The document provides an overview of Good Manufacturing Practices (GMP). It discusses that GMPs are procedures and universal steps that provide basic environmental conditions and management systems necessary for safe food production. It outlines 10 key areas of GMP including facilities, equipment, water supply, waste disposal, cleaning, and personnel practices. The document emphasizes that GMPs focus on preventative measures and each facility must implement supervision and monitoring systems to ensure food safety.
2. GOOD MANUFACTURING PRACTICES
(GMP)
The Good Manufacturing Practices (GMP) are
the procedures or universal steps which provide
the basic environmental conditions and a
management system structure necessary for the
production of safe and wholesome foods.
Food Quality Systems -HACCP, GMP, ISO &
Codex .
4. GMPs ARE:
Preventative measures to ensure food safety.
Based on practical experience over a long period of
time.
The foundation on which to build a HACCP (Hazard
analysis and critical control points) program.
5. Each firm must develop procedures to ensure that an
effective food safety program has been implemented, and
that adequate supervision and monitoring systems are in
place to ensure that problems are identified and promptly
corrected.
A team consisting of plant workers, managers, supervisors
and quality control staff is likely to be involved in the routine
activities and tasks in the facility, ensuring that each firm
meets the requirements and conditions outlined in the GMP
regulation.
6. PREREQUISITE PROGRAMS
Applicable to the overall manufacturing
environment.
Includes Good Manufacturing Practices
Foundation for an effective HACCP program
7. EXAMPLES OF COMMON
PREREQUISITE PROGRAMS
Facilities
Production equipment
Standard operating procedures
Supplier controls
Production specification
Personnel policies
Traceability and recalls
8. GMP-10 KEY AREAS
Layout and Building Design
1. Processing Equipment
2. Services
• Water
• Electrical connections
• Waste water
3. Maintenance
4. Incoming Materials
• All ingredients that go into the product
• Primary, Secondary and Tertiary packaging
9. GMP-10 Key Areas
6. Processing
• Defined operations to stabilize a product
7. Cleaning and Sanitizing
• Removal of contaminates from the process system and food
residue
8. Storage, Transport, and Distribution
9. Personnel
• Training is critical
10. Pest Prevention
10. BUILDINGS AND FACILITIES
Plant and grounds.
(A) GROUNDS. The grounds about a food plant
shall be kept in a condition that will protect
against the contamination of food. The methods
for adequate maintenance of grounds include,
Properly storing equipment, removing litter and
waste, and cutting weeds or grass.
11. Maintaining roads, yards, and parking lots so that
they do not constitute a source of contamination in
areas where food is exposed.
Operating systems for waste treatment and
disposal in an adequate manner.
12. (B) PLANT CONSTRUCTION AND DESIGN.
Plant buildings and
structures shall be suitable in size, construction, and
design to facilitate maintenance and sanitary
operations.
Provide adequate lighting in hand-washing areas,
dressing and locker rooms, and toilet rooms and in all
areas where food is examined, processed, or stored
and
13. Provide adequate ventilation or control equipment
to minimize odors and vapors (including steam and
noxious fumes) in areas where they may
contaminate
Food.
14. SANITARY FACILITIES AND
CONTROLS.
Each plant shall be equipped with adequate
sanitary
facilities and accommodations including,
(A) WATER SUPPLY. The water supply shall be
sufficient
for the operations intended and shall be derived
from
an adequate source.
(B) PLUMBING. Plumbing shall be of adequate size
15. (C) SEWAGE DISPOSAL. Sewage disposal shall be made into an
adequate sewerage system.
(D) TOILET FACILITIES. Each plant shall provide its
employees with adequate, readily accessible toilet
facilities.
(E) HAND-WASHING FACILITIES. Hand-washing facilities
shall be adequate and convenient and be furnished with running
water at a suitable temperature.
16. SANITATION STANDARD
OPERATING
PROCEDURES(SSOP)
Sanitation standard operating procedures should
include:
General maintenance
Substances used in cleaning and sanitizing
Storage of toxic materials
Pest control
Storage and handling of clean portable
equipments and utensils.
Rubbish disposal.
17.
18.
19. WHAT ARE CCPs
(Critical Control Points)?
A CCP is a key step where hazards can be
prevented, eliminated or reduced to an
acceptable level.
PURPOSE OF MONITORING:
To identify when there is loss of control (a
deviation occurs at a CCP), and
To provide written documentation of the process
control system.
20. WHAT WILL BE MONITORED?
Cold storage temperature
pH of an acidifying ingredient
Line speed
21. VERIFICATION OF CCPS
Calibration
Calibration record review
Targeted sampling and testing
CCP record review
32. CLEANING OF PREMISES
Areas to be cleaned.
Methods of cleaning.
Person responsible, and
Frequency of the activity.
33. PEST CONTROL
(किट - नियत्रण)
The presence of pests in food
production and preparation
areas has always been
unacceptable.
The spread of disease –
Pathogens are transferred .
Damage to property .
Contamination of work
surfaces and foodstuffs.
Adverse public opinion and
loss of reputation.
34. REPORTING AND RECORD
KEEPING
The organization of a reporting system and maintenance of
records is essential if Good Manufacturing Practice (GMP)
status is to be achieved.
Pest sightings log:
This can be in the form of a book or a folder where the
following information can be logged:
• Name of person making report
• Date and time
• Location
• Pest seen
• Any other relevant information
35. TYPES OF PESTS AND THEIR
CONTROL
RATS
SQUIRRELS
MICE
COCKROACHES
FLIES
ANTS
STORED PRODUCT INSECTS
BIRDS AND OTHER VERTEBRATES
36. PREVENTING ACCESS:
Entrance sites
External and internal inspection
THOROUGH INSPECTION OF FOOD PREMISES:
Each site should be divided into high intermediate-low risk areas. High risk
areas: Areas where there is a greater risk of compromising food safety from
pest activity.
HIGH RISKS AREAS:
Typical high risk areas and potential pests would be:
• Incoming raw and packaged food and stored product pests
• Finished goods warehouses and mice
• Food preparation areas and flying insects
37. Intermediate risk Areas:
Where there is a risk of compromising food safety
from pest activity but where the product is not
particularly high risk.
Low risk areas:
Areas where there is minimal risk of compromising
food safety from pest activity or where the product is
low risk.
39. QUALITY ASSURANCE
The quality check should ensure that:
Work on site is carried out in a safe
manner
Pests are identified, reported and
eliminated within the required
timescales
Inspections and follow up visits
meet the terms of the specification
Pesticides are applied safely
Rodent and insect monitoring
stations are clean, adequately
serviced and correctly sited
Rodent monitoring stations are
securely fixed and locked where
necessary
The report folder is well organized
and up-to-date.
40. PERSONAL HYGIENE
OBJECTIVE:
To ensure that those who come directly or indirectly into
contact with food are not likely to contaminate it.
HEALTH STATUS:
Illness
Injuries
Individual health cards
41.
42. PERSONAL CLEANLINESS:
Hand washing
Use of antiseptic on hands
Wear clean cloths
Wear protective apparel to prevent
contamination
• Practice good sanitation.
• If you are sick or have open lesions that would
impact the drug, then you will be excluded from
direct contact with the product.
43. UNIFORM:
Should be kept clean and in good condition
MASKS AND GLOVES:
Should be used at the time of production and
analysis.
44. PERSONAL BEHAVIOR
People engaged in food-handling activities should refrain
from behavior that could result in contamination of food, for
example:
• smoking
• spitting
• sneezing or coughing over unprotected
food
45. OTHER POINTS IN GMP
Lot identification
Production information
Labeling
Cross contamination: Measures that can be taken to
prevent cross-contamination also include:
Segregated areas
Ventilation systems
Airlocks
Clothing
Closed processing systems
Cleaning and decontamination
46. SAMPLING
Shall be representative
maintain cleanliness
in approved area
prevent cross contamination
containers marked showing samples taken
47. PRODUCTION AND PROCESS
CONTROL
Written procedures
Document activities(batch record, log books)
Control contamination
Cleanliness(tanks ,paddles ,piping , probes etc)
keep organized.
48. WAREHOUSE
It shall be clean.
Sections clearly identified(quarantine, released
or rejected).
Track inventories and sold outs.
49. LABORATORIES
Will have specifications ,standards , sampling
plans , test procedures.
Shall have a calibration and maintenance
program(written with a time period of
performance).
Use logbooks for documentation of all testings.
Stability testing should be done.
51. GMP INCLUDES:
Water
Facilities for personal hygiene
Air quality and ventilation
Lighting
Storage
Operation controls
Time and temperature control
Cross contamination
Raw materials
Packaging
53. 10 BASIC PRINCIPLES OF
GMP:
Writing procedures
Following written procedures
Documenting for traceability
Designing facilities and equipment
Maintaining facilities and equipment
Validating work
Job competence
Cleanliness
Component control
Auditing for compliance
54. FOCUS IS ON HAZARD
PREVENTION, RATHER
THAN HAZARD DETECTION