The document discusses Good Laboratory Practice (GLP), which are quality standards that regulate the conduct of laboratory studies related to health and safety. It provides background on GLP, including that GLP was created by the FDA in the 1970s in response to cases of fraudulent laboratory practices. The key objectives of GLP are to ensure laboratory study data is accurate, traceable, and can be relied upon for regulatory decision making. GLP establishes requirements for facilities, equipment, personnel, methods, records, and management to ensure the integrity of all safety data generated during nonclinical health and environmental safety studies.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCAnupriyaNR
Analytical method qualification consists of a simplified evaluation of a subset of validation characteristics with a goal to demonstrate that an analytical method is scientifically sound and suitable for its intended use. In contrast to validation, analytical method qualification is performed without predefined acceptability criteria. Qualification may be performed as a prerequisite to method validation, or when an assay for product knowledge has not yet been established as a test for a critical product quality attribute. Qualification of equipment is pre-requisite for validation of the process in which the equipment is being used. Many types of equipment have measuring devices on them. Calibration of measuring devices is a part of qualification. Calibration of measuring devices is important, as the data is often collected through them. If the data collected is not from measuring devices that have been calibrated, the data cannot be relied upon. Thus the whole validation exercise can be questioned.
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
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.
Analytical method validation as per ich and usp shreyas B R
Analytical method validation is a process of documenting/ proving that an analytical method provides analytical data acceptable for the intended use.After the development of an analytical procedure, it is must important to assure that the procedure will consistently produce the intended a precise result with high degree of accuracy. The method should give a specific result that may not be affected by external matters. This creates a requirement to validate the analytical procedures. The validation procedures consists of some characteristics parameters that makes the method acceptable with addition of statistical tools.
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCAnupriyaNR
Analytical method qualification consists of a simplified evaluation of a subset of validation characteristics with a goal to demonstrate that an analytical method is scientifically sound and suitable for its intended use. In contrast to validation, analytical method qualification is performed without predefined acceptability criteria. Qualification may be performed as a prerequisite to method validation, or when an assay for product knowledge has not yet been established as a test for a critical product quality attribute. Qualification of equipment is pre-requisite for validation of the process in which the equipment is being used. Many types of equipment have measuring devices on them. Calibration of measuring devices is a part of qualification. Calibration of measuring devices is important, as the data is often collected through them. If the data collected is not from measuring devices that have been calibrated, the data cannot be relied upon. Thus the whole validation exercise can be questioned.
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
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.
Analytical method validation as per ich and usp shreyas B R
Analytical method validation is a process of documenting/ proving that an analytical method provides analytical data acceptable for the intended use.After the development of an analytical procedure, it is must important to assure that the procedure will consistently produce the intended a precise result with high degree of accuracy. The method should give a specific result that may not be affected by external matters. This creates a requirement to validate the analytical procedures. The validation procedures consists of some characteristics parameters that makes the method acceptable with addition of statistical tools.
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
Good Laboratory Practices (GLPs) are standard regulatory programs that assure the quality and integrity of nonclinical safety test data submitted to regulatory agencies worldwide.
Good Laboratory Practices (GLPs) are standard regulatory programs that assure the quality and integrity of nonclinical safety test data submitted to regulatory agencies worldwide.
1) GLP embodies a set of principles that provides a frame work within which laboratory studies are planned performed, monitored, and archived and reported.
2) WHY WAS GLP CREATED? • In the early 70’s FDA became aware of cases of poor laboratory practice all over the United States. • They discovered a lot fraudulent activities and a lot of poor lab practices. • Examples of some of these poor lab practices found were 1. Equipment not been calibrated to standard form , therefore giving wrong measurements. 2. Incorrect/inaccurate accounts of the actual lab study. 3. Inadequate test systems.
3) Purpose of GLPs: • GLP is to certify that every step of the analysis is valid or Not. • Assure the quality & integrity of data submitted to FDA in support of the safety of regulated products. • GLPs have heavy emphasis on data recording, record & specimen retention.
4)GOOD LABORATORY PRACTICES PRINCIPLES. 1. Test Facility Organisation and Personnel. 2. Quality Assurance Programme(QAP). 3. Facilities. 4. Apparatus, Material and Reagents. 5. Test systems. 6. Test and Reference Substances. 7. Standard Operating Procedures(SOP). 8. Performance of The Study. 9. Reporting of Study Results. 10. Storage and Retention of Records and materials.
5) GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies.
6) "Good Laboratory Practice", or GLP for short, refers to a quality assurance system that is applied during the pre-clinical stage of research and development. Its aim is to test active ingredients under specific environmental conditions and over a defined period of time.
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elements required for inform consent form
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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.
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Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
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
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These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
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2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
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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.
2. GLP is an FDA regulation.
Definition: GLP embodies a set of principles
that provides a framework within which
laboratory studies are planned performed,
monitored, reported and archived.
GLP is sometimes confused with the standards
of laboratory safety like wearing, safety
goggles. etc..
2
3. HISTORY
GLP is a formal regulation that was created by
the FDA (United states food and drug
administration) in 1978.
In 1981 an organization named OECD
(organization for economic co-operation and
development ) produced GLP principles that
are international standard.
3
4. WHY WAS GLP CREATED..??
In the early 70’s FDA became aware of cases of poor
laboratory practice all over the United States.
FDA decided to do an in-depth investigation on 40
toxicology labs.
They discovered a lot fraudulent activities and a lot of
poor lab practices.
Examples of some of these poor lab practices found
were
1. Equipment not been calibrated to standard form ,
therefore giving wrong measurements.
2. Incorrect/inaccurate accounts of the actual lab study.
3. Inadequate test systems.
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.
It was discovered that mice that
they had used to test cosmetics such
as 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 consumption.
Those involved in production,
distribution and sales for the lab
eventually served jail time 5
6. OBJECTIVES OF GLP
GLP makes sure that the data submitted are a
true reflection of the results that are obtained
during the study.
GLP also makes sure that data is traceable.
Promotes international acceptance of tests.
6
7. What is GLP..??
• Good Laboratory Practice is an essential part
of Good Manufacturing Practice detailed in
Schedule M to the Drugs & Cosmetic Rule.
• It involves a number of good practices in the
Quality Control laboratory which are to be
undertaken to carry out an analysis with a
defined degree of Accuracy & Precision
7
8. GMP vs. GLP
• Samples Laboratory
Processes
Results of
Analysis
Good Laboratory Practices
Raw Materials
Packaging
Materials
Manufacturing
Processes
Finished Product
of Standard
Quality
Good Manufacturing Practices
8
9. The Purpose of a Laboratory
Quality Assurance Program
• The purpose of the quality assurance program is
to assure that all laboratory testing is performed
according to the principles of current Good
Laboratory Practice (cGLP).
• This is carried out by the quality assurance
department which has the authority to authorize
all quality related documentation.
• The quality assurance department is staffed by
individuals who are knowledgeable of, and
familiar with, the laboratory testing.
9
10. Quality Assurance; Establishing
Confidence in Reported Data
• Elements of Good Laboratory Practice
Standard Operating Procedures (SOP's).
Statistical procedures for data evaluation
Instrumentation validation
Reagent/materials certification
Analyst certification
Lab facilities certification
Specimen/Sample tracking
10
11. Standard Operating Procedures
(SOP)
Written procedures for a laboratories
program.
They define how to carry out protocol-
specified activities.
Most often written in a chronological listing of
action steps.
They are written to explain how the
procedures are suppose to work
11
12. SOP
Routine inspection, cleaning, maintenance,
testing and calibration.
Actions to be taken in response to equipment
failure.
Analytical methods
Definition of raw data
Keeping records, reporting, storage, mixing,
and retrieval of data
12
13. Statistical Procedures For Data
Evaluation
Statistical procedures are not simply chosen
from a text book
Practitioners in a particular field may adopt
certain standards which are deemed acceptable
within that field.
Regulatory agencies often describe acceptable
statistical procedures
13
14. Instrumentation Validation
• This is a process necessary for any analytical
laboratory.
• Data produced by “faulty” instruments may give
the appearance of valid data.
• The frequency for calibration, re-validation and
testing depends on the instrument and extent of its
use in the laboratory.
• Whenever an instrument’s performance is outside
the “control limits” reports must be discontinued
14
15. Instrument Validation (cont)
Equipment records should include:
1. Name of the equipment and manufacturer
2. Model or type for identification
3. Serial number
4. Date equipment was received in the
laboratory
5. Copy of manufacturers operating instruction
15
16. Reagent/ Materials Certification
This policy is to assure that reagents used are
specified in the standard operating procedure.
Purchasing and testing should be handled by a
quality assurance program.
16
17. Reagents And Solutions (cont)
Requirements:
• Reagents and solutions shall be labeled
• Deteriorated or outdated reagents and solutions
shall not be used
• Include Date opened
• Stored under ambient temperature
• Expiration date
17
18. Analyst Certification
Some acceptable proof of satisfactory training
and/or competence with specific laboratory
procedures must be established for each
analyst.
Qualification can come from education,
experience or additional trainings, but it should
be documented
Sufficient people
Requirements of certification vary
18
19. Laboratory Certification
Normally done by an external agency
Evaluation is concerned with issues such as
Adequate space
Ventilation
Storage
Hygiene
19
20. Specimen/Sample Tracking
Vary among laboratories
Must maintain the unmistakable connection
between a set of analytical data and the
specimen and/or samples from which they
were obtained.
Original source of specimen/sample (s) must
be recorded and unmistakably connected with
the set of analytical
20
21. Documentation And Maintenance of
Records
Maintenance of all records provide
documentation which may be required in the
event of legal challenges due to repercussions of
decisions based on the original analytical results.
General guidelines followed in regulated
laboratories is to maintain records for at least five
years
Length of time over which laboratory records
should be maintained will vary with the situation
21
22. Documentation & Records
•Usual Document and records with which Q.C Laboratory has to
deal with are –
Specification
Test Procedure
Standard Operating Procedures
Certificate of Analysis with relevant Test Protocols
Sample Register
Register for Reference Standards & Reference Cultures
Calibration Records
Validation Records
Training Records
22
23. Documents And Records (cont)
Records for Retained samples (Both finished products
& active raw materials)
Records pertaining to the preparation of solutions of
reference standards, volumetric solutions and other
reagents.
Log book for instruments & equipment's.
All documents are to be reviewed periodically and
updated whenever required.
Records should be maintained in such a manner that
these are always traceable.
If required help of electronic data processing system
may be taken.
23
25. Disqualification Of A Facility
Before a workplace can experience the
consequences of noncompliance, an
explanation of disqualification is needed
The FDA states the purpose of disqualification
as the exclusion of a testing facility from
completing laboratory studies or starting any
new studies due to not following the standards
of compliance set by the Good Laboratory
Practice manual
25
26. Grounds For Disqualification
The testing facility failed to comply with one
or more regulations implemented by the GLP
manual
The failure to comply led to adverse outcomes
in the data; in other words, it affected the
validity of the study
Warnings or rejection of previous studies have
not been adequate to improve the facility’s
compliance
26
27. Consequences Of Noncompliance
The FDA states the following consequences of noncompliance:
• The commissioner will send a written proposal of
disqualification to the testing facility
• A regulatory hearing on the disqualification will be
scheduled
• If the commissioner finds that after the hearing, the
facility has complied, then a written statement with an
explanation of termination of disqualification will be sent
to the facility
• Thus, if it can be shown that such disqualifications did not
affect the integrity and outcome of the study itself, or did
not occur at all, then the study may be reinstated at the
will of the commissioner. 27
28. Upon Disqualification…
If the commissioner finds that the facility was
noncompliant on any of the grounds after the hearing, then
a final order of noncompliance will be sent to the facility
with explanations :
1. If a testing facility has been disqualified, any studies done
before of after the disqualification will need to be
determined as essential to a decision (acceptable or not)
2. If the study is determined unacceptable, then the facility
itself may need to show that the study was not affected by
the noncompliance that led to the disqualification
3. Once finally disqualified, the facility may not receive or
be considered for a research or marketing permit and the
study is rejected. 28
29. Upon Disqualification
• The FDA may turn it over to the federal, state
or local law enforcement
• The facility’s sponsor may terminate or
suspend the facility from doing any non-
clinical study for a permit.
• The sponsor is required to notify the FDA in
writing within 15 working days that the facility
is to be suspended or terminated.
29
30. Reinstatement Of A Disqualified
Facility
• The disqualified facility will be required to put in
writing to the commissioner reasons why it should
be reinstated and any actions the facility will take
or have taken to assure any disqualification
problems will not happen again
1. The commissioner will inspect the facility and
determine if it shall be reinstated
2. If it is reinstated, the commissioner is required to
notify all persons that were notified of the
disqualification including the facility itself .
30
31. CONCLUSION
• In conclusion one must realize that in the
pharmaceutical industry there is no margin for
error and one must follow good practices in the
laboratory to generate accurate, precise and
reliable data.
31