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, explaining that GLP was created by the FDA in the 1970s after investigations found fraudulent activities and poor practices in toxicology labs. The objectives of GLP are to ensure data submitted are an accurate reflection of study results and that data is traceable. GLP provides a framework for planning, conducting, monitoring, recording and reporting laboratory studies while maintaining quality assurance.
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.
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.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development. ICH’s mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. On 23 October 2015, ICH announced organisational changes as it marks 25 years of successful harmonisation.
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.
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.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development. ICH’s mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. On 23 October 2015, ICH announced organisational changes as it marks 25 years of successful harmonisation.
GOOD LABORATORY PRACTICES - A DETAILED STUDYTeny Thomas
A detailed study of the rules, regulations and guidelines of Good Laboratory Practices that should be practiced while conducting a Non Clinical Laboratory Study in Animals.
The European Medicines Agency's (EMAs) Committee for herbal medicinal products for human and veterinary use prepares scientific guidelines in consultation with
regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing authorization applications for human and veterinary medicines.
General Principles of Analytical Method of Validation.pdfTamannaKumari8
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, activity carried out in
testing and then production maintain the desirable level of compliance all stages.
The process of providing the analytical procedure is acceptable or its intended us.(ICH Q
GOOD LABORATORY PRACTICES - A DETAILED STUDYTeny Thomas
A detailed study of the rules, regulations and guidelines of Good Laboratory Practices that should be practiced while conducting a Non Clinical Laboratory Study in Animals.
The European Medicines Agency's (EMAs) Committee for herbal medicinal products for human and veterinary use prepares scientific guidelines in consultation with
regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing authorization applications for human and veterinary medicines.
General Principles of Analytical Method of Validation.pdfTamannaKumari8
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, activity carried out in
testing and then production maintain the desirable level of compliance all stages.
The process of providing the analytical procedure is acceptable or its intended us.(ICH Q
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.
Good Laboratory Practices (GLP) and USP 1058 Validation.pdfConference Panel
This webinar will define what is the US FDA's expectations for proper laboratory practices, systems, equipment usage, and documentation / record-keeping. It will evaluate the requirements for how basic Quality Management System (QMS) expectations/requirements are addressed in the lab environment. The webinar with evaluate pharma GMPs and 21 CFR 58 and associated regulations to see how the GLPs can be implemented in the real world to achieve FDA requirements and ensure the accuracy and repeatability/reproducibility of lab results.
This webinar is intended to provide guidance regarding Good Laboratory Practices (GMP) and lab equipment and analytical methods validation for use in pharmaceutical manufacturing and clinical trials and for use by contract laboratories that support the regulated medical products industries.
Register,
https://conferencepanel.com/conference/good-laboratory-practices-glp-and-usp-1058-validation
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
Students, digital devices and success - Andreas Schleicher - 27 May 2024..pptxEduSkills OECD
Andreas Schleicher presents at the OECD webinar ‘Digital devices in schools: detrimental distraction or secret to success?’ on 27 May 2024. The presentation was based on findings from PISA 2022 results and the webinar helped launch the PISA in Focus ‘Managing screen time: How to protect and equip students against distraction’ https://www.oecd-ilibrary.org/education/managing-screen-time_7c225af4-en and the OECD Education Policy Perspective ‘Students, digital devices and success’ can be found here - https://oe.cd/il/5yV
The Art Pastor's Guide to Sabbath | Steve ThomasonSteve Thomason
What is the purpose of the Sabbath Law in the Torah. It is interesting to compare how the context of the law shifts from Exodus to Deuteronomy. Who gets to rest, and why?
This is a presentation by Dada Robert in a Your Skill Boost masterclass organised by the Excellence Foundation for South Sudan (EFSS) on Saturday, the 25th and Sunday, the 26th of May 2024.
He discussed the concept of quality improvement, emphasizing its applicability to various aspects of life, including personal, project, and program improvements. He defined quality as doing the right thing at the right time in the right way to achieve the best possible results and discussed the concept of the "gap" between what we know and what we do, and how this gap represents the areas we need to improve. He explained the scientific approach to quality improvement, which involves systematic performance analysis, testing and learning, and implementing change ideas. He also highlighted the importance of client focus and a team approach to quality improvement.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
Ethnobotany and Ethnopharmacology:
Ethnobotany in herbal drug evaluation,
Impact of Ethnobotany in traditional medicine,
New development in herbals,
Bio-prospecting tools for drug discovery,
Role of Ethnopharmacology in drug evaluation,
Reverse Pharmacology.
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