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Good Laboratory Practices&
Good Clinical Practices
Presented by:-
Mr. Swapnil L. PatilM.Pharm (Semester-2)Department of Pharmaceutics
Pad. Dr. D. Y. Patil College of Pharmacy,
Akurdi, Pune, Maharashtra, India, 411018.
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Good Laboratory Practices
.
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Contents:
Introduction
HistoryObjective
Rules and regulation
Noncompliance
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GLP: GOOD LABORATORY
PRACTICE GLP is an FDA regulation.
Definition: GLP embodies a
set of principles thatprovides a framework withinwhich laboratory studies are
planned , performed,monitored, recorded,reported and archived.
GLP is sometimes confusedwith the standards oflaboratory safety likewearing safety goggles.
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GOOD LABORATORY
PRACTICE
GLP applies to nonclinical studies
conducted for the assessment of the safety
or efficacyof chemicals (including
pharmaceuticals).
GLP helps assure regulatory authorities that
the data submitted are a true.5
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HISTORY
The formal regulatory conceptof Good
Laboratory Practice (GLP) originated in the
USA in the 1970s.
The FDAs publication of Proposed Regulations on
GLP in 1976, with establishment of the Final Rule in
June 1979 (21 CFR 58).
In 1981an organization named OECD produced
GLP principles that are international standard.6
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WHY WAS GLP CREATED?In the early 70s FDA became aware
of cases of ( PLP )poor laboratorypractice all over the United States.
FDA decided to do an in-depthinvestigation in 40 toxicology labs.
They discovered a lot fraudulent
activities and a lot of poor labpractices.
Examplesof some of these ( PLP )poor lab practices found were
Equipment not been calibrated to
standard form , therefore givingwrong measurements.
Incorrect/inaccurate accounts of theactual lab study
Inadequate plan
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FAMOUS EXAMPLE
One of the labs that went undersuch an investigation madeheadline news.
The name of the Lab wasIndustrial Bio Test. This was abig lab that ran tests for bigcompanies such as Procter andGamble.
It was discovered that mice thatthey had used to test lotion anddeodorants had developed cancerand died
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Industrial Bio Test lab threw the dead mice and coveredresults deeming the products good for human use.
Those involved in production, distribution and sales for
the IBT lab eventually served jail time.
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OBJECTIVES OF GLP
GLP makes sure that the data submitted are a
true reflectionof the results that are obtained
during the study. GLP also makes sure that data is traceable.
Promotes international acceptance of tests.
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MISSION OF GLP
Test systems
Archiving of records .Apparatus, material and reagent facilities.
Quality assurance programs.
Performance of the study.Reporting of study results.
Standard operating procedures (SOP)
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21 CFR Part 58: Non-Clinical
Laboratory Studies
Subpart A: General Provisions
Subpart B: Organization and Personnel
Subpart C: Facilities
Subpart D: Equipment
Subpart E: Testing Facilities Operation
Subpart F: Test and Control ArticlesSubpart G: Protocol for and Conduct of a Non-Clinical
Laboratory Study
Subpart J: Records and Reports
Subpart K: Disqualification of Testing Facilities 12
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GLP Regulations: Rules and Tools
Chemical and sample inventory,
expiration dates
TEST, CONTROL, AND
REFERENCE SUBSTANCES
Timely reporting, storage of raw
data and reports
RECORDS AND REPORTS
Standard operating proceduresFACILITY OPERATION
Calibration, logbooks of use, repair,
and maintenance
EQUIPMENT
Maintain adequate space/separationof chemicals from office areasFACILITIES
Training records, CVs, GLP trainingORGANIZATION AND
PERSONNEL
Documentation (Tools)GLP Regulations (Rules)
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Organization and Personnel
58.29 Personnel
(a)Each individual engaged in the conduct of or responsible
for the supervision of a nonclinical laboratory study shallhave education, training, and experience, or combination
thereof, to enable that individual to perform the assigned
functions.
(b)Each testing facility shall maintain a current summary of
training and experience and job description for each
individual engaged in or supervising the conduct of a
nonclinical laboratory study.14
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Organization and Personnel
58.33 Study Director
For each nonclinical laboratory
study, a scientist or other
professional of appropriate
education, training, andexperience, or combination
thereof, shall be identified as the
study director. The study director
has overall responsibility for the
technical conduct of the study,aswell as for the interpretation,
analysis, documentation, and
reporting of results, and represents
the single point of study control.
58.35 Quality Assurance
Unit
A testing facility shall have a
quality assurance unit which shall
be responsible for monitoring
each study to assure management
that the facilities, equipment,
personnel, methods, practices,
records, and controls are in
conformance with the regulations
in this part. For any given study,the quality assurance unit shall be
entirely separate from and
independent of the personnel
engaged in the direction and
conduct of that study. 15
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Facilities58.41 General
Each testing facility shall be of suitable size andconstructionto facilitate the proper conduct ofnonclinical laboratory studies. It shall be designed sothat there is a degree of separation that will prevent anyfunction or activity from having an adverse effect on thestudy.
Animal care facilities
Animal supply facilities
Facilities for handling test and control articles
Laboratory operation areas
Specimen and data storage facilities 16
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Equipment
58.61 Equipment Design
Equipment used in ... shall be of appropriate design and adequate capacity...
58.63 Maintenance and Calibration
(a) The written standard operating procedures ...
(b) Written records shall be maintained ...
Log book
Fit for use
Not for
GLPuse.
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Equipment Verification (Testing):
external check of
equipment accuracy (e.g.
check balance accuracy
against weights atlaboratory- no adjustment)
Calibration:equipment is
adjusted based on
comparison to certified or
known reference materials(e.g. balance adjusted after
comparison to certified
weights by trained
professional)
Standardization:
comparison with similar
equipment (e.g. use two
thermometers of similar
design to compare
readings)
Verification??
Calibration ? Standardization?
??
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Protocol , Reports and Records
58.120 Protocol
Each study shall have an approved written protocol that clearly indicates theobjectives and all methods for the conduct of the study.
58.130 Conduct of a Non-clinical Laboratory Study
The nonclinical laboratory study shall be conducted in accordance with theprotocol
58.185 Reporting of Non-clinical Laboratory Study Results
A final report shall be prepared for each nonclinical laboratory study ...
58.190 Storage and Retrieval of Records and Data
All raw data, documentation, protocols, final reports, and specimens ... shallbe retained.
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Raw Data
Definitions. Raw datameansany laboratory worksheets, records,
memoranda, notes, or exact copiesthereof, that are the result of originalobservations and activities of a study andare necessary for the reconstruction andevaluation of the report of that study.
If anyone scribble some notes on a scrap of paper,are those notes considered raw data?
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Raw Dataexamples of raw
data:-
Logbooks(to recordtemperatures or
equipment use, repair,
and maintenance) Field or laboratory
notebooks
Forms(for field orlaboratory
observations, chain-of-custody, sample or
chemical receipt)
Training reports
Computer printouts
Recorded data fromautomated instruments
Question:
What happens if youmake a mistake?
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40 CFR Part 160 (EPA GLP regulations)
Section 160.81 Standard operating procedures. (a) A testing
facility shall have standard operating procedures in writing
setting forth study methods that management is satisfied areadequate to insure the quality and integrity of the data
generated in the course of a study.
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
Standard Operating Procedures (SOP)
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Standard Operating Procedures
(SOP)SOPs shouldaccurately reflecthow routine tasksare performed
Routine inspection,cleaning, maintenance,testing and calibration.
Actions to be taken in
response to equipmentfailure.
Reviewed on regularbasis.
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What happens if a workplace does
not comply with federal GoodLaboratory Practice standards?
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Possible Violations
Falsifying information forpermit, registration
or any required records
Falsifying information related to testing~protocols, ingredients, observations, data
equipment, ect.
Failure to prepare, retain, or submit writtenrecords required by law.
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Consequences of Noncompliance
The FDA states the following consequences ofnoncompliance:
The commissioner will send a written proposalof
disqualification to the testing facility
A regulatory hearing on the disqualification will bescheduled
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 studyitself, or did
not occur at all, then the study may be reinstated at the will
of the commissioner
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Upon Disqualification
If the commissioner finds that the facility showed anoncompliance, any of the grounds after the hearing, then a
final order of noncompliance will be sent to the facility
with explanations
If a testing facility has been disqualified, any studies donebefore of after the disqualification will need to be determinedas essential to a decision (acceptable or not)
If the study is determined unacceptable, then the facility itselfmay need to show that the study was not affected by thenoncompliance that led to the disqualification
Once finally disqualified, the facility may not receive or be
considered for a research or marketing permit and the study isrejected.
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Upon Disqualification The commissioner may notify the public and all interested
persons, including other federal agencies the facility may havecontacted
The FDA may ask the other agencies to consider whether tosupport the facility or not under the disqualification
Civil or criminal proceedings may occur at the discretion ofthe commissioner Fines of up to $50,000 if one knowingly commits crime
and/or 1 year imprisonment~ for registration applicants andproducers
Fines up to $5,000 all others~ civil penalty after failing toimprove after a minor violation warning was issued~ onlythose involved in testing will be given civil penalties
Those involved in the distribution or sales will be assessedmore heavy penalties, such as criminal penalties
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Upon Disqualification
The FDA may turn it over to the federal, state or locallaw enforcement
The facilitys sponsor may terminate or suspend thefacility 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 besuspended or terminated and why
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Reinstatement of a Disqualified
Facility
The commissioner will inspect the facility and
determine if it shall be reinstated If it is reinstated, the commissioner is required
to notify all persons that were notified of the
disqualification including the facility itself
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Good Clinical Practice
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Contents
Glossary
Principles of GCP
IEC/IRB Responsibilities Investigator Responsibilities
Sponsor Responsibilities
Protocols and Amendments
Investigators Brochure
Essential Documents32
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Glossary
Adverse drug reaction (ADR)
Serious Adverse Event (SAE)
Audit
Blinding/masking
Investigator
Protocol
Sponsor
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History of Good Clinical Practice Prior to an actual set of guidelines to follow for good clinical
practice, clinical studies were dangerous and could result in
serous disease, or possibly death.
The Nuremburg Code of 1947 Experiments performed in Germany during WWII opened the eyes of
the world for guidance for clinical testing on humans.
The code did set ethical guidelines, but it lacked legislation to back it
up.
Declaration of Helsinki
In 1964, the World Medical Association established
recommendations guiding medical doctors in biomedical research
involving human subjects. These guidelines influenced national
legislation, but there was no set standard between nations.34
GOOD CLINICAL
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GOOD CLINICAL
PRACTICE
FDA ICH
21 CFR InternationalElectronic Docs.
Inf. Consent
Financial Disclosure
IRBs
IND regs.
glossary
principles
IRBs
Investigator
SponsorEssential Docs
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ICH Guidelines ICH Guidelines are divided into 4 main topics:
Quality Topicsrelate to chemical and pharmaceutical quality
assurance
e.g. Q1 Stability Testing
Safety Topicsrelate to preclinical studies
e.g. S1 Carcinogenicity Testing
Multidisciplinary Topicscross-cutting topics
which dont fit into one of the other categoriese.g. M1 Medical Terminology
Efficacy Topicsrelate to clinical studies in human subjects
e.g. E6 Good Clinical Practice;
e.g. E2A Clinical Safety Data Management:
e.g. E9 Statistical Principles for Clinical Trials 36
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FDA Regulations
21 C.F.R. Part 312, Subpart D (Duties of
Sponsors, Investigators)
21 C.F.R. Part 50 (Informed Consent)21 C.F.R. Part 56 (Institutional Review
Boards)
21 C.F.R. Part 54 (Investigator Financial
Disclosure)
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What is
Good Clinical Practice (GCP) is defined as a
standard for the design, conduct,
performance, monitoring, auditing,recording, analyses and reportingof clinical
trials that provides assurance that the data
and reported results are credible andaccurate, and that the rights, integrity and
confidentiality of trial subjects are
protected38
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Good Clinical Practice (GCP) is aninternational ethical and scientific quality
standard for designing, conducting,recording, and reporting trials that involvethe participation of human patients.
Compliance with this standard providespublic assurance that the rights, safety andwell-being of trial patients are protected and
clinical trial data are credible. 39
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Are mainly focused on the protection of human rightsin clinical trial.
Provide assurance of the safety of the newly
developed compounds. Provide standards on how clinical trials should be
conducted. Define the roles and responsibilities of - Clinical Sponsors, Clinical Research Investigators, Clinical Research Associates, And Monitors.
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Principles of ICH GCP
1. Clinical trials should be conducted in accordance with the ethical
principles that have their origin in the Declaration of Helsinki, and
that are consistent with GCP and the applicable regulatory
requirements.
2. Before a trial is initiated, foreseeable
risks and inconveniences should be
weighed against the anticipated benefitfor the individual trial subject & society.
A trial should be initiated and continued only if the anticipated
benefits justify the risks.
Benefits RISKS
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Principles of ICH GCP Continued
3. The rights, safety, and well-being of the trial subjects arethe most important considerations and should prevailover interests of science & society.
4. The available non-clinical & clinical information on aninvestigational product should be adequate to support the
proposed clinical trial.
5. Clinical trials should be scientifically sound, anddescribe in a clear, detailed protocol.
6. A trial should be conducted in compliance with the
protocol that has received prior IRB (or IEC) approval. 42
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Principles of ICH GCP Continued
7. The medical care given to, and medical decisions made
on behalf of, subjects should always be the responsibility
of a qualified physician or, when appropriate, of a
qualified dentist.
8. Each individual involved in conducting a trial should be
qualified by education, training and experience to
perform his or her respective tasks.
9. Freely given informed consent should be obtained from
every subject prior to clinical trial participation.43
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Principles of ICH GCP Continued
10. All clinical trial information should be recorded, handled,
and stored in a way that allows its accurate reporting,
interpretation, and verification.
11. The confidentiality of records that
could identify subjects should be
protected, respecting the privacy
and confidentiality rules in accordance
with the applicable regulatory
compliance.
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Principles of ICH GCP Continued
12. Investigational products should be manufactured, handled,
and stored in accordance with applicable good
manufacturing practice (GMP). They should be used inaccordance with the approved protocol
13.Systems with procedures that assure the quality of every
aspects of the trial should be implemented.
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Institutional Review Board (IRB),
Independent Ethics Committee (IEC)
A formally designated group that oversees research
involving human subjects.
Approves and disapproves human subject research.
According to the standards of the community or theinstitution, the IRB/IEC may require modifications to a
protocol to ensure patient safety.
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IRB Function
The primary function of an IRB/IEC is to safe guard the
rights ,safety ,and well being of all trial subjects. This isaccomplished by initial, continuing and annual review.
An IRB should consist of members who collectively have
the qualifications and experience to review and evaluatethe science , medical aspects, and ethics of the proposed
trial.
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IRB Members
1.A minimum of five (5) members.
2.One member whose concern is not scientific.
3.One member who has no personal or familial
relationship to the institution or trial site.
4.Any member with a conflict of interest may not
participate in any part of the review or vote (except to
provide requested information).
5.Individuals with special expertise may be invited to assist
with areas of unique or complex nature. These will not be
voting members.
6.A list of IRB/IEC members and their qualifications
should be maintained.48
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IRB/Ethics Committee
All studies must be approved prior to recruiting
participants
IRB must review all documents given to participants
Reporting AEs and Deviations from protocol to the IRB
Maintenance of Records
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Investigator Responsibilities
Adequate Resources
Recruitment
TimeQualified Staff
Facilities
Training
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Investigator Responsibilities
Medical Care
A qualified MD (or dentist) responsible for
trial-related medical decisionsProvide adequate medical care for AEs or other
significant medical condition
Inform PCP about participation in trial
Make a reasonable effort to ascertain why
participant withdrawals from study
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Investigator Responsibilities
Compliance with Protocol
Investigator should sign off on protocol
Investigator should not implement deviationsfrom protocol
If deviations occur, they should be documented
and reported at once to the sponsor, the IRB
and other regulatory authorities
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Investigator Responsibilities
Progress Reports
Written summary of trial
status to the IRB
Written reports to thesponsor or regulatory
authority of any changes
affecting the trial
Safety Monitoring
SAEs should be reported
immediately
AEs should be reportedaccording to sponsor
guidelines
Supply sponsor & IRB
with requested materialson participant deaths
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Investigator Responsibilities
Premature Termination
or Suspension
Promptly inform trial
subjectsAssure appropriate
therapy & follow-up
Inform sponsor,
regulatory authorities &IRB
Final Reporting
Inform IRB of study
completion & a summary
of the trials outcomeProvide sponsor &
regulatory authorities
with all required reports
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Investigators Brochure
Defined as a compilation of the
clinical and nonclinical data on
the investigational product(s)
that are relevant to the study of
the product(s) in human
subjects.
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Clinical Trial Protocol
General Information
Background Information
Trial Objectives & PurposeTrial Design
Selection & Withdrawal of Participants
Treatment of SubjectsAssessment of Efficacy
Assessment of Safety56
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Sponsor Responsibilities
Quality Assurance & Quality Control
Provide written SOPs
Secures agreement between all partiesData handling
Contract Research Organization (CRO)
Hired by the sponsor to implement trial-related duties
Medical Expertise
Designated medical personnel to advise on trial-related
medical questions and problems
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Sponsor Responsibilities
Trial DesignDesigns CRFs
Planning analyses
Trial Management, Data Handling,Recordkeeping, & Independent Data MonitoringCommittee (DMC)
Qualified personnel to supervise overall conduct of the
study
DMC assesses the progress of the clinical trial
Maintain SOPs for electronic data processing
Inform Investigator of guidelines for record retention58
E ti l D t f th C d t f
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Essential Documents for the Conduct of a
Clinical Trial
Preclinical trial
commencement
During clinical conduct
of trial
After completion or
termination of trial59
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Storage of Essential Documents
Sponsor Rule: refer to studyprotocol
FDA Rule: 2 options
2 years following marketing ofthe drug or,
2 years after IND applicationis withdrawn if drug was notmarketed
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References
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References
http://www.fda.gov/oc/gcp/guidance.htm
http://www.clinicaltrials.gov/
http://www.fda.gov/oc/ohrt/irbs/websites.htmlhttp://ohrp.osophs.dhhs.gov/
http://privacyruleandresearch.nih.gov/
http://en.wikipedia.org/wiki/ICH-GCPHandbook: good laboratory practice (GLP): quality
practices for regulated non-clinical research and
development -2nd ed., WHO Library Cataloguing-in-
Publication Data, 2nd ed., 7,15-20.62
http://www.fda.gov/oc/gcp/guidance.htmhttp://www.clinicaltrials.gov/http://www.fda.gov/oc/ohrt/irbs/websites.htmlhttp://ohrp.osophs.dhhs.gov/http://privacyruleandresearch.nih.gov/http://en.wikipedia.org/wiki/ICH-GCPhttp://en.wikipedia.org/wiki/ICH-GCPhttp://en.wikipedia.org/wiki/ICH-GCPhttp://en.wikipedia.org/wiki/ICH-GCPhttp://privacyruleandresearch.nih.gov/http://ohrp.osophs.dhhs.gov/http://www.fda.gov/oc/ohrt/irbs/websites.htmlhttp://www.clinicaltrials.gov/http://www.fda.gov/oc/gcp/guidance.htmhttp://www.fda.gov/oc/gcp/guidance.htm8/11/2019 GLP AND GCP
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References
OECD Principles of Good Laboratory Practice (as
revised in 1997)". OECD Environmental Health
and Safety Publications(OECD) 1. 1998.http://www.oecd.org/document/63/0,2340,en_264
9_34381_2346175_1_1_1_37465,00.html.
Schneider, K (1983(Spring)). "Faking it: The case
against Industrial Bio-Test Laboratories".AmicusJournal(Natural Resources Defence Council): 14-
26. http://planetwaves.net/contents/faking_it.html.
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http://www.oecd.org/document/63/0,2340,en_2649_34381_2346175_1_1_1_37465,00.htmlhttp://www.oecd.org/document/63/0,2340,en_2649_34381_2346175_1_1_1_37465,00.htmlhttp://en.wikipedia.org/wiki/OECDhttp://www.oecd.org/document/63/0,2340,en_2649_34381_2346175_1_1_1_37465,00.htmlhttp://www.oecd.org/document/63/0,2340,en_2649_34381_2346175_1_1_1_37465,00.htmlhttp://planetwaves.net/contents/faking_it.htmlhttp://planetwaves.net/contents/faking_it.htmlhttp://planetwaves.net/contents/faking_it.htmlhttp://planetwaves.net/contents/faking_it.htmlhttp://planetwaves.net/contents/faking_it.htmlhttp://planetwaves.net/contents/faking_it.htmlhttp://planetwaves.net/contents/faking_it.htmlhttp://planetwaves.net/contents/faking_it.htmlhttp://www.oecd.org/document/63/0,2340,en_2649_34381_2346175_1_1_1_37465,00.htmlhttp://www.oecd.org/document/63/0,2340,en_2649_34381_2346175_1_1_1_37465,00.htmlhttp://en.wikipedia.org/wiki/OECDhttp://www.oecd.org/document/63/0,2340,en_2649_34381_2346175_1_1_1_37465,00.htmlhttp://www.oecd.org/document/63/0,2340,en_2649_34381_2346175_1_1_1_37465,00.html8/11/2019 GLP AND GCP
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References
Tweedale, AC (2011). "Uses of Good Laboratory
Practices by regulated industry and agencies, and
the safety of bisphenol A".J Epidemiol
Community Health(BMJ Group) Online First: 15
February 2011. doi:10.1136/jech.2010.127761.
Webster, Gregory K. et al.(2005). "JALA
Tutorial: Considerations When ImplementingAutomated Methods into GcP".Journal of the
Association for Laboratory Automation(Elsevier)
10(3): 182191. doi:10.1016/j.jala.2005.03.00364
http://en.wikipedia.org/wiki/Digital_object_identifierhttp://dx.doi.org/10.1136/jech.2010.127761http://en.wikipedia.org/wiki/Elsevierhttp://en.wikipedia.org/wiki/Digital_object_identifierhttp://dx.doi.org/10.1016/j.jala.2005.03.003http://dx.doi.org/10.1016/j.jala.2005.03.003http://en.wikipedia.org/wiki/Digital_object_identifierhttp://en.wikipedia.org/wiki/Elsevierhttp://dx.doi.org/10.1136/jech.2010.127761http://en.wikipedia.org/wiki/Digital_object_identifier8/11/2019 GLP AND GCP
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.
Question????
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hank you.
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