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Dau Shri Vasudev Chandrakar Chhattisgarh Kamdhenu
Vishwavidyalaya, Anjora, Durg, Chhattisgarh
L.S.P.N. College of fisheries, Kawardha
TOPIC
GMP , GLP ,GHP
Submitted To
Ms. VARSHA LIKHAR
Submitted By
DEVENDRA KUMAR
CHAND
INTRODUCTION
• GMP, GLP, and GHP are quality control standards used in various
industries to ensure that products are manufactured and handled in a
safe and consistent manner.
Good Manufacturing Practice
(GMP)/Good Hygienic Practices (GHP)
• GMP/GHP is defined as all practices regarding conditions and
measures necessary to ensure safety and suitability (quality) of food at
all stages of the food chain. This is largely the procedure laid down for
achieving safety from plant, machinery and other infrastructure used in
the production.
The important elements of Good
Manufacturing Practice are listed below:
• 1) Plant design, construction and layout:
• In any production plant, there will be raw materials and finished products as
well as one or many intermediate products.
• The plant design shall be such that the movement of edible materials from
raw materials stage to the finished products stage is unidirectional and
opposite to the movement of waste materials like solid wastes and liquid
effluents.
• Another aspect of the plant design and construction is the nature of the
materials used for the construction and the type of construction.
• The plant will also need several electrical and mechanical fittings.
• All such items shall be washable and laid out in such a way that there is no
scope for pest/microbial harbourage.
2) Machinery design, construction and
layout
• Like plant, machinery too shall be designed, constructed and installed
to facilitate unidirectional movement of food materials and that the
machinery is water resistant, washable and subitizable.
• All the machinery shall also be in a position to achieve criteria for
good manufacturing practice.
• Selection and installation of processing machinery in this way will
exclude all possible health risks from machinery.
3) Provision for pest control
• The provision for pest control is often a neglected item. Pest can be the
cause for both dirt and contamination with microbes of public health
significance.
• Effective operation of these facilities will make food-handling areas
free from pests.
• However, there shall not be a regular schedule for fumigation as it may
introduce unwanted chemical residues into the food material handled
in the plant.
4) Personnel Involved in Production
• Workers or plant personnel are the most dynamic source of various
type of microbial contamination in any food-processing establishment.
In case of food materials from land and inland water bodies, there is
every chance of occurrence of organisms of public health significance.
• in case of seafood, the occurrence of Public Health Indicator
organisms is a sure indic
• To exclude such contamination from workers, all personnel in the
production unit shall follow good hygiene practice.
• A) Medical Fitness of workers
• b) Use of clean uniform including gum boots, head cover, face mask
and gloves
• c) Removal of ornaments and other beauty aids
• d) Scrubbing of hands with soap and clean water
• e) Sanitized footwear using a foot dip containing 100 ppm
• f) Hand sanitizing by dipping the full palm of both hands in 20 ppm
of chlorine water
5) Cleanliness of Direct/Indirect Food
Contact Surfaces
• The cleanliness of direct and indirect food contact surfaces is
responsible for contamination of food.
• There shall be identification and listing of all food contact and non-
contact surfaces followed by a cleaning procedure and cleaning
schedule.
• All these operations are popularly known as ―Standard Sanitation
Operation Procedure‖ (SSOP).
• 6) Risk/Hazard Monitoring Facilities
• The success of all the above processes and procedures in a food plant
will depend on the facilities of the laboratory.
• In fact, the laboratory shall have all test methods and testing
equipment in par with the national and international requirements.
• 7) Traceability and recall procedures
• A system for tracing all raw materials and finished products is a
necessary component in a prerequisite programme.
• No process is fail-safe and traceability that includes lot identification
is essential to an effective recall procedure. A crisis response plan
should be in place to handle any incidents.
• 8) Training
• All employees should receive documented training on personal
hygiene, GHP, cleaning and disinfection procedures, product handling
and protection, the HACCP-system and process control.
• Periodic refresher training should be part of the overall training
programme.
• Training in basic food hygiene is fundamentally important. All
personnel should be aware of their roles and responsibilities in
protecting fish and the fish products from contamination and
deterioration.
• Good Laboratory Practices (GLPs)
• Good Laboratory Practices (GLPs) define the rules and criteria for a
quality system concerned with the organizational process and the
conditions under which non-clinical health and environmental safety
studies are planned, performed, monitored, recorded and reported.
• General Principles of the good laboratory practices
• a) Management‘s Responsibilities
• Most of the responsibilities of test facility management are of a
general nature, such as the requirements that test facility management
has to ensure the availability of qualified personnel and of appropriate
facilities and equipment for the timely and proper conduct of the study.
• Furthermore, it has to ensure that health and safety precautions are
applied according to national and/or international regulations;
appropriate Standard Operating Procedures are established and
followed, etc
• b) Laboratory Head‘s Responsibilities
• The study director continues to be the single point of study control and
has the responsibility for the overall conduct and reporting of the
study.
• He/she should agree to the study plan and ensure that the procedures
specified in the study plan are followed.
• c) Personnel Responsibilities
• Personnel should exercise safe working practice and health
precautions; the chemicals should be handled with suitable caution
until their hazard(s) has been established.
• Personnel known to have a health or medicinal condition that is likely
to have an adverse effect on the study should be excluded from
operations that may affect the study.
• d) Facilities
• The GLP Principles mandate in general that test facilities should be of
suitable size, construction and location to meet the requirements of the
studies performed therein, and an adequate degree of separation should
be provided between the different activities to ensure the proper
conduct of each study.
• e) Apparatus, material, and reagents
• Apparatus should be suitably located, be of appropriate design and
adequate capacity, and should be periodically inspected, cleaned,
maintained and calibrated according to SOPs.
• Apparatus and materials should not interfere with the test systems, and
reagents should be properly labelled
• f) Test Systems
• All the methods used by the lab shall be approved methods by national
or international agencies, like BIS standards (Bureau of Indian
Standards), EU (European Union) Norms, US FDA (United States
Food and Drug Administration) Guides and Codex.
• Under no circumstances, unapproved procedures shall be used for
monitoring any process/quality parameter.
• Conclusion:
• The increasing demand of consumers for fish and fishery products,
and the internationalization of the food supply generally have created
an increased need for regulatory inspection and control of imported
foods.
• The establishment of GMP in a plant will make organized and
documented system for whole production along with Improvement of
the quality of products.
• The final product will meet consumer requirements and improves the
efficiency. Proper management of waste will protect the environment.
• GLP sets good practice to perform work in compliance with
standardize procedures worldwide.
• GLP sets good practice to perform work in compliance with
standardize procedures worldwide.
Devendra kumar chand.pptx

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Devendra kumar chand.pptx

  • 1. Dau Shri Vasudev Chandrakar Chhattisgarh Kamdhenu Vishwavidyalaya, Anjora, Durg, Chhattisgarh L.S.P.N. College of fisheries, Kawardha TOPIC GMP , GLP ,GHP Submitted To Ms. VARSHA LIKHAR Submitted By DEVENDRA KUMAR CHAND
  • 2. INTRODUCTION • GMP, GLP, and GHP are quality control standards used in various industries to ensure that products are manufactured and handled in a safe and consistent manner.
  • 3. Good Manufacturing Practice (GMP)/Good Hygienic Practices (GHP) • GMP/GHP is defined as all practices regarding conditions and measures necessary to ensure safety and suitability (quality) of food at all stages of the food chain. This is largely the procedure laid down for achieving safety from plant, machinery and other infrastructure used in the production.
  • 4. The important elements of Good Manufacturing Practice are listed below: • 1) Plant design, construction and layout: • In any production plant, there will be raw materials and finished products as well as one or many intermediate products. • The plant design shall be such that the movement of edible materials from raw materials stage to the finished products stage is unidirectional and opposite to the movement of waste materials like solid wastes and liquid effluents. • Another aspect of the plant design and construction is the nature of the materials used for the construction and the type of construction. • The plant will also need several electrical and mechanical fittings. • All such items shall be washable and laid out in such a way that there is no scope for pest/microbial harbourage.
  • 5. 2) Machinery design, construction and layout • Like plant, machinery too shall be designed, constructed and installed to facilitate unidirectional movement of food materials and that the machinery is water resistant, washable and subitizable. • All the machinery shall also be in a position to achieve criteria for good manufacturing practice. • Selection and installation of processing machinery in this way will exclude all possible health risks from machinery.
  • 6. 3) Provision for pest control • The provision for pest control is often a neglected item. Pest can be the cause for both dirt and contamination with microbes of public health significance. • Effective operation of these facilities will make food-handling areas free from pests. • However, there shall not be a regular schedule for fumigation as it may introduce unwanted chemical residues into the food material handled in the plant.
  • 7. 4) Personnel Involved in Production • Workers or plant personnel are the most dynamic source of various type of microbial contamination in any food-processing establishment. In case of food materials from land and inland water bodies, there is every chance of occurrence of organisms of public health significance. • in case of seafood, the occurrence of Public Health Indicator organisms is a sure indic • To exclude such contamination from workers, all personnel in the production unit shall follow good hygiene practice.
  • 8. • A) Medical Fitness of workers • b) Use of clean uniform including gum boots, head cover, face mask and gloves • c) Removal of ornaments and other beauty aids • d) Scrubbing of hands with soap and clean water • e) Sanitized footwear using a foot dip containing 100 ppm • f) Hand sanitizing by dipping the full palm of both hands in 20 ppm of chlorine water
  • 9. 5) Cleanliness of Direct/Indirect Food Contact Surfaces • The cleanliness of direct and indirect food contact surfaces is responsible for contamination of food. • There shall be identification and listing of all food contact and non- contact surfaces followed by a cleaning procedure and cleaning schedule. • All these operations are popularly known as ―Standard Sanitation Operation Procedure‖ (SSOP).
  • 10. • 6) Risk/Hazard Monitoring Facilities • The success of all the above processes and procedures in a food plant will depend on the facilities of the laboratory. • In fact, the laboratory shall have all test methods and testing equipment in par with the national and international requirements.
  • 11. • 7) Traceability and recall procedures • A system for tracing all raw materials and finished products is a necessary component in a prerequisite programme. • No process is fail-safe and traceability that includes lot identification is essential to an effective recall procedure. A crisis response plan should be in place to handle any incidents.
  • 12. • 8) Training • All employees should receive documented training on personal hygiene, GHP, cleaning and disinfection procedures, product handling and protection, the HACCP-system and process control. • Periodic refresher training should be part of the overall training programme. • Training in basic food hygiene is fundamentally important. All personnel should be aware of their roles and responsibilities in protecting fish and the fish products from contamination and deterioration.
  • 13. • Good Laboratory Practices (GLPs) • Good Laboratory Practices (GLPs) define the rules and criteria for a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded and reported.
  • 14. • General Principles of the good laboratory practices • a) Management‘s Responsibilities • Most of the responsibilities of test facility management are of a general nature, such as the requirements that test facility management has to ensure the availability of qualified personnel and of appropriate facilities and equipment for the timely and proper conduct of the study. • Furthermore, it has to ensure that health and safety precautions are applied according to national and/or international regulations; appropriate Standard Operating Procedures are established and followed, etc
  • 15. • b) Laboratory Head‘s Responsibilities • The study director continues to be the single point of study control and has the responsibility for the overall conduct and reporting of the study. • He/she should agree to the study plan and ensure that the procedures specified in the study plan are followed.
  • 16. • c) Personnel Responsibilities • Personnel should exercise safe working practice and health precautions; the chemicals should be handled with suitable caution until their hazard(s) has been established. • Personnel known to have a health or medicinal condition that is likely to have an adverse effect on the study should be excluded from operations that may affect the study.
  • 17. • d) Facilities • The GLP Principles mandate in general that test facilities should be of suitable size, construction and location to meet the requirements of the studies performed therein, and an adequate degree of separation should be provided between the different activities to ensure the proper conduct of each study.
  • 18. • e) Apparatus, material, and reagents • Apparatus should be suitably located, be of appropriate design and adequate capacity, and should be periodically inspected, cleaned, maintained and calibrated according to SOPs. • Apparatus and materials should not interfere with the test systems, and reagents should be properly labelled
  • 19. • f) Test Systems • All the methods used by the lab shall be approved methods by national or international agencies, like BIS standards (Bureau of Indian Standards), EU (European Union) Norms, US FDA (United States Food and Drug Administration) Guides and Codex. • Under no circumstances, unapproved procedures shall be used for monitoring any process/quality parameter.
  • 20. • Conclusion: • The increasing demand of consumers for fish and fishery products, and the internationalization of the food supply generally have created an increased need for regulatory inspection and control of imported foods. • The establishment of GMP in a plant will make organized and documented system for whole production along with Improvement of the quality of products. • The final product will meet consumer requirements and improves the efficiency. Proper management of waste will protect the environment. • GLP sets good practice to perform work in compliance with standardize procedures worldwide.
  • 21. • GLP sets good practice to perform work in compliance with standardize procedures worldwide.