GMP, GLP, and GHP are quality control standards used in various industries to ensure safe and consistent production. GMP focuses on plant design, machinery, pest control, personnel hygiene, cleaning procedures, hazard monitoring, and traceability. Key elements of GLP include management responsibilities, study planning, personnel roles, facilities, equipment, and approved test methods. Together, these standards help ensure products are manufactured and tested according to international guidelines, protecting consumers and the environment.
Unit 2 organization and personnel and permisies himanshuhimanshu kamboj
pharmaceutical quality assurance
b pharma 6th sem
Personnel objectives
Personnel qualifications
Personnel responsibilities
Key personnel
Responsibilities of the head of the production department
Responsibilities of the head of quality control department
Training
Personnel hygiene
Premises
Layout of pharmaceutical industry
Areas of premises
Environmental control in sterile areas
Equipment and raw materials
Stages of equipment
Cleaning and maintenance
Raw materials
Steps involved in purchase procedure
Maintenance of stores
Storage conditions
Unit 2 organization and personnel and permisies himanshuhimanshu kamboj
pharmaceutical quality assurance
b pharma 6th sem
Personnel objectives
Personnel qualifications
Personnel responsibilities
Key personnel
Responsibilities of the head of the production department
Responsibilities of the head of quality control department
Training
Personnel hygiene
Premises
Layout of pharmaceutical industry
Areas of premises
Environmental control in sterile areas
Equipment and raw materials
Stages of equipment
Cleaning and maintenance
Raw materials
Steps involved in purchase procedure
Maintenance of stores
Storage conditions
Quality control during processing and storageJuhiMishra16
describes about microbiological quality criteria and about indicator organisms and their isolation. lays emphasis on GMP and HACCP AND ITS PRINCIPLES. also describes about risk analysis
Quality control measures in pharmaceutical industryChemOnTheGo
QUALITY CONTROL
ROLE OF QUALITY CONTROL IN PHARMACEUTICAL INDUSTRY
OBJECTIVES OF QUALITY CONTROL
STEPS IN QUALITY CONTROL
COST OF QUALITY CONTROL
TOTAL QUALITY MANAGEMENT
QUALITY CIRCLE
Good Manufacturing Practice is a part of quality assurance which ensure that the products are consistently produced and controlled according to quality standards appropriate to their intended use.
Pharmaceutical Microbiology: Current and Future Challenges Tim Sandle, Ph.D.
The changing environment for pharmaceutical microbiology
Limitations of methods
Need for new (rapid) methods
Separating people form processes
Single-use technologies
Environmental monitoring programme
Best practices
Rapid methods
Contamination control strategy
Objectionable organisms
Burkholderia cepacia complex
Quality control during processing and storageJuhiMishra16
describes about microbiological quality criteria and about indicator organisms and their isolation. lays emphasis on GMP and HACCP AND ITS PRINCIPLES. also describes about risk analysis
Quality control measures in pharmaceutical industryChemOnTheGo
QUALITY CONTROL
ROLE OF QUALITY CONTROL IN PHARMACEUTICAL INDUSTRY
OBJECTIVES OF QUALITY CONTROL
STEPS IN QUALITY CONTROL
COST OF QUALITY CONTROL
TOTAL QUALITY MANAGEMENT
QUALITY CIRCLE
Good Manufacturing Practice is a part of quality assurance which ensure that the products are consistently produced and controlled according to quality standards appropriate to their intended use.
Pharmaceutical Microbiology: Current and Future Challenges Tim Sandle, Ph.D.
The changing environment for pharmaceutical microbiology
Limitations of methods
Need for new (rapid) methods
Separating people form processes
Single-use technologies
Environmental monitoring programme
Best practices
Rapid methods
Contamination control strategy
Objectionable organisms
Burkholderia cepacia complex
The objective of the project is fabrication of an off-road vehicle. It
contains various parts like roll cage, braking, suspension, engine,
steering, wheel assembly, braking, transmission etc. In fabrication
process we assemble all parts together.
The objective of our project is to fabricate an All-Terrain Vehicle. The
main purpose is to fabricate a single sitter high-performance and safe
vehicle that will take the ruggedness of rough roads with maximum
safety and driver comfort. This project provides an in-detail
description of the fabrication of an ATV vehicle. Components used in
fabrication are chosen according to their availability and reliability.
This report aims to fabricate an ALL-TERRAIN vehicle (ATV) by the
SAE BAJA 2021 rulebook
Hamdard Laboratories (India), is a Unani pharmaceutical company in India (following the independence of India from Britain, "Hamdard" Unani branches were established in Bangladesh (erstwhile East Pakistan) and Pakistan). It was established in 1906 by Hakeem Hafiz Abdul Majeed in Delhi, and became
a waqf (non-profitable trust) in 1948. It is associated with Hamdard Foundation, a charitable educational trust.
Hamdard' is a compound word derived from Persian, which combines the words 'hum' (used in the sense of 'companion') and 'dard' (meaning 'pain'). 'Hamdard' thus means 'a companion in pain' and 'sympathizer in suffering'.
The goals of Hamdard were lofty; easing the suffering of the sick with healing herbs. With a simple tenet that no one has ever become poor by giving, Hakeem Abdul Majeed let the whole world find compassion in him.
They had always maintained that working in old, traditional ways would not be entirely fruitful. A broader outlook was essential for a continued and meaningful existence. their effective team at Hamdard helped the system gain its pride of place and thus they made an entry into an expansive world of discovery and research.
Hamdard Laboratories was founded in 1906 in Delhi by Hakeem Hafiz Abdul Majeed and Ansarullah Tabani, a Unani practitioner. The name Hamdard means "companion in suffering" in Urdu language.(itself borrowed from Persian) Hakim Hafiz Abdul Majeed was born in Pilibhit City UP, India in 1883 to Sheikh Rahim Bakhsh. He is said to have learnt the complete Quran Sharif by heart. He also studied the origin of Urdu and Persian languages. Subsequently, he acquired the highest degree in the unani system of medicine.
Hakim Hafiz Abdul Majeed got in touch with Hakim Zamal Khan, who had a keen interest in herbs and was famous for identifying medicinal plants. Having consulted with his wife, Abdul Majeed set up a herbal shop at Hauz Qazi in Delhi in 1906 and started to produce herbal medicine there. In 1920 the small herbal shop turned into a full-fledged production house.
Hamdard Foundation was created in 1964 to disburse the profits of the company to promote the interests of the society. All the profits of the company go to the foundation.
After Abdul Majeed's death, his son Hakeem Abdul Hameed took over the administration of Hamdard Laboratories at the age of fourteen.
Even with humble beginnings, the goals of Hamdard were lofty; easing the suffering of the sick with healing herbs. With a simple tenet that no one has ever become poor by giving, Hakeem Abdul Majeed let the whole world find compassion in him. Unfortunately, he passed away quite early but his wife, Rabia Begum, with the support of her son, Hakeem Abdul Hameed, not only kept the institution in existence but also expanded it. As he grew up, Hakeem Abdul Hameed took on all responsibilities. After helping with his younger brother's upbringing and education, he included him in running the institution. Both brothers Hakeem Abdul Hameed and Hakim Mohammed
Roti Bank Hyderabad: A Beacon of Hope and NourishmentRoti Bank
One of the top cities of India, Hyderabad is the capital of Telangana and home to some of the biggest companies. But the other aspect of the city is a huge chunk of population that is even deprived of the food and shelter. There are many people in Hyderabad that are not having access to
Vietnam Mushroom Market Growth, Demand and Challenges of the Key Industry Pla...IMARC Group
The Vietnam mushroom market size is projected to exhibit a growth rate (CAGR) of 6.52% during 2024-2032.
More Info:- https://www.imarcgroup.com/vietnam-mushroom-market
Ang Chong Yi Navigating Singaporean Flavors: A Journey from Cultural Heritage...Ang Chong Yi
In the heart of Singapore, where tradition meets modernity, He embarks on a culinary adventure that transcends borders. His mission? Ang Chong Yi Exploring the Cultural Heritage and Identity in Singaporean Cuisine. To explore the rich tapestry of flavours that define Singaporean cuisine while embracing innovative plant-based approaches. Join us as we follow his footsteps through bustling markets, hidden hawker stalls, and vibrant street corners.
Food and beverage service Restaurant Services notes V1.pptx
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.