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Printable Handouts
Navigable Slide Index
- Introduction
- Agenda
- What are principles of GLP
- Scope
- Areas of expertise
- GLP across globe
- Why GLP?
- Elements of GLP principles
- Roles and responsibilities
- Test facility management responsibilities (1)
- Test facility management responsibilities (2)
- Test facility management responsibilities (3)
- Quality assurance
- Quality assurance unit
- Types of inspections
- Facility-based inspection
- Process-based inspection
- Study-based inspection
- Quality assurance: QA statement
- Why we need a study director
- Study director responsibilities (1)
- Study director responsibilities (2)
- Study personnel (1)
- Study personnel (2)
- ALCOA+
- Facilities
- Test system facilities
- Test item facilities
- Archives
- Waste disposal
- Apparatus
- Materials and reagents
- Test system
- Physical/chemical test system
- Biological test system (1)
- Biological test system (2)
- Test and reference item
- Identification and characterization
- Characterization
- Standard Operating Procedures (SOP)
- SOP
- Performance of study
- Content of study plan
- Conduct of study
- Reporting of results
- Content of study report
- Archive
- Storage and retention of records and materials
- Facility specific records
- Challenge questions
- Challenge question #1
- Challenge question #2
- Challenge question #3
- Challenge question #4
- Challenge question #5
- Thank you
Topics Covered
- Principles of good laboratory practice (GLP)
- Scope and areas of expertise
- The need for GLP
- Elements of GLP principles
- Associated roles and responsibilities
Links
Categories:
External Links
Talk Citation
Baweja, J. (2023, December 31). OECD principles on good laboratory practice (GLP): OECD Document No. 1 [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved December 5, 2024, from https://doi.org/10.69645/FZMT3811.Export Citation (RIS)
Publication History
Financial Disclosures
- There are no commercial/financial matters to disclose.
A selection of talks on Pharmaceutical Sciences
Transcript
Please wait while the transcript is being prepared...
0:00
Hello everyone. This
is Jyoti Baweja.
I'm a toxicologist, a certified
GLP professional, GLP consultant,
and an active member of the
Society of Quality Assurance
and GLP Specialty
Section Committee
United States with an
experience of around 23 years.
Today we would be going
through the topic,
the OECD Principles on
Good Laboratory Practice,
which is document number
one in the OECD series on
Principles of Good
Laboratory Practice
and Compliance Monitoring.
0:34
Let us start with the
agenda for the session.
This session will
comprehend what
are the principles of good
laboratory practice or GLP?
What is the scope and
areas of expertise which
comes under the preview of the
application of
principles of GLP?
Why do we need Good
Laboratory Practice?
The various important
elements of
GLP principles and
the associated roles
and responsibilities
of key personnel who
are involved in the compliance
with the GLP principles.
1:10
What are the principles of
Good Laboratory Practice?
These are a set of managerial
quality control systems,
which is developed by the
Organization for Economic
Cooperation and Development,
that's OECD,
covering all the
organizational processes
and conditions under
which any non clinical
health and environment
safety study is planned,
performed, monitored, recorded,
reported, and archived.
Notable point is that
the OECD principles
of GLP concern non
clinical testing,
indicating that they should not
include human subjects
for any reason.
Furthermore, they
do involve work
which is conducted in
greenhouses and in the feed,
for example, we have it
when we have the
pesticide testing.
It is important to
understand that
good laboratory
practices does not
assess the intrinsic
scientific value
or technical validity
of the studies,
which is a part to
be played by the
regulatory or as we call them
as receiving authorities.
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