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GLP TRAINING
General
Wayne Jiang, PhD
IR-4, Michigan State University, jiangwa@msu.edu
Michael Braverman, PhD
IR-4 Headquarters, Rutgers University
Information
General Terms
GLP Good Laboratory Practices
GMP Good Manufacturing Practices GMP Good Manufacturing Practices
GCP Good Clinical Practices
Protocol (or Work Plan)
A document which clearly indicates the objectives and
methods for the conduct of the study
General Terms
SOPs
Set of Standard Operating Procedures
Working Methods
Individual working methods
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General Terms
EPA
Environmental Protection Agency
FDA FDA
Food and Drug Administration
OECD
Organization for Economic
Co-operation and Development
General Terms
SD
Study Director
FRD and LRD FRD and LRD
Field Research Director
Laboratory Research Director
QA
Quality Assurance
Definitions
Good Laboratory Practice
Good Laboratory Practice (GLP) is a quality
system with the organizational process and y g p
the conditions under which non-clinical
health and environmental safety studies are
planned, performed, monitored, recorded,
archived and reported.
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Definitions
Nonclinical laboratory study
In vivo or in vitro experiments in which test
articles are studied prospectively in test systems
under laboratory conditions to determine their under laboratory conditions to determine their
safety. The term does not include studies
utilizing human subjects or clinical studies or field
trials in animals. The term does not include basic
exploratory studies carried out to determine
whether a test article has any potential utility or to
determine physical or chemical characteristics of
a test article.
21 CFR Part 58.3(d)
Definitions
Sponsor
A person who initiates and supports, by
provision of financial or other resources, a
nonclinical laboratory study; nonclinical laboratory study;
A person who submits a nonclinical study to
the FDA in support of an application for a
research or marketing permit; or
A testing facility, if it both initiates and actually
conducts the study.
21 CFR Part 58.3(f)(1)(2)(3)
Definitions
Testing Facility
A person who actually conducts a nonclinical
laboratory study, i.e., actually uses the test
article in a test system.
21 CFR Part 58.3(g)
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Definitions
Quality Assurance Unit (QAU)
Any person or organizational element, except
the study director, designated by testing
facility management to perform the duties
relating to quality assurance of nonclinical
laboratory studies.
21 CFR Part 58.3(l)
Definitions
Standard Operating Procedures
Documented procedures which describe how
to perform tests or activities normally not
ifi d i d t il i t d l t t specified in detail in study plans or test
guidelines
Definitions
Study Director (SD)
The individual responsible for the overall
conduct of a nonclinical laboratory study.
21 CFR Part 58.3(m)
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Definitions
Study Initiation Date
The date the protocol is signed by study director
Term defined in FDA, EPA FIFRA, EPA TSCA, OECD GLPs
Experimental Start Date Experimental Start Date
The first date the test substance is applied to
the test system.
Term defined in EPA FIFRA, EPA TSCA GLPs
Experimental Starting Date
The date on which the first study specific data
are collected.
Term defined in OECD GLPs
Definitions
Study Completion Date
The date the final report is signed by SD
Term defined in FDA, EPA FIFRA, EPA TSCA, OECD GLPs
Experimental Termination Date Experimental Termination Date
The last date on which data are collected
directly from the study
Term defined in EPA TSCA, EPA FIFRA GLPs
Experimental Completion Date
The last date on which data are collected from
the study
Term defined in OECD GLPs
GLPs are regulations that are intended
to ensure the quality and integrity of the to ensure the quality and integrity of the
data in a nonclinical laboratory study.
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GLPs are the LAW!
What are GLPs?
GLPs are regulations that are intended to ensure the quality
andintegrity of the data in a laboratory study
They are NOT ideas
They are NOT
governmental philosophy
They are NOT guidelines
and integrity of the data in a laboratory study.
Basic Information
GLPs deal with:
Planning
Performance
GLPs do NOT:
Attempt to
regulate science
E
Monitoring
Recording
Reporting
Ensure
good science
Basic Information
Responsibility for establishing the safety and efficacy of
human and veterinary drugs and devices, and the safety
of food and color additives is placed on the sponsor
(manufacturer) of the regulated product.
Public agencies (FDA, EPA, OECD, etc) are responsible
for reviewing the sponsors test results and determine if
they demonstrate the products safety and efficacy.
Only when the agencies are satisfied that safety and
efficacy have been established adequately is the
marketing of the product permitted.
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Nonclinical laboratory studies
GLP is needed for: GLP is not needed for:
Nonclinical safety studies of
development of drugs
Agric lt ral pesticide
Basic scientific research
Studies to develop new
anal tical methods (b t Agricultural pesticide
development
Development of toxic
chemicals
Food control (food
additives)
Test of substance with
regard to explosive hazards
analytical methods (but
Method Validation is GLP
required)
Chemical tests used to
derive the specifications of a
marketed food product
EPA
Environmental Protection Agency
(EPA)
Food and Drug Administration
(FDA)
United States
Federal Insecticide,
Fungicide and Rodenticide Act
(FIFRA)
Toxic Substance Control Act
(TSCA)
(EPA)
Federal Food, Drug and
Cosmetic Act
(FFDCA)
(FDA)
EPA FIFRA
Studies that support applications for research or
marketing permits for pesticide products regulated
by EPA
FDA
FDA FFDCA FDA FFDCA
Nonclinical laboratory studies that support
applications for research or marketing permits for
products regulated by FDA
Includes food and color additives, animal food
additives, human and animal drugs, medical devices
for humans, biological products and electronic
products
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International GLPs
Generally studies at will
are conducted under
GLPs from US, J apan,
etc and/or OECD etc. and/or OECD
Many protocols list all
three
Formal claims of
compliance with other
national regulations should
be avoided, if possible
Questions ?
Any questions?
IR-4 Project
Since 1963 IR-4 has been a US
government funded research program
USDA Interregional Research Project Number 4
government funded research program
to facilitate registration of sustainable
pest management technology for
specialty crops and minor uses
http://ir4.rutgers.edu
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The IR-4 Program - Partnerships
Specialty Crops
Most:
Vegetables
Fruits Fruits
Nuts
Herbs
Spices
Grower
i
Stakeholder Involvement
experiences
pest problem
Identify Pest
Management
Solution
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IR-4 Protocol
Every page contains
PR No.
Objectives
All Proposed Dates and Sites
Study Directors Signature, Date
Sponsor
Study Directors Initial
Study Directors Name
ASR Page
Testing Facility
Title of Study
PR Number
Testing Facility
Study Director
Sponsor
Study Initiation Date
Experimental Termination Date
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International Activities
Data-50 reports submitted to Canadas
J MPR/Reg. Authorities
Leadership-NAFTA, OECD, and Codex CCPR
C it B ildi /FAS i Af i A i C t l Capacity Building w/FAS in Africa, Asia, Central
and S. America
Global Residue Study
Global Minor Use Summit 2
Capacity Building
IR-4 Activities
Food Use Program
Bi d O i ti id Bio and Organic pesticides
Ornamental Program
Public Health
IR-4 Project Infrastructure - Pesticide Residue work
90 studies/550 field trials
IR-4 HQ
IR-4 Regional Program Office
State Satellite Labs
State Field Research Centers/Food Use
Hawaii = ARS Labs
ARS Field Research Centers
State Field Research Centers/ Ornamentals and
Non-food Use
ARS Field Research Centers
ARS Field Research Centers
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Thank
Y ! You!
jiangwa@msu.edu