturing Practices in all facilities are
inspections and quality audits. By regularly conducting inspections and audits,
facilities can ensure that they are properly complying with the GMP. These checks
will also help to keep the facility from forgetting to follow the guidelines; otherwise,
they will be hit with serious consequences.
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COMPLYING WITH GMP
Now you know about Good Manufacturing Practices and why they are essential.
Regardless of the type of manufacturing facility, GMP is a critical part of running a
high-quality facility. By being GMP compliant, facilities make a strong effort to create
a safe, high-quality, and sanitary environment to create safe and high-quality
products for consumers. They are standards to strive for, particularly for facilities
producing products that people consume, like pharmaceuticals and, of course, food.
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Self-Check 5.1-1
Check your mastery in interpretation of plans and details by completing the
tasks below.
FILL IN THE BLANK:
1. ________________ establishes the operational conditions and requirements

necessary to ensure hygiene throughout the food chain and for the production
thereof.
2. ____________ was implemented to promote the continuous improvement of

product quality.
3. A ____________ featuring regular testing and constant comparisons is

imperative—complete with clear specifications at every production phase.
4. Though ________ is an investment, it can make all the difference from a

quality assurance perspective.
5. A __________ is a series of guidelines needed to perform a process (with the

goal of generating a specific result).
6. _____________ is a principle that focuses on ensuring that manufactured

products are fit for their intended use.
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Answer key 5.1-1
Check your answer with the answer key below. if you fail to get it right, refer
back to corresponding resources until you make it perfect.
1. GMP (Good Manufacturing Practices)

2. cGMP
3. quality assurance system
4. training
5. procedure
6. Quality management
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LEARNING OUTCOME # 2 Observe personal hygiene and conduct to
CONTENTS:
1. Personal hygiene in GMP
ASSESMENT CRITERIA:
o Personal hygiene meets GMP requirements
o Clothing is prepared, used, stored and disposed of according to GMP
and workplace procedures
o Personal movement around the workplace complies with area entry
and exit procedures
CONDITIONS:
ASSESSMENT METHODS:
 Oral examination
 Written examination
 Performance test
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Learning Outcome # 2 – Observe personal hygiene and conduct to meet GMP
requirements
Read Information Sheet 5.2-1 on Read and understand the information sheet
Personal hygiene in GMP and check yourself by answering the self-

your skills.



to ask your trainer
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Personal hygiene in GMP
Introduction
A person regularly works in the production area of a pharmaceutical company, but

today he is not allowed to work there as he has an open lesion in his arm. He
informed to his supervisor regarding his injury and he shifted him to other area where
GMP is not practiced. So, what was wrong with him? Why he was not permitted to
work in GMP area? What does GMP include and why it is important to follow?
GMP (Good Manufacturing Practice) is a part of a quality system which covers

manufacturing and testing of active pharmaceutical ingredients, pharmaceutical
dosage forms or drugs, diagnostics, foods, pharmaceutical products, and medical
devices. GMP ensures that products are produced consistently and controlled as per
the quality standards appropriate to their intended use and as required by the
marketing authorization.
Personal hygiene is very important aspect of GMP. All personnel working in the
production area are expected to maintain a high degree of personal cleanliness.
Physical hygiene includes the human hazards and hygiene, head-hair, nose, mouth,
eyes, ears, makeup, cosmetics and jewelry, coverings and clothing and gloves. Here
listed the few Do’s and Don’ts of GMP with respect to personal hygiene:
 Medical examination: Every employee must undergo medical examination

including eye examination especially for those who are responsible for visual
inspection of drug products. All employees working under GMP must be free
from tuberculosis, skin and other communicable or contagious disease and
must have medical examination at least once a year and their records should
be maintained properly. Employees should be trained in practices which
ensure personal hygiene. If there is any apparent illness or open lesions,
supervisors must be informed immediately and person should not be allowed
to handle starting material, packaging material, in-process materials or drug
products as it may cause the microbial contamination in drug product.
 Direct contact should be avoided between operator’s hand and starting

material, primary packaging materials and intermediate or bulk product.
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 To ensure the protection of the product from contamination, personnel should
wear clean body coverings appropriate to the duties they perform, including
appropriate hair covering. The protective clothing must be changed daily and
when necessary within a day. All soiled laundry must be placed in the
receptacles provided and should not be left in the production area.
 Nails should be clean and trimmed and use of nail polish is prohibited in the
production area as it may flake off and contaminate the product. Persons
working in production area must wear the protective hair net and no hair
should be exposed or protrude from under a hair net. Men with mustaches
and beard must cover them fully with beard net. Jwelery, including watches
are not allowed and must be removed before entering the plant.
 Hands must be free of any lesions, wounds, cuts, boils, or any other sources
of infection. Hands must be washed with soap before starting work, after
break time, after lunch, after using washroom, after blowing nose, after
handling garbage or whenever your hands become contaminated. Wash
hands before putting a new pair of gloves and change gloves at every break,
when torn or after touching garbage and after touching your face and blowing
nose. All used gloves must be disposed in the garbage cans provided.
 Smoking, eating, drinking, chewing and keeping plants, food, drink, smoking
material and personal medicines should not be permitted in production,
laboratory and storage areas.
Personal hygiene procedures including the use of protective clothing should apply to
all persons entering production areas, whether they are temporary or full-time
employees or non-employees, e.g. contractors’ employees, visitors, senior managers
and inspectors.
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Self-Check 5.2-1
tasks below.
FILL IN THE BLANK:
1. __________ is very important aspect of GMP.
2. All personnel working in the production area are expected to maintain a high
degree of __________.
3. Physical hygiene includes the _________ and hygiene, head-hair, nose,

mouth, eyes, ears, makeup, cosmetics and jewelry, coverings and clothing
and gloves.
4. _________ should be avoided between operator’s hand and starting material,

primary packaging materials and intermediate or bulk product.
5. __________ must be free of any lesions, wounds, cuts, boils, or any other
sources of infection.
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Answer key 5.2-1
1. Personal hygiene
2. personal cleanliness
3. human hazards
4. Direct contact
5. Hands
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LEARNING OUTCOME # 3 Implement GMP requirements when carrying
out work activities
CONTENTS:
1. Good Working Practice – Facilities and Equipment’s
ASSESMENT CRITERIA:
 GMP requirements are identified
 Work area, materials, equipment and product are routinely monitored to
ensure compliance with GMP requirements
 Raw materials, packaging components and product are handled according
to GMP and workplace procedures
 Workplace procedures to control resource allocation and process are
followed to meet GMP requirements
 Common forms of contamination are identified and appropriate control
measures are followed according to GMP requirements
 The workplace is maintained in a clean and tidy order to meet GMP
housekeeping standard
CONDITIONS:
ASSESSMENT METHODS:
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Learning Outcome # 3 – Implement GMP requirements when carrying out work
activities
Good Working Practice – Facilities and check yourself by answering the self-
and Equipment’s check. You must answer all the questions
Answer Self-Check 5.3-1 correctly before proceedings to the next
(Trainee checks answers against activity
the answer key)
your skills.



to ask your trainer
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Good Working Practice – Facilities and Equipment’s
Introduction
Product Contact Equipment, both Major and Minor, used in production, Subdivision,
or sampling of a drug product, In-Process Material, or Raw Material (RM) shall be
cleaned and shall include, and not be limited to:
 Changeover Cleaning;
 Interval Cleaning during a Campaign, as necessary; or
 Dedicated Equipment Cleaning at the end of a campaign. Equipment
disassembly may be required to clean or to Verify cleanliness.
Equipment Cleaning for major equipment must be conducted following written

Instruction-Records or Standard Operating Procedures (SOP) with an attached
checklist(s). These documents shall be Approved by the Site Production Team and
Site Quality Team before being issued.
Equipment cleaning for minor equipment shall be conducted following written SOPs
or Instructions-Records and these cleaning activities must be documented. The
SOPs and Instruction-Records shall be approved by the Site Production Team and
the Site Quality Team before being issued.
Executed Instruction-Records or checklist used shall be reviewed and approved by

the Site Quality Team. Use and Cleaning History must be determined for product
contact equipment that has been used by third parties or by another facility (e.g.,
trials, rentals, borrowed). The history must be documented and approved by the Site
Quality Team. The removal of previous product residues must be verified, prior to
any use.
The history shall demonstrate that the equipment was not used for and does not
contain potential contamination from objectionable materials (e.g., penicillins or other
beta lactams, pesticides).
Equipment Cleaning shall be designed to prevent Cross Contamination including

microbiological contamination, when applicable [based on the Risk Assessment, by
reducing residues on all product contact surfaces to acceptable levels. Maximum
Allowable Residue (MAR) and Residue Acceptability Limit (RAL) for Equipment
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Cleaning shall be established by Qualified personnel based on the empirical data
and the approved calculation method, prior to any use.
Swab or Rinsate Sampling Methods must be Validated through use of recovery

studies. The Analytical Methods used to test for residue must also be validated. For
Changeover Cleaning, Routine Verification of Cleaning Processes for Major
Equipment Where One Hundred (100) Percent Visual Inspection is not Possible shall
include:
 Inspection to the extent practical to verify the equipment is Visibly Clean;

 Periodic monitoring (e.g., using swab or rinsate sampling method as per
validation) at a frequency defined based on a documented and approved risk
assessment (e.g., up to 2 to 3 years) of the probability of contamination; and
 Approved justification of the rationale for the frequency of the periodic
monitoring.
Routine Verification of Cleaning Processes for Major Equipment Where One

Hundred (100) Percent Visual Inspection is Possible shall include inspection to verify
the equipment is visibly clean (e.g., mills, filter housings, and tray driers).
After Completion of any Maintenance or Instrument Calibration Activities that

required opening or disassembly of equipment, an evaluation must be conducted
and documented to determine the level of cleaning required, if any, for product
contact equipment.
Prior to Being Put into Service, New Equipment shall be cleaned and, the equipment
shall be verified as visually clean at a minimum. The cleaning and verification of
cleanliness must be documented and approved prior to use.
Equipment Cleaning Failures During Routine Monitoring (i.e., visual and/or analytical
result failures) must be documented and Investigated according to established Site
procedures. An evaluation of the impact on validation must be included.
Identification of Equipment Areas and Processes
Distinctive Equipment Identification Numbers or Codes shall be displayed clearly and

prominently on all Areas and Major Equipment that involve, or are directly related to
Production, and shall be used for referring to that equipment in all such documents
as manufacturing, packaging, cleaning, and maintenance Instruction-Records, and in
corresponding equipment logs and other similar records.
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All Rooms and Areas Used for Production shall be identified at all times by function
(e.g., filling room, blending room, packaging area, crystallizer room) and/or room
number.
During Processing, Materials, Processing Vessels, Major Equipment, and Rooms

that are involved in the process must be labeled or otherwise clearly identified
(e.g.,barcodes, Computerized Systems) with an indication of the product or material
being processed including, and not limited to the following information:
 Name of the product or material being processed;

 Strength, if applicable;
 Batch Number or Lot Number;and
 Stage of production (e.g., crystallization, drying, blending, filling), when
applicable.
Processing and/or Storage Vessels and their associated manifolds, filling, and
discharge lines shall be identified in a manner designed to preclude incorrect use of
the lines.
Fixed and/or Dedicated Processing Lines, Piping, and Other Conveying Devices that
provide liquids or gases to production or control areas shall be clearly identified as to
the contents and the direction of flow in a manner designed to preclude incorrect use
of the lines.
 All identification from the prior product has been removed;

 The cleaning records are complete; and
 If applicable, analytical results are satisfactory.
For equipment cleaning procedures that require validation, the Site Quality Team
must approve the executed cleaning records prior to the disposition of any batch of
the next campaign.
– Maximum Allowable Time Intervals between use and initiation of cleaning shall
be specified, unless there is an approved documented rationale or data
demonstrating the time interval is non-critical. These intervals shall include
consideration of the variables that could affect cleaning.
– After Completion of any Maintenance or Instrument Calibration Activities that
required opening or disassembly of product contact equipment; an evaluation
must be conducted and documented to determine the level of cleaning required,
if any.
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– Failures During Routine Monitoring (i.e., visual and/or analytical result failures)
following changeover cleaning must be documented and Investigated according
to established Site SOPs. An evaluation of the impact on validation must be
included.
– Prior to Being Put into Service, New Major Product Contact Equipment shall be
cleaned and verified as visually clean at a minimum. The cleaning and verification
of cleanliness must be documented. All new product contact equipment (major
and minor) must be visually inspected, if possible, prior to service to ensure that
no debris or residue remains. Site Quality Team shall approve the approach to
cleaning and verification of new major product contact equipment at the Site.
Calibration
This section of practice document establishes the requirements for the Calibration of
equipment, instruments, and standards used in Production, storage and testing that
may affect the identity, strength, quality, or purity of Pharmaceutical or Animal Health
Drug Products, Active Pharmaceutical Ingredients (API),and Medical Devices.
This document applies to all GMP sites and operations and Logistics Centres
responsible for production, control, and distribution of Pharmaceutical and Animal
Health drug products, API and medical devices.
Calibration Program(s) shall be established and maintained in all gmp sites defining
the responsibilities, criteria, and documentation requirements for the calibration of
equipment and instruments used at that Site.
The Site Quality Team and the System Owner shall be notified of such events. The
documentation shall include Impact Assessments on Batches or Lots produced using
the system and associated components under investigation. The System Owner
shall:
 Investigate additional PM work performed beyond that which is detailed on the

individual PM instructions (i.e., PM Work Order);
 Initiate a deviation report if the investigation determines that there is potential
impact to product quality; and
 Review and document the Verification that the PM was completed prior to
returning the systems and associated components back into service.
Defective Systems and Associated Components shall be removed from the
location of use (e.g., Production Area), if possible, or at a minimum,
designated as defective and out-of-service.
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PM Records shall be current and readily retrievable and shall be maintained in
accordance with the Site record retention SOPs
Computerized Systems used to schedule or track PM, and/or to maintain PM records

must be validated. Equipment Documentation (i.e., System Cleaning, Maintenance,
and Use Records) resulting from PM shall be recorded.
PM Activities shall be performed and maintained by Qualified personnel. Records of

training shall be maintained.
On-Site PM Performed by Qualified Contractors or Vendors shall comply with this

document.
Cleaning and Sterilization of Aseptic Manufacturing Equipment
Equipment Used in Aseptic Processing shall be designed to minimize the risk of

particulate and microbiological contamination. Design considerations for such
equipment shall include, and are not limited to, the following:
 Sanitary fittings for all pipe and hose connections;

 Materials of construction that allow repeated cleaning and Disinfection
treatments;
 Avoidance of crevices, occluded surfaces, and hard to clean areas;
 Product contact surfaces resistant to rusting, pitting, corrosion, and peeling;
and
 Ease of assembly and disassembly.
This practice document applies to all GMP sites and operations where Sterile Active
Pharmaceutical Ingredients (API), sterile Drug Products, and sterile Medical Devices
are produced for Pharmaceutical and Animal Health.
Equipment Used in the Manufacture, Holding, Sampling, and Processing of sterile

APIs, sterile drug products and aseptically processed sterile medical devices shall be
cleaned and sterilized following written and Approved Standard Operating
Procedures (SOP) and a Validated Process.
– Sterile Equipment shall be delivered to the Aseptic Processing Area (APA) in a

manner designed to prevent contamination, such as through double-sided Batch
sterilizers or Airlocks.
– The Maximum Time Interval Between Washing and Sterilization of equipment
must be established and validated if the equipment is not stored under protected
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conditions. The maximum time interval between sterilization and use of
equipment shall be validated.
– Measures to Differentiate sterile equipment from non-sterile equipment shall be
defined. Examples of these measures include:
o Supplier identification of sterile items;
o Sterilization indicators;
o Facility design (e.g., material flow patterns); and
o SOPs for handling equipment before and after sterilization (e.g., material
separation).
– Each Carrier (e.g., Cart, Basket, Tray, or Plastic Bag with Breather Panel) of
Equipment and Individually Wrapped Equipment readied for sterilization shall be
identified (e.g., with a non-shedding label such as Tyvek or metal tag) with the
following information:
o Identification of person preparing the equipment for sterilization;
o Description of the equipment or item;
o Sterilizer identification;
o Specified sterilization cycle identification;
o Date of sterilization; and
o Expiration Date.
– Wrapped Equipment Sterilized in a Batch Sterilizer shall be unloaded and stored
in an environment with the applicable air classification for a period of time not to
exceed the maximum specified validated time interval.
– Sterilized Equipment shall be visually inspected for damage to the wrapping prior
to storage or use. Damaged packages shall be labeled as damaged and removed
from the APA
– Equipment Cleaning and Sterilization shall be documented and included in
batch /Lot Records
Areas and Facilities Cleaning and Maintenance
This section of practice document defines the cleaning and maintenance of GMP
facilities (e.g., rooms/areas, modules) used in the Production, Sampling, or
Subdivision of Drug Product Raw Materials (RM), Intermediates (postintroduction of
the API Starting Material), drug product In-Process Materials, Active Pharmaceutical
Ingredients (API), drug products, Packaging Materials, Biologics, or Medical Devices.
Such areas or facilities shall be cleaned and maintained in ways that:
- Ensure personnel safety;
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Self-Check 5.3-1
tasks below.
FILL IN THE BLANK:
1. ____________ for major equipment must be conducted following written

Instruction-Records or Standard Operating Procedures (SOP) with an
attached checklist(s).
2. Equipment Cleaning shall be designed to prevent __________
3. _____________ and _____________ for Equipment Cleaning shall be

established by Qualified personnel based on the empirical data and the
approved calculation method, prior to any use.
4. ___________ Sampling Methods must be Validated through use of recovery

studies.
5. Equipment Used in __________ shall be designed to minimize the risk of

particulate and microbiological contamination.
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Answer key 5.3-1
1. Equipment Cleaning
2. Cross Contamination
3. Maximum Allowable Residue (MAR) ; Residue Acceptability Limit (RAL
4. Swab or Rinsate
5. Aseptic Processing
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LEARNING OUTCOME # 4 Participate in improving GMP
CONTENTS:
1. Corrective action
ASSESMENT CRITERIA:
 Processes, practices or conditions which could result in non-compliance
with GMP are identified and reported according to workplace reporting
requirements
 Corrective action is implemented within level of responsibility
 GMP issues are raised with designated personnel
CONDITIONS:
ASSESSMENT METHODS:
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Learning Outcome # 4 – Participate in improving GMP
Read Information Sheet 5.4-1 Read and understand the information sheet
Corrective action and check yourself by answering the self-

your skills.



to ask your trainer
Document No.
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Corrective action
Introduction
Corrective action is an immediate and intended step taken to address non-

compliance of allowable critical limits at any operation. This operation is
performed within a reasonable time frame in an attempt to return the breached
parameters to acceptable limits. In the food industry, non-compliance and
deviations in critical limits may mean that the risk of causing foodborne
illnesses will significantly increase. Corrective action can be a simple step, such
as recalibrating a piece of equipment to highly technical operations that involve
recomputing for alternative working parameters.
In a food establishment, including other industries, corrective action must be

established in anticipation of any potential non-compliance. This step does not mean
that employees can relax with their food handling practices because appropriate
corrective actions are in place. The application of corrective action can cause an
increase in material and labor costs. Sometimes, corrective action can land on a
decision to dispose of non-compliant products to protect the consumers from
damages.
What is corrective action in the workplace?
Particularly in a food industry workplace, a corrective action process can be any

operation performed to control the critical limit back to an acceptable level. An
example of a food processing establishment would be cooking meat to the
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correct internal temperature. Critical limits for the internal cooking temperature of
meat such as for chicken are set to ensure that the dominant microbiological
pathogen is properly removed.
For chicken, the target temperature is 165°F (74°C). Temperatures significantly

below this target temperature, such as 160°F (71°C), could enable target pathogens
to survive. As such, corrective actions must be applied. The appropriate corrective
action process to this hazard is to reprocess the product for a shorter time using
gentle heating. If this corrective action is not applicable, products can be disposed of
based on the decision from the corrective action plan.
For common corrective actions outside the context of the HACCP system, simple
operations such as mandating employees to file a sick leave when not feeling well
can be an important corrective action. Additionally, other operations such as
providing better protection gear for employees are effective corrective actions.
What is a HACCP corrective action plan?
A corrective action plan is an outline of steps needed to resolve errors or non-

compliance. In terms of the HACCP principles, a corrective action plan is
created in preparation for any deviations from established critical limits. This
plan is created to prevent hazardous foods from reaching potential customers and
causing foodborne illnesses or customer complaints.
A corrective action plan is an essential part of your HACCP plan. It is your food
business team's defense in case of uncommon deviations. As such, your team
must be able to fulfill all steps to ensure an effective corrective action plan.
In any other industry, a corrective action plan employs having SMART goals. This
acronym describes the desirable qualities of an effective corrective action plan.
 Specific
 Measurable
 Attainable
 Relevant
 Time-based
In a HACCP plan, corrective actions are dependent on the identified critical

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control points and their corresponding critical limits. Conducting corrective action
must always be monitored for corrective action reports. This step produces review
records that can serve as proof that the products are either safe, or a just cause was
identified to dispose of them. In addition, particular metrics are established to identify
whether a corrective action plan is successful in containing deviations.
To monitor the application of this operation, a HACCP corrective action plan

template such as the one shown below from the Food and Drug Administration must
always be prepared.
At what point in a HACCP plan should corrective actions be identified?
HACCP corrective actions are established for every critical control point and its
critical limits. A HACCP corrective action plan is made particularly for specific
operations. They are designed to control potential deviations on a food safety
task and, therefore, must be related to a critical control point operation.
Under this principle, the following are identified for a corrective action plan:
 Corrective action step
 Assigned employee to perform corrective action
 Appropriate corrective action documentation
Members of your HACCP team who are well-versed with the HACCP plan, the
process, and the nature of the product are the most ideal candidates to perform a
corrective action procedure. Once corrective actions are applied, the expertise of the
food safety manager must be sought to collect a corrective action decision for the
products affected by the deviation.
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Corrective action and Preventive action (CAPA)
Apart from the corrective actions applied in the fifth principle of the HACCP system,
a different system called the Corrective and Preventive action or CAPA system
exists. The CAPA process is used to address issues at any part of your food
business management controls including:
 Production and process controls
 Service reports
 Equipment and facility
 Materials
 Design
 Records, documents, and change controls
The main objective of a CAPA process is to collect and analyze information

and to predict and foresee food safety and quality management to establish
actions that can prevent or control them from occurring. Remember that
correction and preventive action procedures are two different operations. They are
applied in different sections of the operating system but are equally
important. Appropriate monitoring techniques and verification procedures must
always be implemented together with these actions.
A CAPA process consists of three different operations, (1) correction, (2)

corrective action, and (3) preventive action procedures. Although these may
seem all similar, these operations are very distinct. Here is a summary of their
differences.

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Based on the Quality Management System Regulation FDA 21 CFR 820 in the

United States, it is a regulatory requirement for manufacturers to establish
procedures for corrective and preventive actions. The CAPA is a system under
the prerequisite program Good Manufacturing Practices and contributes to the
effectiveness of a HACCP plan.
How to write a corrective action plan?
A corrective action plan is used to resolve systemic problems and any core issue. As
such, it tries to target the root cause of potential problems. An important essence of
corrective action steps is the foresight of potential industry issues. Sufficient and
reliable details are major keys to making an effective corrective action plan.
If it is your first time making a corrective action program, it would be best to take
things slowly and use this step-by-step instruction. Each step is important to
make the plan effective.
A corrective action guide consists of these major steps:
1. Identify all deviations from critical limits. To understand the appropriate

action, sufficient information on the problem must be collected. Questions
such as "What is the problem at hand?" and " How did the problem occur?"
must be appropriately answered for proper assessment. At this point, the
assigned employee can determine if the problem is a problem with quality
standards or a safety issue.
2. Appropriate corrective actions to resolve non-compliance. Whether a

product quality or a safety issue, the problem must be immediately dealt with.
Especially in the food manufacturing company where products are sometimes
produced by the second, immediate corrective action must be applied to
prevent the problem from causing a bigger effect. Corrective actions must
always be justifiable, measurable, and can be applied in real-time to ensure
their applicability at any point in food processing.
3. Determine the cause of deviation. In contrast with correction, a corrective

action involves determining the root cause of the deviation. Through this, the
recurrence of the problem can be prevented. At this point, a comprehensive
root cause analysis and data gathering from an objective investigation must
be conducted. Questions such as "What led to the problem from occurring?"
may be asked to assess the situation. Remember that the lack of proper
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information can lead to an inefficient corrective action plan where the
problems may still recur.
4. Decide on a disposition for the non-compliant food products. For

manufacturing companies, non-compliant products, although applied with
corrective actions, can be insufficient for the company compliance standards.
As such, dispositions such as whether to rework, reconstitute, or dispose of
these must be made. In deciding what to do with non-compliant food products,
the safety of consumers must always come first.
5. Validation methods for the effectiveness of the corrective action and

record. To ensure that the corrective actions have been properly applied and
that their purpose has been achieved, validation methods must be in place.
These records serve as proof and reference if complaints on the affected
products arise. Additionally, they can also be significant tools for traceability
purposes.
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Self-Check 5.4-1
tasks below.
FILL IN THE BLANK:
1. ___________ is an immediate and intended step taken to address non-compliance of

allowable critical limits at any operation.
2. In the food industry, non-compliance and deviations in critical limits may mean that
the risk of causing __________ will significantly increase.
3. In a food establishment, including other industries, corrective action must be

established in anticipation of any ____________.
4. An example of a food processing establishment would be cooking meat to the correct

_______________.
5. ____________ for the internal cooking temperature of meat such as for chicken are
set to ensure that the dominant microbiological pathogen is properly removed.
6. A _______________ is an outline of steps needed to resolve errors or non-

compliance.
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Answer key 5.4-1
1. Corrective action
2. foodborne illnesses
3. potential non-compliance
4. internal temperature
5. Critical limits
6. corrective action plan
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LEARNING OUTCOME # 5 Participate in validation processes
CONTENTS:
1. Validate GMP and Prerequisite Programs
ASSESMENT CRITERIA:
 Validation procedures are followed to GMP requirements
 Issues arising from validation are raised with designated personnel
 Validation procedures are documented to meet GMP requirements
CONDITIONS:
ASSESSMENT METHODS:
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Learning Outcome # 5– Participate in validation processes
Validate GMP and Prerequisite and check yourself by answering the self-
Programs check. You must answer all the questions
Answer Self-Check 5.5-1 correctly before proceedings to the next
(Trainee checks answers against activity
the answer key)
your skills.



to ask your trainer
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Validate GMP and Prerequisite Programs
Introduction
If a pyramid can theoretically represent a plant’s overall food safety system, then
Hazard Analysis and Critical Control Points (HACCP) plans are the tip of that
pyramid. It is through HACCP plan development that the investigation of food safety
occurs. This science-based system outlines the methods by which hazards are
reduced or eliminated. When microbial
hazards are identified in a product or a
production process, a critical control
point (CCP) may be identified or
established to reduce or eliminate the
hazards. Critical control points require
that the processing parameters are
determined. The food safety
professional’s ability to prove the efficacy
work each department performs for a
safe food product implemented benefit
the entire company, from the foundation
up.
While HACCP is the investigation of

hazards, the foundation and bulk of the
food safety pyramid is represented by
day-to-day employee activities that constitute Good Manufacturing Practices (GMPs)
and prerequisite programs (Figure 1). If HACCP plan CCPs are scientifically proven
effective through scientific studies, GMPs and prerequisite programs, in turn, are
scientifically proven to be effective by environmental monitoring programs (EMPs).
Environmental monitoring is the scientific justification to management, auditors,
clients and employees that the time, money and efforts put forth for uniforms, traffic
patterns, hand washing, cleaning, sanitation, sanitary equipment design and supplier
monitoring are effective (Table 1). The food safety professional’s ability to prove the
efficacy of the sanitation systems benefits the entire food safety program—from the
foundation up.
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Four Steps to a Great EMP
Environmental monitoring programs have multiple purposes, including:
 To assess if surface cleaning and sanitizing programs are effective to a

microbial level
 To determine if implemented GMPs and prerequisite programs are effective at
reducing or eliminating cross-contamination
 To assess equipment/utensils for harborage sites
 To assess cleaning frequency needed
The EMP assessment is not a short-term endeavor. It can take up to two years to
gather and trend the necessary data to develop a comprehensive plan. It is important
to put together a plan that can be implemented in phases to help assess the data as
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it is gathered (See “Make the Data Count”). Here are four simple steps that
correspond to the four purposes of an EMP—a sure-fire recipe for a highly practical
approach to ensuring the sanitary condition of your food processing plant.
Step 1: Assess if cleaning and sanitation programs are effective to a microbial

level. Knowing whether your sanitation program is actually working efficiently—or
not—is critical to assuring safe food production. Sampling method and frequency,
test selection, failure rate, air sampling, sampling time and specifications are all
elements that should be included in an EMP—and considered in the first step of
program development.
Establish sponge sites. The concept of zone sampling, first put forward by Kraft
Foods, is widely used as a site development tool because it allows for environmental
monitoring to concentrate on the areas where product is most susceptible to cross-
contamination (product contact areas), to track product as it traverses through the
plant, and to understand where and how product cross-contamination may occur.
Here is a brief outline of the zones, which includes surfaces and equipment that
should be considered when selecting sampling sites:
Zone 1: The area in the plant where there are direct product contact surfaces
immediately after a microbial reduction step and before packaging. If there is no kill
step in the process, Zone 1 is the point at which the product is exposed to the plant
equipment until packaging.
 Conveyer belts
 Tubing
 Utensils
 Blenders
Zone 2: This zone comprises non-product contact areas that are adjacent to product
contact surfaces.
 Dead spots
 Lubricants
 Equipment framework supports
 Drip shields that may drip onto exposed product
 Panel/operator buttons
 Dust on overhead lights
 Phones
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 Weight control data input area
Zone 3: Non-product contact areas within the processing area that are removed or
far away from product contact surfaces but could result in cross-contamination.
 Floors
 Hoses
 Ventilation shafts
 Water line condensate
 Trolleys, forklifts, walk-alongs
 Trash cans
 Rubber seals around doors
 Walls and ceilings
 Pallets
 Under foot baths
 Drains
Zone 4: The farthest from the production area, this zone includes all non-product
contact surfaces outside the processing room.
 Cooler/freezer floors
 Floors in locker rooms
 Bathrooms
 Cafeteria/breakrooms
 Hallways
 Loading docks
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Sampling. To maintain budgets, take the greatest volume of samples within Zone 1
and the least in Zone 4. However, sample all zones within a monthly period.
Samples should initially be taken once per week for one month prior to cleaning to
assess baseline microbial load (Table 2).
Tests to conduct. Because they account for larger numbers of bacteria, coliform and
aerobic plate counts (APC) are more sensitive than analyses for specific pathogens.
For U.S. Department of Agriculture (USDA) regulated meat and poultry
plants, Listeria and Salmonella are to be done according to mandates. If pathogens
are analyzed, take sponges after cleaning and before sanitizing so that production
can commence prior to return of results. Two to four months after this testing has
begun, sample in the same locations immediately after cleaning. Samples should be
taken weekly if the production line is used every day, bi-weekly to monthly if the line
is only used intermittently.
Failure rate. Out-of-specification results are to be expected. The goal is to limit such

instances, and track data to establish failure rates and patterns. A reasonable goal
for a EMP program is a < 10 failure rate.
Air sampling. Along with zone sampling, air sampling in or surrounding processing

areas is to be included in the EMP. Yeast and mold plates (potato dextrose agar or
dichloran rose bengal chloramphenicol) are set out for 15 to 45 minutes. Air
samplers may also be used as an alternative means of monitoring air quality.
Time of sampling. Some samples must be taken during the cleaning process, which
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will most likely occur at night during non-production hours. There-fore, it is
recommended that cleaning or lab personnel be trained to conduct sampling.
Specifications. Cleaning and sanitizing must be be effective to a microbial level

leading to specifications of <10 colony forming units/sponge for coliforms and
aerobic plate count. If Listeria and Salmonella tests are conducted, negative results
are required (Table 1).
Step 2: Determine if implemented GMPs and prerequisite programs are

effective at reducing or eliminating cross-contamination. A food processing
operation can establish many proper GMPs and prerequisites but if the measures in
these best practices or protocols are not well-implemented the risk of microbial
contamination of the product increases dramatically. Step 2 in creating an effective
EMP involves setting specifications or baselines for indicator organisms and then
verifying them.
General guidelines. The EMP program data will determine if GMPs and prerequisite
programs are properly implemented during production. To allow for bacterial
accumulation during production, environmental samples should be taken at least
three to four hours after the start of production, and should be continued throughout
the shift. Later into a production run, samples should be taken and labeled in
sequence to determine spots of bacterial collection and concentration.
Set specifications/baseline. One to three months’ worth of sponge data will

determine a specification (baseline) for coliforms, aerobic plate counts, coagulase
positive Staphylococcus, Listeria and Salmonella. Coliform and coagulase positive
Staphylococcus results of <10 CFU/sponge are desired for Zone 1,
negative Listeria and Salmonella and varied CFU/sponge for APC depending on the
product (Table 1).
Dairies or fermentative products should not test for aerobic plate counts. Samples of
employees and heavy hand contact such as packaging areas are sponge sites for
coagulase positive. The CFU/sponge will be higher during production than after
cleaning and will vary from plant to plant.
Document No.
Date Developed:
Issued by:
October 2022
TECHNICAL INSTITUTE
Revision # 00
Verification of GMPs and Prerequisites. Once baseline values are understood,
deviations above baseline data will indicate a failure in the plant’s systems, such as
changes in traffic patterns, employees, and cleaning/sanitizing chemicals. Sampling
frequency should be increased when test data shows values above baselines
(Figure 2). In order to identify deviation points in the system, increase sampling
frequency and the number of sampling sites. GMPs and prerequisite programs can
then be reevaluated, retrained and re-implemented as necessary.
Step 3: Assess equipment/utensils for harborage sites. The trend toward

sanitary equipment design has helped sanitation crews in many processing plants to
more effectively clean and sanitize production lines and their components.
Equipment and utensils designed to be easy to clean to a microbiological level are
made of scratch- and damage-resistant, corrosion-proof materials. These features
help reduce the occurrence of niches and harborage points–welcome environments
for unwanted microbial contaminants. More often than not, however, food plants
operate using a percentage of older equipment and utensils that do not have the
benefit of sanitary design. Older equipment, production line components and utensils
that come into contact with food should be assessed routinely.
Sampling. Samples should be taken after cleaning and before sanitizing, when
equipment is disassembled to its furthest point. The opportunity arises to sample
sites within the equipment not normally sampled. Sampling these sites may point to
microbial harborage spots unseen by the eye. This requires sampling during the
cleaning process. Identified harborage sites can then be incorporated into the EMP
on a scheduled basis that will be determined by Step 4.
Document No.
Date Developed:
Issued by:
October 2022
TECHNICAL INSTITUTE
Revision # 00
Specifications. The APC, coliform, yeast and mold specifications are <10
CFU/sponge, and negative/sponge is required for Listeria and Salmonella (Table 1).
Step 4: Assess cleaning frequency needed. The implementation of an EMP may

lead to the restructuring of the sanitation and frequency of the cleaning program the
plant currently employs. If baseline data show small or no deviations in the days
between cleaning and sanitation, these schedules may be extended. Similarly,
baseline deviations may indicate the need for more frequent equipment cleaning and
sanitation, and/or breakdown.
Stepping Up Food Safety
A properly established environmental monitoring program will increase the

understanding of a processing facility’s food safety control systems and confirm that
procedures already in place are in fact effective in reducing the risk of microbial
contamination of product. Microbial analysis before and during production will
provide verification of plant practices, and the expenses associated with training and
quality programs will be justified by tracking results and trending data over time. The
EMP will create accountability for the facility in terms of employee training;
maintenance of effective sanitation programs; establishment of GMP and
prerequisite programs; reduction of existing or potential microorganism harborage
points; and justification of time, labor and costs of cleaning frequency. By using
these four steps to create a solid EMP, the food processor will build a very strong
foundation for HACCP excellence and step up the effectiveness of the total food
safety system.
Document No.
Date Developed:
Issued by:
October 2022
TECHNICAL INSTITUTE
Revision # 00
Self-Check 5.5-1
tasks below.
FILL IN THE BLANK:
1. If a pyramid can theoretically represent a plant’s overall food safety system,

then ___________ plans are the tip of that pyramid.
2. The ________ assessment is not a short-term endeavor.
3. __________ and frequency, test selection, failure rate, air sampling, sampling
time and specifications are all elements that should be included in an EMP—
and considered in the first step of program development.
4. Non-product contact areas within the processing area that are removed or far
away from product contact surfaces but could result in _________.
Document No.
Date Developed:
Issued by:
October 2022
TECHNICAL INSTITUTE
Revision # 00
Answer key 5.5-1
1. Hazard Analysis and Critical Control Points (HACCP

2. EMP
3. Sampling method
4. cross-contamination
Document No.
Date Developed:
Issued by:
October 2022
TECHNICAL INSTITUTE
Revision # 00
LEARNING OUTCOME # 6 Complete workplace documentation to
support GMP
CONTENTS:
1. GMP Documentation and Records
ASSESMENT CRITERIA:
 Documentation and recording requirements are identified
 Information is recorded according to workplace reporting procedures to
CONDITIONS:
ASSESSMENT METHODS:
Document No.
Date Developed:
Issued by:
October 2022
TECHNICAL INSTITUTE
Revision # 00
Learning Outcome # 6– Complete workplace documentation to support GMP
GMP Documentation and Records and check yourself by answering the self-

your skills.



to ask your trainer
Document No.
Date Developed:
Issued by:
October 2022
TECHNICAL INSTITUTE
Revision # 00
GMP Documentation and Records
Introduction
The management of each operational site is required to define responsibility for

origination, distribution, maintenance, change control, and archiving of all GMP
documentation and records used within one site’s department or unit.
Document owners are required to ensure that the documentation and record
systems for which they are responsible are specified in the form of detailed SOPs,
including all aspects of documentation and records management as described
above.
All associates have the responsibility to ensure that all GMP activities are performed
according to the official SOPs, any deviations in procedure are reported to their
supervisor and are adequately documented.
The local Quality Assurance unit has the responsibility to ensure via organisational
measures and auditing that GMP documentation and records systems used within
the Operational Unit are complete and comply with the relevant GMP requirements,
and that the requirements of the SOPs are followed.
Requirements for specific documents or record including ownership, content,

authorisation and change control procedures are described or cross referenced in
the Quality Modules which relate to the subject of the document.
General requirements, applicable to all documents are:
Good documentation constitutes an essential part of the quality assurance system.

Clearly written procedures prevent errors from spoken communication and clear
documentation permits tracing of activities performed.
Documents must be designed, prepared, reviewed and distributed with care. They
must comply with the relevant parts of the marketing authorization dossiers.
Documents must be approved, signet and dated by appropriate, competent and

authorised persons.
Document No.
Date Developed:
Issued by:
October 2022
TECHNICAL INSTITUTE
Revision # 00
Documents must have unambiguous contents: title, nature and purpose should be
clearly stated. They must be laid out in an orderly fashion and be easy to check.
Reproduce documents must be clear and legible.
Documents must be regularly reviewed and kept up-to-date. When a document has
been revised, systems must be operated to prevent inadvertent use of superseded
documents (e.g. only current documentation should be available for use).
Documents must not be hand-written, although where documents require the entry of
data, these entries may be made in clear legible handwriting, in a suitable indelible
medium (i.e. not pencil). Sufficient space must be provided for such entries.
Any correction made to a document or record must be signed or initialled and dated,
the correction must permit the reading of the original information. Where appropriate,
the reason for the correction must be recorded.
Record must be kept at the time each action is taken and in such a way that all
activities concerning the conduct of preclinical studies, clinical trials, and the
manufacture and control of products are traceable.
Storage of critical records (e.g., GMP relevant must be secure, with limited access
only for authorised persons. The storage location must ensure adequate protection
from loss, destruction or falsification, and from damage due to fire, water, etc.
Records which are critical to regulatory compliance, or to support essential business

activities can be duplicated on paper, microfilm or electronically, and stored in a
separate, secure location, in a separate building from the originals to mitigate the risk
of an accidental loss and consequent field actions
Date may be recorded by electromagnetic or photographic means, but detailed

procedures relating to the system in use must be available and the accuracy of the
records should be checked. If documentation in handled by electronic data
processing methods, only authorised persons should be able to enter or modify data
in the computer, access must be restricted by passwords or other means an entry of
critical data must be independently checked.
It is particularly important that, during the period of retention, the data can be
rendered legible within an appropriate period of time.
If data is modified, it must be traceable.
Document No.
Date Developed:
Issued by:
October 2022
TECHNICAL INSTITUTE
Revision # 00
Document No.
Date Developed:
Issued by:
October 2022
TECHNICAL INSTITUTE
Revision # 00
Self-Check 5.6-1
tasks below.
FILL IN THE BLANK:
1. _________ are required to ensure that the documentation and record systems
for which they are responsible are specified in the form of detailed SOPs
2. Good documentation constitutes an essential part of the ____________.
3. Documents must be approved, signet and dated by appropriate, competent

and ___________
4. Any correction made to a document or record must be signed or __________

and dated
5. It is particularly important that, during the period of retention, the data can be
rendered legible within an appropriate __________.
Document No.
Date Developed:
Issued by:
October 2022
TECHNICAL INSTITUTE
Revision # 00
Answer key 5.6-1
1. Document owners
2. quality assurance system.
3. authorised persons
4. initialled
5. period of time
Document No.
Date Developed:
Issued by:
October 2022
TECHNICAL INSTITUTE
Revision # 00

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COMPETENCY BASED LEARNING MATERIAL

SECTOR : PROCESSED FOODS & BEVERAEGES

QUALIFICATION : FOOD PROCESSING NC II

UNIT OF COMPETENCY : IMPLEMENT GOOD MANUFACTURING PRACTICE

MODULE TITLE : IMPLEMENTING GOOD MANUFACTURING PRACTICE

The unit of competency, “Implement Good Manufacturing Practice

The module, Implementing Good Manufacturing Practice Procedure,

In this module, you are required to go through a series of learning activities in

 Read information sheet and complete the self-checks.

LIST OF COMMON UNITS OF COMPETENCIES

No. Unit of Competency Module Title Code

1 Apply Food Safety and Applying Food Safety and PFB751210

2 Use Standard Measuring Using Standard Measuring PFB751211

3 Use Food Processing Tools, Using Food Processing PFB751212

4 Perform Mathematical Performing Mathematical PFB751213

5 Implement Good Implementing Good PFB751214

6 Implement Environmental Implementing Environmental PFB751215

UNIT OF COMPETENCY : Implement Good Manufacturing Practice

MODULE TITLE : Implementing Good Manufacturing Practice

MODULE DESCRIPTOR : This unit covers the knowledge, skills and

At the end of this module, you MUST be able to:

LO2 - Observe personal hygiene and conduct to meet GMP requirements

LO4- Participate in improving GMP

LO5 - Participate in validation processes

LO6 - Complete workplace documentation to support GMP

Refer to Task sheets, it will help you practice

The performance criteria checklist will guide

Evaluate your own performance using the

If you have questions and clarification fell free

5 Main Components of GMP

GMP is a complex manufacturing system designed to ensure all products—including

 Sanitation and hygiene.

 Building, facilities, and equipment.

 Documentation and recordkeeping.

 Validation and qualification.

 Inspections and GMP audits.

 Designed for their intended use.

 Able to meet the marketing authorization and/or clinical trial authorization.

The benefits of GMP are expansive. Implementing Good Manufacturing Practices

 Increase productivity and profitability

 Reduce the risk of recalls, compliance issues, and other problems.

You might be familiar with both GMP (Good Manufacturing Practices)

cGMP, however, was implemented to promote the continuous improvement of

Good Manufacturing Process Regulations

The cGMP regulation—written in accordance with FDA guidelines—helps to ensure

5 Main Components of GMP

All manufacturing processes must be followed—and documented—to the strictest

Processes and procedures go hand in hand. A procedure is a series of guidelines

All facilities, laboratories, and equipment should be maintained to guarantee safe,

How can Life Sciences companies ensure GMP compliance? In addition to

 Write all procedures professionally in a clear tone using specific language.

 Audit your organization’s compliance at least once each month.

 Complete a comprehensive competence analysis before hiring new team

 Creation of Standard Operating Procedures (SOPs).

 Enforcement of SOPs and work instructions.

 Documentation of all procedures and processes.

 Validation of the effectiveness of SOPs.

 Design and use of working systems.

 Development of worker competencies.

3. _ and _ for Equipment Cleaning shall be