Transcript Good Manufacturing Practices

Hafsa Ashraf 02
Razia Jahangir 03
B.Sc. (Hons). Food Science and
Technology
8th semester (Regular)
world food prgorammes
Prerequisites for food safety
GMP
Good Manufacturing Practices Worldwide Enforcement
Why GMP?
Good manufacturing practices
Basic requirements for GMP
Good personal hygiene
Food handling practices
GMP programmes
Summary GMP
GMP regulations
Neccesity of GMP
Implementation of GMP
Ten GMP Principles
Codex general principles
Effective use of GMP
GMP and Management
WHO – GMP certificate
Conclusions
 Food
quality control is necessary to ensure that
food aid supplies are safe, of good quality and
available in adequate amounts, in time, at
affordable prices to ensure an acceptable
nutritional and health status for all population
groups
 Food
quality systems – HACCP, GMP, ISO &
Codex Alimentarius
 Good Agricultural
Practices (GAPs)
 Good
Manufacturing Practices (GMPs) or
 Good
Hygiene Practices (GHPs)
 Other
GPs (GTP, GDP, GRP, etc)
A
set of regulations, codes, and
guidelines

For
the
manufacture
of
drug
substances and drug products, medical
devices, in vivo and in vitro diagnostic
products, and foods.

Good Manufacturing Practices are enforced in the United
States by the FDA

In the United Kingdom by the Medicines and Healthcare
Products Regulatory Agency

GMPs are enforced in Australia by the Therapeutically Goods
Administration


In India by the Ministry of Health, multinational and/or foreign
enterprises

Many underdeveloped countries lack GMPs
Provides a high level assurance that FOODS are
manufactured in a way that ensures their safety,
efficacy and quality
Quality is built in
 Testing
is part of GMP, but alone does
not provide a good level of quality
assurance
A standard which covers the manufacturing of
packaging made of coruugated and solid board in
order to fulfill legal requirements
GMP means having a total control system in place
in each manufacturing plant.
Purpose is to ensure that from the purchase of raw
material to the dielevry of the finished product to
the customers
Quality Management
Quality Assurance
GMP
Production and Quality Control
 That
part of QA that ensures that products are
consistently produced and controlled
 Quality
standards
 Marketing authorization
 Aim:
Diminishing risks that cannot be controlled by
testing of product
 Contamination and
cross-contamination
 Mix-ups (confusion)
 Clearly
defined and systematically reviewed processes
 Qualification and validation is performed
 Appropriate resources are provided:
Qualified and trained personnel
Premises, space, equipment and services
Materials, containers, labels
Procedures, storage, transport
Laboratories and in-process control
 Clear,
written instructions and procedures
 Trained
operators
 Records
of actions, deviations and investigations
 Records
for manufacture and distribution
 Proper
storage and distribution
 Systems
for complaints and recalls
Deal with contamination
by people
by food materials
by packaging materials
by hazardous materials
by miscellaneous materials
All employees working in direct contact with food,
food contact surfaces and food packaging must
conform to hygienic practices. This protects
against food contamination by microorganisms or
unwanted material.
Careless employee practices can cause
product contamination.
The best way to avoid contamination is to
prevent it.
 hair
 personal habits
 hand washing
 illness and disease
 injuries
 visitors
 training
Clothing
Bathe daily
No perfume, aftershave, fragrant creams
No jewellery
No false nails or nail polish
Fingernails should be trimmed short
Use metal detectable bandages covered with
gloves
No eating, drinking or chewing gum

Everyone must wear pants and covered sleeves.

Separate shoes (no open toes or high heels) are to
be worn in the factory.

Personal belongings and street clothing must be
stored in locker rooms.
Doctor’s certificate on hiring
Inform your supervisor or HR if you are ill with
symptoms that could contaminate ingredients or
products
No medication allowed in factory
Ensure that a clean bandage covers any open
wounds
All employees must wash their hands thoroughly:
when they enter food handling areas
before starting work
after handling contaminated materials
after breaks
after using toilet facilities
Do not leave gloves, masks, etc. lying
around while on break or at shift end.
Crates, boxes, containers or buckets must not be
placed directly on the floor.
Store brooms and dust pans at stations provided.
Keep hand contact with ingredients to a minimum.
Check ingredients for expiration dates to ensure
that fresh ingredients are used.
Cooling product should always be kept covered.
o
Ensure that all containers, including those holding
rework, are properly labelled and are kept
covered.
o Use white or brown containers to store ingredients
and rework.
o Use gray containers for garbage. Garbage
containers must be kept covered.

Use white cloths to wipe hands regularly and dispose of
soiled cloths immediately. No moist cloths are to be left in
the production area.

Use yellow cloths to clean the floor and objects (e.g. step
stools) that come into contact with the floor.
Scrapers for moulds and tabletops are not to be
used on the floor.
Production equipment/utensils must be
thoroughly cleaned and sanitized with alcohol
after use.
Keep unscreened doors and windows closed.
Report any pests or evidence of pests such as flies,
insects, mice droppings.
Return tools and attachments to their proper place
after use.
Check product surfaces before starting equipment.
Remove any foreign objects or dirt.
Replace brushes that lose bristles.
Do not lean, sit or step on product surfaces.
Do not handle ingredients or products with either cut
or infected hands.
Do not engage in horseplay.
Keep hand contact with ingredients and product to a
minimum.

Ensure that all pallets and materials are kept at least 18”
away from the walls.

Inspect torn bags and boxes and then repair if appropriate.

Brush off bags and boxes before opening them.

Store ingredients and products at the appropriate
temperature.

Use ingredients in the proper rotation (oldest stock
first)

Handle ingredients or products carefully to avoid
spilling

Do not return products or ingredients to the
production line after they have touched the floor or
any other surface that is not clean.
Ensure area is segregated from production by use of
tarps.
Do not leave maintenance supplies in the product zone.
Return all tools and attachments to their proper place
after use.
Ensure the production area is clear of all tools and
hazards before production starts
Monitor and maintain proper temperatures
Rotate ingredients and check for expired items.
Check best before dates and the quality of the food before
using.
Refrigerate cold foods immediately upon receipt.
Sanitize
equipment, cutting boards, work surfaces and
utensils.
Always wash hands after handling money.
 Should always be accompanied.
 Must be appropriately dressed - hair
coverings, booties over street shoes, gloves,
sleeve covers, etc.
A GMP programme provides a framework to manage food
safety and for each covered production site or product
should describe
organizational structures and responsibilities,
 procedures and processes, and
 available resources.

Create a valuable internal source of know-how
 Establishes
minimum GMP for methods to be used, and the
facilities or controls to be used for, the manufacture,
processing, packing or holding of a drug to assure that the
drug is:
 Safe
 Has
the appropriate identity and strength
 Meets quality and purity characteristics
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Yes. Good quality must be built in during the
manufacturing process
It cannot be tested into the product afterwards.
GMP prevents errors that cannot be eliminated
through quality control of the finished product.
Without GMP it is impossible to be sure that every
food item is of the same.
 GMP
is designed to ensure that mistakes do not occur.
 Making
 They
poor products does not save money
are more expensive finding mistakes they have
been made than preventing them in first place
 GMP
contains ten principles that introduces
employees to critical behaviours established
established by FDA and industry leaders to
maintain good manufacturing practices in
plants

Writing procedures

Following written procedures

Documenting for traceability

Designing facilities and equipments

Mainatining facilities and equipments

Validating work

Job Competence

Cleaniliness

Competent control

Auditing for compliance
Following good practices will contribute to the
economic viability of a food business by
raising customer confidence,
 minimising risk of costly food recalls,
 creating a workforce that understands the
concept of safe food production, and
 reducing waste during the whole production
process

Management has different possibilities of assessing
food safety concerns:
 Customer
complaints
 Discussion
 Audit
with staff involved in food safety
feed-back
 Evaluating number
of food safety mistakes
made in each department
 Foodborne
diseases and threats to food safety are a growing
public health problem.
 Codes
of good practice cover the fundamental principles,
procedures and means needed for producing safe food.
 The
management of food safety and quality is demonstrated
by establishing documented GMP programmes.
 Governments
can consider using the Codex General
Principles of Food Hygiene as a basis for their food
safety policies.
 A business’ commitment
management level.
to food safety starts at

GMP compliance is not an option

Quality should be built into the product

GMP's are very similar and are really Good Common Sense

Good Practices cover all aspects of manufacturing activities
prior to supply

The role and involvement of senior management is crucial