GOOD MANUFACTURING PRACTICE

(GMP)
 HACCP SYSTEM
HACCP was developed in the 1960’s when NASA asked Pillsbury to
design and manufacture the first food for space flights

The growing concern about food safety from public health authorities, The
food Industry….

HACCP has become the globally recognized method to ensure food safety
GOOD MANUFACTURING PRACTICES (GMP) ARE:
Preventative measures to ensure food safety
The foundation on which to build a HACCP, Food safety
management system
The fundamental operational requirements necessary to enable a
food business to produce safe food.
You can control many of the potential hazards in a processing plant
busing standard set of principle and hygienic practices for the
manufacturing and handling of food.
These standard principles and practices are called Good
Manufacturing Practices(GMPs)
COMPONENTS GMPS
GMP helps to ensure the consistent quality and safety of products by focusing
attention on five key elements ( 5 p’s )

Premises
Processes
Products
Procedures ( papers works)
Peoples
 HAZARDS

Food Safety Hazard: Biological, Chemical or Physical agent in food with the
potential to cause an adverse health effect

Biological: Bacteria, Virus, yeasts, protozoa….

Chemical: pesticides, cleaning Chemical, residues

Physical: Stones, hair, Bidis, Cigarettes, Button, Nails, nuts, Jewelry and any rust materials
…
 WHY GMP?

Government requirement
Ensure quality and safe product
Reduce rejects/ recalls
Satisfy customers
Maintain manufacturing consistency
Company image and reputation
 GMP REQUIREMENTS

1. Get the facility design right form the start (Facility layout,
Environment , Equipment)
2.Validâtes processes (validation, Change control)
3.Write good procedure and follow them
4.Traceability
5.Personnel/ Competency
6.Perform regular audits
 FACILITY/ PRINCIPLE OF GMP
1. Construction and layout of buildings and associated utilities;
2. Layout of premises, including workspace and employee
facilities;
3. Supplies of air, water, energy and other utilities;
4. Supporting services, including waste and sewage disposal;
5. Suitability of equipment and its accessibility for cleaning,
maintenance and preventive maintenance;
6. Management of purchased materials;
7. Measures for the prevention of cross-contamination;
8. Cleaning and sanitizing;
9. Pest control;
10.Personnel hygiene
1.1. CONSTRUCTION AND LAYOUT OF
BUILDINGS
1.1.1. GENERAL REQUIREMENTS
Buildings shall be designed, constructed and maintained in a manner appropriate
to the nature of the processing operations to be carried out,
The food safety hazards associated with those operations and the potential sources of
contamination from the plant environs.
Buildings shall be of durable construction which presents no hazard to the product.
 1.1.2 ENVIRONMENT
Consideration shall be given to potential sources of contamination from the local
environment.
Food production should not be carried out in areas where potentially harmful
substances could enter the product.
The effectiveness of measures taken to protect against potential contaminants shall
be periodically reviewed
 1.1.3. LOCATIONS OF
ESTABLISHMENTS
The site boundaries shall be clearly identified.
Access to the site shall be controlled.
The site shall be maintained in good order. Vegetation shall be tended or removed.
Roads, yards and parking areas shall be drained to prevent standing water and shall be
maintained.
1.1.4. SITE SECURITY
1.2. LAYOUT OF PREMISES AND WORKSPACE
1.2.1 General requirements
Internal layouts shall be designed, constructed and maintained to facilitate good hygiene and
manufacturing practices.
The movement patterns of materials, products and people, and the layout of equipment, shall be
designed to protect against potential contamination sources.
1.2.2 INTERNAL DESIGN, LAYOUT
AND TRAFFIC PATTERNS
The building shall provide adequate space, with a logical flow of
materials, products and personnel, and physical separation of raw from
processed areas.

Openings intended for transfer of materials shall be designed to

minimize entry of foreign matter and pests
1.2.2 INTERNAL DESIGN, LAYOUT AND
TRAFFIC PATTERNS
1.1.3 LAYOUT OF PREMISES
AND WORKSPACE
1.1.4 INTERNAL STRUCTURES
AND FITTINGS
Process area walls and floors shall be washable or cleanable

Materials of construction shall be resistant to the cleaning system applied.

Wall floor junctions and corners shall be designed to facilitate cleaning.

It is recommended that wall floor junctions be rounded in processing areas.

In wet process areas, floors shall be sealed and drained. Drains shall be
trapped and covered.
1.1.4 INTERNAL STRUCTURES
AND FITTINGS
1.1.4 INTERNAL
STRUCTURES AND
FITTINGS
 1.1.5. LOCATION OF
EQUIPMENT
Equipment shall be located so as to
 facilitate good hygiene practices and monitoring.
 permit access for operation, cleaning and maintenance
1.1.6 LABORATORY FACILITIES
In-line and on-line test facilities shall be controlled to minimize risk of
product contamination.

Microbiology laboratories shall be designed, located and operated so

as to prevent contamination of people, plant and products.

They shall not open directly on to a production area

1.1.7 STORAGE OF FOOD, PACKAGING
MATERIALS, INGREDIENTS AND NON-FOOD
CHEMICALS
Facilities used to store food and food contact shall
 provide protection from dust, condensation, drains, waste and other sources of
contamination.
 dry and well ventilated.
 Monitoring and control of temperature and humidity

Materials shall be stored off the floor and with sufficient space between the material and the walls
to allow inspection and pest control activities to be carried out.

A separate, secure (locked or otherwise access controlled) storage area shall be provided for
cleaning materials, chemicals and other hazardous substances
1.1.7 STORAGE OF FOOD, PACKAGING
MATERIALS, INGREDIENTS AND NON-
FOOD CHEMICALS
1.2 UTILITIES —AIR,
WATER, ENERGY
Water 1.2.1
used as WATER SUPPLY
 a product ingredient or in contact with products,

 cleaning or applications where there is a risk of indirect product contact (e.g. jacketed vessels, heat
exchangers)
 shall meet specified quality and microbiological requirements relevant to the application.

 Where water supplies are chlorinated, checks shall ensure that the residual chlorine level at the point
of use remains within limits given in relevant specifications.

 Take measures(e.g. labeled) to prevent non-potable water refluxing into the potable system
1.2.2 BOILER CHEMICALS
Boiler chemicals, if used, shall be either:

a) Approved food additives which meet relevant additive specifications; or

b) Additives which have been approved by the relevant regulatory authority

as safe for use in water intended for human consumption.

Boiler chemicals shall be stored in a separate, secure (locked or otherwise access-

controlled) area when not in immediate use
 1.2.3 AIR QUALITY AND
VENTILATION

The organization shall establish requirements for filtration, humidity (RH%) and
microbiology of air used as an ingredient or for direct product contact.

Where temperature and/or humidity are deemed critical by the organization, a control
system shall be put in place and monitored.

Ventilation(natural or mechanical) shall be provided to remove excess or unwanted steam,

dust and odors, and to facilitate drying after wet cleaning
1.2.3 AIR QUALITY AND
VENTILATION
Room air supply quality shall be controlled to minimize risk from
airborne microbiological contamination.

Ventilation systems shall be designed and constructed such that air does
not flow from contaminated or raw areas to clean areas.

Specified air pressure differentials shall be maintained.

Exterior air intake ports shall be examined periodically for physical integrity.
1.2.4. COMPRESSED AIR AND
OTHER GASES
Compressed air, carbon dioxide, nitrogen and other gas systems used in
manufacturing and/or filling shall be constructed and maintained so as to prevent
contamination.

Gases intended for direct or incidental product contact (including those used for
transporting, blowing or drying materials, products or equipment) shall be from a
source approved for food contact use, filtered to remove dust, oil and water.

Where oil is used for compressors and there is potential for the air to come into
contact with the product, the oil used shall be food grade
1.2.4. LIGHTING
The lighting provided (natural or artificial) shall allow personnel to operate in a
hygienic manner.

The intensity of the lighting should be appropriate to the nature of the operation.

Light fixtures shall be protected to ensure that materials, product or equipment

are not contaminated in the case of breakages.
1.2.4. LIGHTING
1.3. WASTE DISPOSAL
Containers for waste and inedible or hazardous substances shall
be:
a) Clearly identified for their intended purpose;

b) Located in a designated area;

c) Constructed of impervious material which can be readily cleaned and

sanitized;

d) Closed when not in immediate use;

e) Locked where the waste may pose a risk to the product

 1.3. WASTE DISPOSAL
Don’t accumulate in food-handling or storage areas.

Removal frequently, with a minimum daily removal.

Label materials, or printed packaging designated as waste shall be disfigured or

destroyed to ensure that trademarks cannot be reused.

Removal and destruction shall be carried out by approved disposal contractors.

The organization shall retain records of destruction
1.3. WASTE DISPOSAL
1.4. DRAINS AND DRAINAGE
Drains shall be designed, constructed and located so that the risk of contamination of
materials or products is avoided.

Drains shall have capacity sufficient to remove expected flow loads.

Drains shall not pass over processing lines.

Drainage direction shall not flow from a contaminated area to a clean area.
1.4. DRAINS AND
DRAINAGE
1.5. EQUIPMENT SUITABILITY, CLEANING
AND MAINTENANCE
Food contact equipment / surface

 shall be designed and constructed to facilitate cleaning, disinfection and

maintenance.

 shall not affect, or be affected by, the intended product or cleaning system.

 shall be constructed of durable materials able to resist repeated cleaning

1.5 EQUIPMENT SUITABILITY, CLEANING
AND MAINTENANCE
Food contact equipment / surface ….

 smooth, accessible, cleanable surfaces, self draining in wet process areas;

 shall be designed to minimize contact between the operator’s hands and

the products.
 shall be constructed from materials designed for food use: impermeable
and rust or corrosion free.
 Piping and ductwork shall be cleanable, drainable, and with no dead ends
1.5 EQUIPMENT SUITABILITY, CLEANING AND
MAINTENANCE
 1.6 PREVENTIVE AND CORRECTIVE
MAINTENANCE
A preventive maintenance Programmer shall
 be in place.
 include all devices used to monitor and/or control food safety hazards: screens
and filters (including air filters), magnets, metal detectors and X-ray detectors.

 Maintenance requests which impact product safety shall be given priority.

 Temporary fixes shall not put product safety at risk. Permanent repair shall
be done.
 1.6 PREVENTIVE AND CORRECTIVE
MAINTENANCE
Lubricants and heat transfer fluids shall be food grade where there is a risk of
direct or indirect contact with the product.

The procedure for releasing maintained equipment back to production shall

include
 clean up,

 sanitizing, where specified in process sanitation procedures, and

 pre-use inspection.

Maintenance personnel shall be trained in the product hazards associated with

their activities.
1.7 MANAGEMENT OF PURCHASED
MATERIALS 1.7.1 GENERAL
REQUIREMENTS
Purchasing of materials which impact food safety shall be controlled to
ensure that the suppliers used have the capability to meet the
specified requirements.

The conformance of incoming materials to specified purchase

requirements shall be verified.
Materials shall be inspected, tested or covered by Certificate of
analysis (CoA) to verify conformity with specified requirements prior to
acceptance or use. The method of verification shall be documented.
1.7.2 SELECTION AND MANAGEMENT
OF SUPPLIERS

There shall be a defined process for the selection, approval and

monitoring of suppliers.
Examples of a description of how suppliers are assessed include:
1) audit of the supplying site prior to accepting materials for production;
2) appropriate third party certification.

Delivery vehicles shall be checked

1.7.3. INCOMING MATERIAL
REQUIREMENTS (RAW/
INGREDIENTS/PACKAGING)
Materials which do not conform to relevant specifications shall be handled under a
documented procedure which ensures they are prevented from unintended use.
Access points to bulk material receiving lines shall be identified, capped and locked.
1.8 MEASURES FOR PREVENTION OF
CROSS-CONTAMINATION

1.8.1 General requirements

Programmes shall be in place to prevent, control and detect contamination.
Measures to prevent physical, allergen and microbiological
contamination shall be included.
1.8.2 MICROBIOLOGICAL
CROSS-CONTAMINATION
Areas where potential for microbiological cross-contamination exists shall be
identified and a segregation (zoning) plan implemented
Control measures suitable for these areas as follows:
A) Separation of raw from finished products;
b) Structural segregation —physical barriers, walls or separate
buildings;
c) Access controls with requirements to change into required work
wear;
d) Traffic patterns or equipment segregation —people, materials,
equipment and tools (including use of dedicated tools)
1.8.2 MICROBIOLOGICAL CROSS-
CONTAMINATION
 1.8.3 ALLERGEN
MANAGEMENT
Allergens present in the product, either by design or by potential
manufacturing cross-contact, shall be declared: on the label for
consumer products, and on the label or the accompanying
documentation for products intended for further processing.

Products shall be protected from unintended allergen cross-

contact by cleaning and line change-over practices and/or
product sequencing.

Employees handling food should receive specific training in

allergen awareness and associated manufacturing practices
1.8.3 ALLERGEN
MANAGEMENT
1.8.4. PHYSICAL
CONTAMINATION
Where brittle materials are used, periodic inspection
requirements and defined procedures in case of breakage shall be
put in place.

Brittle materials, such as glass and hard plastic components in

equipment, should be avoided where possible
1.8.4. PHYSICAL
CONTAMINATION
Examples of such measures include:
a) adequate covers over equipment or containers for exposed materials or
products;
b) use of screens, magnets, sieves or filters;
c) use of detection or rejection devices such as metal detectors or X-ray.
Sources of potential contamination include wooden pallets and tools,
rubber seals, and personal protective clothing and equipment
1.9. CLEANING AND
SANITIZING
1.9.1 GENERAL
REQUIREMENTS
Facilities and equipment shall be maintained in a condition which
facilitates wet or dry cleaning and/or sanitation.

Cleaning and sanitizing agents and chemicals shall be clearly

identified, food grade, stored separately and used only in accordance
with the manufacturer’s instructions.

Tools and equipment shall be of hygienic design and maintained in a

condition which does not present a potential source of extraneous matter.
1.9.1 GENERAL REQUIREMENTS
1.9.2 CLEANING AND SANITIZING
PROGRAMMES
Cleaning and sanitizing programmes shall be established and
validated by the organization
Cleaning and/or sanitizing programmes shall specify at a
minimum:
a) Areas, items of equipment and utensils to be cleaned and/or sanitized;
b) Responsibility for the tasks specified;
c) Cleaning/sanitizing method and frequency;
d) Monitoring and verification arrangements;
e) post-clean inspections;
f) pre start-up inspections.
1.9.3. CLEANING IN PLACE (CIP)
SYSTEMS

CIP systems shall be separated from active product lines.

Parameters for CIP systems shall be defined and monitored (including

type, concentration, contact time and temperature of any chemicals used).
1.10 PEST CONTROL
1.10.1 PEST CONTROL
PROGRAMMES
A nominated person to manage pest control activities and/or deal with appointed
expert contractors.
Pest management programmes shall be documented and shall identify target pests,
and address plans, methods, schedules, control procedures and, where necessary,
training requirements.
Programmes shall include a list of chemicals which are approved for use in specified
areas of the establishment
1.10.2 PREVENTING
ACCESS
Buildings shall be maintained in good repair. Holes, drains and other
potential pest access points shall be sealed.

External doors, windows or ventilation openings shall be designed to

minimize the potential for entry of pests
 1.10.3. HARBORAGE AND
INFESTATIONS
Storage practices shall be designed to minimize the availability of food and
water to pests.
Potential pest harborage (e.g. burrows, undergrowth, stored items) shall be
removed.
Where outside space is used for storage, stored items shall be protected
from weather or pest damage (e.g. bird
1.10.3. HARBORAGE AND
INFESTATIONS
 1.10.4 MONITORING AND
DETECTION
Pest-monitoring programmes shall include the placing of detectors and traps in key
locations to identify pest activity.
A map of detectors and traps shall be maintained. Detectors and traps shall be designed
and located so as to prevent potential contamination of materials, products or facilities.
The detectors and traps shall be inspected at a frequency intended to identify new pest
activity.
The results of inspections shall be analyzed to identify trends.
 1.10.5 ERADICATION
Eradication measures shall be put in place immediately after evidence of infestation is
reported.
Pesticide use and application shall be restricted to trained operatives and shall be
controlled to avoid product safety hazards.
Records of pesticide use shall be maintained to show the type, quantity and
concentrations used; where, when and how applied, and the target pest.
 1.11 PERSONNEL HYGIENE
1.11.1. PERSONAL HYGIENE
AND EMPLOYEE FACILITIES
Personnel hygiene facilities shall be available to ensure that the degree of personal
hygiene required by the organization can be maintained.
The facilities shall be located close to the points where hygiene requirements apply and
shall be clearly designated.
Establishments shall:
a) provide adequate numbers, locations and means of hygienically washing, drying
and, where required, sanitizing hands (including wash-basins, supply of hot and cold or
temperature controlled water, and soap and/or sanitizer);
1.11.1 PERSONNEL HYGIENE FACILITIES
AND TOILETS
b) have sinks designated for hand washing, whose taps should not be hand operated,
separate from sinks for food use and equipment-cleaning stations;
c) provide an adequate number of toilets of appropriate hygienic design, each with
hand-washing, drying and, where required, sanitizing facilities;

d) have employee hygiene facilities that do not open directly on to production, packing
or storage areas;
e) have adequate changing facilities for personnel;
f) have changing facilities sited to enable personnel handling food to move to the
production area in such a way that risk to the cleanliness of their work wear is minimized.
1.11.2. STAFF CANTEENS AND DESIGNATED
EATING AREAS

Staff canteens and designated areas for food storage and consumption shall be
situated so that the potential for cross-contamination of production areas is minimized.

Staff canteens shall be managed to ensure hygienic storage of ingredients and

preparation, storage and serving of prepared foods.

Storage conditions and storage, cooking and holding temperatures, and time
limitations, shall be specified.

Employees’ own food shall be stored and consumed in designated areas only
 2. VALIDATION
Validation: Establishing documented evidence with high degree of assurance that a
specific process will consistently produce a product meeting its pre-determined
specifications and quality attributes.

Validation allows to demonstrate that equipment has been correctly installed,

functionalities are working properly, and that the equipment produce the expected and
reproducible results

It’s a GMP requirement to prove control of the critical aspects of certain operations.

New facilities and equipment, as well as significant changes to existing systems, require
validation.
2.1
3 steps VALIDATION STEPS
Installation Qualification (IQ): testing to verify that the equipment is
installed correctly

Operational Qualification (OQ): testing to verify that the equipment

operates correctly

Performance Qualification (PQ): testing to verify that product can be

consistently be produced to specification .
 2.2. CHANGE CONTROL
A change control system should be in place to document all changes to
facilities, equipment, or processes that may have an impact on product
quality.

Impact of the change should be evaluated and the extent of re-validation

should be defined.
2.2. CHANGE CONTROL
Examples of types of changes
Addition of new process equipment
Replacement of process equipment or parts
Modifications or minor additions to process equipment
Modifications or minor additions to infrastructure / non-process equipment
Changes in critical process parameter operating limits
Revisions to standard operating procedures
Changes in site-level organizational structure/ key personnel
Changes in raw material/component specifications or sourcing
 3. DOCUMENTATION
Documentation is any communicable material that is used to describe,
explain or instruct regarding some attributes of an object, system or
procedure, such as its parts, assembly, installation, maintenance and use.
Manuals
Standard operating procedures (SOP): give direction for performing certain tasks
and provide higher-level instruction than operating instructions
Work instructions: detail material and equipment requirements and describe the steps to
complete a task

Records: provide a history of each batch and provide a mechanism to check that you
are following operating procedures and instructions.
 3. DOCUMENTATION
SOP’s ALLOW YOU TO:
SAY what you do
DO what you say
PROVE it

Record: real time evidence that a mandatory activity has been completed
Ensure Traceability: efficient and accurate withdrawals and recalls of
unsafe foods from the market can be made in the event of any food safety
problems.
 4. TRACEABILITY
The traceability system shall be able to uniquely identify in coming
material from the supplier sand first stage of the distribution route of the
end product
The following shall be considered as a minimum:
Relation of lots of received materials, ingredients and intermediate products to the
end products
Reworking of materials/products
Distribution of the end product
Statutory, regulatory and customer requirements are identified
Documented information as evidence of traceability shall be retained for a defined
period as a min. the shelf life of the product
The organization shall verify and test the effectiveness of the system
4. TRACEABILITY
 5. PERSONNEL/
COMPETENCY
Determine necessary competencies of persons
Ensure that all persons and those responsible for the operation of the hazard
control plan are competent

Ensure that the responsible for the operation –have sufficient knowledge
and experience –organisations products, processes, equipment and basic
GMP

Competency matrix

Documented information as evidence of competence

5. PERSONNEL/
COMPETENCY
Regular training which covers e.g. operations and GMP with
periodic assessment of training

Training records maintained. Training should be periodically

assessed
IDENTIFY WHO DOES WHAT

All employees should clearly understand what they have to do each day.
It avoids misunderstandings and minimizes the risk to product quality.
Create a job description for each role to define: job title, job objective,
duties and responsibilities, skill requirements.
There should be no gaps or overlaps in responsibilities

Create an organizational chart and display it on the intranet or a local

notice board.
ORGANIZATIONAL CHART
6. PERFORM REGULAR
AUDITS
Audits must be conducted to assess the GMP rules are implemented and are effective.

Internal Audit-Trained employees

Check list

External bodies such as EFDA, ECAE, third Party certification bodies

Corrective Action Preventative Action (CAPA) system to manage and fix anything
found during an audit.
Thank
you