The document discusses the OECD Principles of Good Laboratory Practice (GLP). It begins with an introduction to GLP and why it was created due to issues of poor laboratory practices discovered by the FDA in the 1970s. It then discusses the scope and principles of GLP established by the OECD, including test facility organization, quality assurance programs, facilities, equipment and materials, test systems, test and reference items, standard operating procedures, study conduct, reporting and storage. The principles are intended to ensure safety data from nonclinical studies are reliable and of high quality.
OECD principles of Good laboratory practice. this ppt include the basic and necessary information required for OECD GLP guideline . Content is taken from official site
Dermal Irritation and Dermal Toxicity Studies Dinesh Gangoda
Dermal irritation and Corrosion test guidelines 204.
Dermal irritation is the production of reversible damage of the skin following the application of a test chemical for up to 4 hours.
Corrosive reactions are typified by ulcers, bleeding, bloody scabs, and, by the end of observation at 14 days, by discolouration due to blanching of the skin, complete areas of alopecia, and scars. Histopathology should be considered to evaluate questionable lesions. [1]
Dermal corrosion is the production of irreversible damage of the skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test chemical for up to four hours.[2]
REFERENCES
OECD/OCDE, Test No. 404: ‘‘Acute Dermal Irritation/Corrosion’’, 28 July 2015 OECD Publishing, peris, Page no, 1- 8.
Robert A., Turner., Screening Methods in Pharmacology; 1st edition; Academic press an imprint of Elsevier, pp, 279- 281.
OECD Guideline for testing of chemicals (1981). ‘‘Repeated Dose Dermal Toxicity’’, 21/28- day Study.
Origin and principles of international conference on harmonization- Good clin...AbhishekJoshi312
The ppt gives a basic information about ICH-GCP, how it originated , what led to the formation of ICH-GCP guidelines and what are the principles of the guidelines.
This presentation enlists all the studies which are required before submission of IND. It include IND introduction , time period of study ,flowchart showing preclinical studies...
Alternative methods to animals testing are the development and implementation of test method that avoid use of live animals or use of less animals in method.
The council directive on protection of animals used for experiments and scientific purpose in article 23
“The commission and member states should encourage
research into development and validation of alternative methods which could provide the same level of information as that obtained in experiment using animals but which involves less animal”.
Alternative methods able to do:
Reduce Refine Replace
collectively called as “The 3Rs Principle”.
Needs for alternative methods
Because in laboratory animals may be:
Poisoned.
Deprived of food water and sleep.
Applied with skin and eye irritants.
Subjected to psychological stress.
Deliberately infected with the infected disease.
OECD principles of Good laboratory practice. this ppt include the basic and necessary information required for OECD GLP guideline . Content is taken from official site
Dermal Irritation and Dermal Toxicity Studies Dinesh Gangoda
Dermal irritation and Corrosion test guidelines 204.
Dermal irritation is the production of reversible damage of the skin following the application of a test chemical for up to 4 hours.
Corrosive reactions are typified by ulcers, bleeding, bloody scabs, and, by the end of observation at 14 days, by discolouration due to blanching of the skin, complete areas of alopecia, and scars. Histopathology should be considered to evaluate questionable lesions. [1]
Dermal corrosion is the production of irreversible damage of the skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test chemical for up to four hours.[2]
REFERENCES
OECD/OCDE, Test No. 404: ‘‘Acute Dermal Irritation/Corrosion’’, 28 July 2015 OECD Publishing, peris, Page no, 1- 8.
Robert A., Turner., Screening Methods in Pharmacology; 1st edition; Academic press an imprint of Elsevier, pp, 279- 281.
OECD Guideline for testing of chemicals (1981). ‘‘Repeated Dose Dermal Toxicity’’, 21/28- day Study.
Origin and principles of international conference on harmonization- Good clin...AbhishekJoshi312
The ppt gives a basic information about ICH-GCP, how it originated , what led to the formation of ICH-GCP guidelines and what are the principles of the guidelines.
This presentation enlists all the studies which are required before submission of IND. It include IND introduction , time period of study ,flowchart showing preclinical studies...
Alternative methods to animals testing are the development and implementation of test method that avoid use of live animals or use of less animals in method.
The council directive on protection of animals used for experiments and scientific purpose in article 23
“The commission and member states should encourage
research into development and validation of alternative methods which could provide the same level of information as that obtained in experiment using animals but which involves less animal”.
Alternative methods able to do:
Reduce Refine Replace
collectively called as “The 3Rs Principle”.
Needs for alternative methods
Because in laboratory animals may be:
Poisoned.
Deprived of food water and sleep.
Applied with skin and eye irritants.
Subjected to psychological stress.
Deliberately infected with the infected disease.
The fundamental purposes of the Principles of Good Laboratory Practice (GLP) is to ensure the quality and integrity of test data related to non-clinical safety studies.
Good Laborarory Practices. Good Laboratory Practices (GLP) covers the organizational process and conditions under which clinical field studies are conducted, monitored, recorded and reported. GLP is carried out to improve quality of data for its international acceptance.
Good Laboratory Practices (GLP)
History
Reason behind GLP created
Advantages and disadvantages of GLP
Objectives of GLP
Practice of GLP
b pharma 6th sem
pharmaceutical quality assurance
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
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ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
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Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Oecd principles of good laboratory practices (glp)
1. OECD PRINCIPLES OF GOOD
LABORATORY PRACTICES (GLP)
PRESENTED BY:
M. Sri Ram
I/II M. Pharmacy
Y20MPH03050
Department of Pharmacology
University college of Pharmaceutical sciences,
Acharya nagarjuna university, Guntur.
UNDER THE GUIDENCE OF
Dr. k. Phani Kumar
M. Pharm, Ph.D.,
Dr. D. Ravi Chandra Shekar Reddy
M. Pharm, Ph.D.,
1
3. 1.GOOD LABORATORY PRACTICE
• GLP applies to nonclinical studies conducted for the assessment of the safety or
efficacy of chemicals (including pharmaceuticals).
• GLP helps assure regulatory authorities that the data submitted are a true.
• The formal regulatory concept of “good laboratory practice” (GLP) originated in
the USA in the 1970’s.
• The FDA's publication of proposed regulations on GLP in 1976, with
establishment of the final rule in june 1979 (21 CFR 58).
• In 1981 an organization named OECD produced GLP principles that are
international standard.
3
4. Why was GLP created?
• In the early 70’s FDA became aware of cases of ( PLP ) poor laboratory practice
all over the united states.
• FDA decided to do an in-depth investigation in 40 toxicology labs.
• They discovered a lot fraudulent activities and a lot of poor lab practices.
Examples of some of these ( PLP ) poor lab practices found were:
• Equipment not been calibrated to standard form , therefore giving wrong
measurements.
• Incorrect/inaccurate accounts of the actual lab study.
• Inadequate plan.
4
5. FAMOUS EXAMPLE
• One of the labs that went under such an investigation made headline
news.
• The name of the lab was industrial bio test.
• This was a big lab that ran tests for big companies such as
Procter and gamble (P&G)
• It was discovered that mice that they had used to test lotion and deodorants had
developed cancer and died.
• Industrial bio test lab threw the dead mice and covered results deeming the products
good for human use.
• Those involved in production, distribution and sales for the IBT lab eventually served
jail time.
5
6. ABOUT THE OECD
• The organization for economic co-operation and development (OECD) is an
intergovernmental organization in which representatives of 29 industrialised
countries in north America, Europe and the pacific, as well as the European
commission, meet to co-ordinate and harmonize policies, discuss issues of mutual
concern, and work together to respond to international problems.
• Most of the OECD's work is carried out by more than 200 specialized committees
and subsidiary groups composed of member country delegates. Observers from
several countries with special status at the OECD, and from interested international
organizations, attend many of the OECD's workshops and other meetings.
6
7. • Committees and subsidiary groups are served by the OECD secretariat, located in
Paris, France, which is organized into directorates and divisions.
• The work of the OECD related to chemical safety is carried out in the environmental
health and safety division.
• The environmental health and safety division publishes free-of charge documents in
six different series: testing and assessment; principles on good laboratory practice
and compliance monitoring; pesticides; risk management; chemical accidents and
harmonization of regulatory oversight in biotechnology.
• More information about the environmental health and safety programme and EHS
publications is available on OECD's world wide web site.
• The OECD principles of good laboratory practice were first developed by an expert
group on GLP established in 1978 under the special programme on the control of
chemicals. 7
8. • The GLP regulations for non-clinical laboratory studies published by the US food
and drug administration in 1976 provided the basis for the work of the expert group,
which was led by the united states and comprised experts from the following
countries and organisations: Australia, Austria, Belgium, Canada, Denmark,
France, the federal republic of Germany, Greece, Italy, Japan, The Netherlands,
New Zealand, Norway, Sweden, Switzerland, The United Kingdom, The United
States, the commission of the European communities, the world health
organisation and the international organisation for standardization.
• Those principles of GLP were formally recommended for use in member countries
by the OECD council in 1981.
8
9. • They were set out (in annex II) as an integral part of the council decision on mutual
acceptance of data in the assessment of chemicals, which states that “data generated
in the testing of chemicals in an OECD member country in accordance with OECD
test guidelines”and OECD principles of good laboratory practice shall be accepted in
other member countries for purposes of assessment and other uses relating to the
protection of man and the environment ”
9
10. SCOPE
• These principles of good laboratory practice should be applied to the non-clinical
safety testing of test items contained in pharmaceutical products, pesticide products,
cosmetic products, veterinary drugs as well as food additives, feed additives, and
industrial chemicals.
• These test items are frequently synthetic chemicals, but may be of natural or
biological origin and, in some circumstances, may be living organisms. The purpose
of testing these test items is to obtain data on their properties and/or their safety
with respect to human health and/or the environment.
• Non-clinical health and environmental safety studies covered by the principles of
good laboratory practice include work conducted in the laboratory, in greenhouses,
and in the field.
10
11. • Unless specifically exempted by national legislation, these principles of good
laboratory practice apply to all non-clinical health and environmental safety
studies required by regulations for the purpose of registering or licensing
pharmaceuticals, pesticides, food and feed additives, cosmetic products,
veterinary drug products and similar products, and for the regulation of industrial
chemicals.
11
12. GOOD LABORATORY PRACTICE PRINCIPLES
A.Test Facility Organisation and Personnel
1.1 Test facility management’s responsibilities
1. Each test facility management should ensure that these principles of good laboratory
practice are complied with, in its test facility.
2. At a minimum it should:
a) Ensure that a statement exists which identifies the individual(s) within a test facility
who fulfil the responsibilities of management as defined by these principles of good
laboratory practice;
b) Ensure that a sufficient number of qualified personnel, appropriate facilities,
equipment, and materials are available for the timely and proper conduct of the study;
12
13. C) Ensure the maintenance of a record of the qualifications, training, experience and job
description for each professional and technical individual;
D) Ensure that personnel clearly understand the functions they are to perform and, where
necessary, provide training for these functions;
E) Ensure that appropriate and technically valid standard operating procedures are
established and followed, and approve all original and revised standard operating
procedures;
F) Ensure that there is a quality assurance programme with designated personnel and
assure that the quality assurance responsibility is being performed in accordance with
these principles of good laboratory practice;
13
14. G) Ensure that for each study an individual with the appropriate qualifications,
training, and experience is designated by the management as the study director
before the study is initiated. Replacement of a study director should be done
according to established procedures and should be documented.
H) Ensure, in the event of a multi-site study, that, if needed, a principal investigator
is designated, who is appropriately trained, qualified and experienced to supervise
the delegated phase(s) of the study. Replacement of a principal investigator should
be done according to established procedures and should be documented.
I) Ensure documented approval of the study plan by the study director.
14
15. 1.2 study director’s responsibilities:
• The study director has the responsibility for the overall conduct of the study and for its
final report.
• Approve the study plan and any amendments to the study plan by dated signature
• Ensure that all raw data generated are fully documented and recorded
• Ensure that the procedures specified in the study plan are followed, and assess and
document the impact of any deviations from the study plan on the quality and integrity of
the study, and take appropriate corrective action if necessary; acknowledge deviations
from standard operating procedures during the conduct of the study.
• Ensure that computerized systems used in the study have been validated.
15
16. 1.3 Principal investigator’s responsibilities:
• The principal investigator will ensure that the delegated phases of the study are
conducted in accordance with the applicable principles of good laboratory practice.
1.4 Study personnel’s responsibilities
• All personnel involved in the conduct of the study must be knowledgeable in those
parts of the principles of good laboratory practice which are applicable to their
involvement in the study.
• Study personnel should exercise health precautions to minimize risk to themselves and
to ensure the integrity of the study. They should communicate to the appropriate person
any relevant known health or medical condition in order that they can be excluded
from operations that may affect the study.
16
17. • All study personnel are responsible for recording raw data promptly and
accurately and in compliance with these principles of good laboratory practice
and are responsible for the quality of their data.
• Study personnel will have access to the study plan and appropriate standard
operating procedures applicable to their involvement in the study. It is their
responsibility to comply with the instructions given in these documents.
17
18. B.) Quality Assurance Programme
2.1 General
The quality assurance programme should be carried out by an individual or by individuals
designated by and directly responsible to management and who are familiar with the test
procedures.
2.2 Responsibilities of the quality assurance personnel
• Maintain copies of all approved study plans and standard operating procedures in use in
the test facility.
• Verify that the study plan contains the information required for compliance with these
principles of good laboratory practice. This verification should be documented.
• Conduct inspections to determine that study plans, and standard operating procedures
have been made available to study personnel and are being followed. 18
19. C.) Facilities
3.1 General
• The test facility should be of suitable size, construction and location to meet the
requirements of the study and to minimize disturbance that would interfere with the
validity of the study.
3.2 Test System Facilities
• There should be storage rooms or areas as needed for supplies and equipment.
• Storage rooms or areas should be separated from rooms or areas housing the test
systems and should provide adequate protection against infestation, contamination,
and/or deterioration.
19
20. The test facility should have a sufficient number of rooms or areas to assure the
isolation of test systems and the isolation of individual projects, involving
substances or organisms known to be or suspected of being biohazardous.
3.3 Facilities for handling test and reference items
To prevent contamination or mix-ups, there should be separate rooms or areas for
receipt and storage of the test and reference items, and mixing of the test items
with a vehicle
3.4 Archive Facilities
Archive facilities should be provided for the secure storage and retrieval of study
plans, raw data, final reports, samples of test items and specimens. Archive design
and archive conditions should protect contents from un-timely deterioration.
20
21. 3.5 Waste Disposal
Handling and disposal of wastes should be carried out in such a way as not to
jeopardise the integrity of studies. This includes provision for appropriate collection,
storage and disposal facilities, and decontamination and transportation procedures.
D.) Apparatus, material, and reagents
• Apparatus, including validated computerized systems, used for the generation,
storage and retrieval of data, and for controlling environmental factors relevant to the
study should be suitably located and of appropriate design and adequate capacity.
• Apparatus and materials used in a study should not interfere adversely with the test
systems.
21
22. • Chemicals, reagents, and solutions should be labelled to indicate identity (with
concentration if appropriate), expiry date and specific storage instructions.
Information concerning source, preparation date and stability should be available. The
expiry date may be extended on the basis of documented evaluation or analysis.
E.) Test system
5.1 Physical/Chemical
• Apparatus used for the generation of physical/chemical data should be suitably located
and of appropriate design and adequate capacity.
5.2 Biological
• Proper conditions should be established and maintained for the storage, housing,
handling and care of biological test systems, in order to ensure the quality of the data.
22
23. • Newly received animal and plant test systems should be isolated until their health
status has been evaluated.
• All information needed to properly identify the test systems should appear on their
housing or containers. Individual test systems that are to be removed from their
housing or containers during the conduct of the study should bear appropriate
identification, wherever possible.
F.) Test And Reference Items
6.1 Receipt, Handling, Sampling And Storage
• Records including test item and reference item characterization, date of receipt,
expiry date, quantities received and used in studies should be maintained.
• Storage container(s) should carry identification information, expiry date, and specific
storage instruction. 23
24. 6.2 characterization
• Each test and reference item should be appropriately identified (e.g., Code, name,
biological parameters).
• The stability of test and reference items under storage and test conditions should be
known for all studies.
G.) Standard operating procedures
7.1: A test facility should have written standard operating procedures approved by test
facility management that are intended to ensure the quality and integrity of the data
generated by that test facility.
7.2: Deviations from standard operating procedures related to the study should be
documented and should be acknowledged by the study director and the principal
investigator(s), as applicable. 24
25. SOP’S must be available for following test facility activities such as:
1. Test And Reference Items
2. Apparatus, Materials And Reagents
3. Record Keeping, Reporting, Storage And Retrieval
4. Test System
5. Quality Assurance Procedures.
25
26. H. Performance of the study
8.1 study plan
• For each study, a written plan should exist prior to the initiation of the study. The
study plan should be approved by dated signature of the study director and verified
for GLP compliance by quality assurance personnel as specified in section 2.2.1.B
• For short-term studies, a general study plan accompanied by a study specific
supplement may be used.
• Amendments to the study plan should be justified and approved by dated signature
of the study director and maintained with the study plan.
26
27. 8.2 Content Of The Study Plan
• Identification of the study, the test item and reference item
• Information concerning the sponsor and the test facility
• Dates, test methods
• Issues and records
8.3 Conduct Of The Study
• A unique identification should be given to each study.
• All data generated during the conduct of the study should be recorded directly,
promptly, accurately, and legibly by the individual entering the data.
• Data generated as a direct computer input should be identified at the time of data input
by the individual(s) responsible for direct data entries. 27
28. I.) Reporting Of Study Results
9.1 General
• A final report should be prepared for each study.
• Reports of principal investigators or scientists involved in the study should be signed
and dated by them.
• Corrections and additions to a final report should be in the form of amendments.
9.2 content of the final report
• Identification of the study, the test item and reference item.
• Information concerning the sponsor and the test facility such as name and address of
the sponsor, study director, principal investigator(s),scientists, and test facilities and
sites. 28
29. • Dates, statement, description of materials and test methods, results and location of all
the reports are to be stored.
J.) Storage and retention of records and materials
10.1 The following should be retained in the archives for the period specified by the
appropriate authorities:
A) The study plan, raw data, samples of test and reference items, specimens, and the final
report of each study;
B) Records of all inspections performed by the quality assurance programme, as well as
master schedules;
C) Records of qualifications, training, experience and job descriptions Of personnel;
D) Records and reports of the maintenance and calibration of apparatus. 29
30. E) Validation documentation for computerised systems
F) The historical file of all standard operating procedures;
G) Environmental monitoring records.
• In the absence of a required retention period, the final disposition of any study
materials should be documented.
• When samples of test and reference items and specimens are disposed of before the
expiry of the required retention period for any reason, this should be justified and
documented. Samples of test and reference items and specimens should be retained
only as long as the quality of the preparation permits evaluation.
30
31. 10.2 Material retained in the archives should be indexed so as to facilitate orderly
storage and retrieval.
10.3 Only personnel authorized by management should have access to the archives.
Movement of material in and out of the archives should be properly recorded.
10.4 If a test facility or an archive contracting facility goes out of business and has
no legal successor, the archive should be transferred to the archives of the
sponsor(s) of the study(s).
31