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TRAINING
ON
GOOD
MANUFACTURING
PRACTICES
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 .
FOOD QUALITY SYSTEMS
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.
 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.
PREREQUISITE PROGRAMS
 Applicable to the overall manufacturing
environment.
 Includes Good Manufacturing Practices
 Foundation for an effective HACCP program
EXAMPLES OF COMMON
PREREQUISITE PROGRAMS
 Facilities
 Production equipment
 Standard operating procedures
 Supplier controls
 Production specification
 Personnel policies
 Traceability and recalls
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
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
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.
 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.
 (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
 Provide adequate ventilation or control equipment
to minimize odors and vapors (including steam and
noxious fumes) in areas where they may
contaminate
Food.
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
(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.
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.
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.
WHAT WILL BE MONITORED?
 Cold storage temperature
 pH of an acidifying ingredient
 Line speed
VERIFICATION OF CCPS
 Calibration
 Calibration record review
 Targeted sampling and testing
 CCP record review
IMPORTANT ASPECTS OF
GMP
CONTROL OF FOOD
HAZARDS
SPECIFIC PROCESS STEPS
WATER
 WATER QUALITY
 CHLORINE
 ANALYSIS
 CLEANING OF RESERVOIRS
 ICE-MAKING
 STEAM PRODUCTION
 DRAINAGE
 PLUMBING
ASPECTS TO BE
CONSIDERED
CLEANING OF EQUIPMENT
 CIP
 MANUAL
 AUTOMATIC
 IMMERSION
 DRYING
CLEANING OF PREMISES
 Areas to be cleaned.
 Methods of cleaning.
 Person responsible, and
 Frequency of the activity.
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.
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
TYPES OF PESTS AND THEIR
CONTROL
 RATS
 SQUIRRELS
 MICE
 COCKROACHES
 FLIES
 ANTS
 STORED PRODUCT INSECTS
 BIRDS AND OTHER VERTEBRATES
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
 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.
WASTE MANAGEMENT
(िचरा प्रबंधि)
WASTE MANAGEMENT:
 Storage areas
 Waste bins
 Proper cleaning and
sanitizing
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.
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
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.
UNIFORM:
 Should be kept clean and in good condition
MASKS AND GLOVES:
 Should be used at the time of production and
analysis.
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
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
SAMPLING
 Shall be representative
 maintain cleanliness
 in approved area
 prevent cross contamination
 containers marked showing samples taken
PRODUCTION AND PROCESS
CONTROL
 Written procedures
 Document activities(batch record, log books)
 Control contamination
 Cleanliness(tanks ,paddles ,piping , probes etc)
 keep organized.
WAREHOUSE
 It shall be clean.
 Sections clearly identified(quarantine, released
or rejected).
 Track inventories and sold outs.
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.
POINTS TO
REMEMBER
GMP INCLUDES:
 Water
 Facilities for personal hygiene
 Air quality and ventilation
 Lighting
 Storage
 Operation controls
 Time and temperature control
 Cross contamination
 Raw materials
 Packaging
 Product information
 Traceability
 Pest control
 Personal hygiene
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
FOCUS IS ON HAZARD
PREVENTION, RATHER
THAN HAZARD DETECTION
THANK YOU

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Learn GMP fundamentals in under 2 minutes

  • 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.
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  • 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
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  • 29. WATER  WATER QUALITY  CHLORINE  ANALYSIS  CLEANING OF RESERVOIRS  ICE-MAKING  STEAM PRODUCTION  DRAINAGE  PLUMBING
  • 31. CLEANING OF EQUIPMENT  CIP  MANUAL  AUTOMATIC  IMMERSION  DRYING
  • 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.
  • 38. WASTE MANAGEMENT (िचरा प्रबंधि) WASTE MANAGEMENT:  Storage areas  Waste bins  Proper cleaning and sanitizing
  • 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
  • 52.  Product information  Traceability  Pest control  Personal hygiene
  • 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