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Good Laboratory Practices

GLP regulations aim to ensure the quality and validity of safety studies by requiring standardized practices in study planning, conduct, recording, reporting, and archiving. Key aspects include requiring detailed study protocols and SOPs, maintaining accurate raw data, comprehensive reporting, and independent quality assurance oversight. GLP applies internationally to nonclinical studies intended to support product applications.

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Gerald Limo Arap Chebii
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115 views24 pages

Good Laboratory Practices

GLP regulations aim to ensure the quality and validity of safety studies by requiring standardized practices in study planning, conduct, recording, reporting, and archiving. Key aspects include requiring detailed study protocols and SOPs, maintaining accurate raw data, comprehensive reporting, and independent quality assurance oversight. GLP applies internationally to nonclinical studies intended to support product applications.

Uploaded by

Gerald Limo Arap Chebii
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PPT, PDF, TXT or read online on Scribd
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GOOD LABORATORY

PRACTICES
Introduction
• GLP is a regulation covering the quality management of non-clinical safety
studies.

• The aim of the regulation is to encourage scientists to organize and perform


their studies in a way which promotes the quality and validity of the test data.

• Good Laboratory Practices (GLP) apply when a non-clinical laboratory study


(e.g. Pre-Clinical animal testing) is intended to support an application for an
FDA-regulated product.
History
• In the early 1970s, the FDA investigated a number of cases of poor practice in
toxicology laboratories throughout the USA

• Results of this investigation in about 40 laboratories revealed many cases of


poorly managed studies, insufficient training of personnel and some cases of
deliberate fraud
History:FDA investigation findings
History (Cont’d)
• The results of these investigations revealed a situation that could only be dealt
with by imposing binding (GLP) regulations.

• GLP regulations were first instituted by US FDA, then by US Environmental


Protection Agency (EPA)

• Many other nations have since followed suit.


Aims of GLP
• The intent of GLP is to:
• Regulate the practices of scientists working on the safety testing of
prospective drugs
• Ensure that scientists do not invent or manipulate safety data
• Ensure that studies are properly managed and conducted, thereby
considerably increasing the chances of producing valid experimental data.
• Guarantee that safety data are being honestly reported to the registration
authorities.
• The results of these studies form the basis for the decision to proceed with
clinical trials, prior to allowing a new drug onto the market.
Reasons for GLP in the organization of safety
studies.
• Limiting waste of resources: This is particularly aimed at limiting the use
of animals.
• Ensuring high quality results : This is concerned with the validity of test
data.
• Ensuring comparability: Means that better information can be obtained in
order to allow registration authorities to decide between candidate
medicines.
• Mutual recognition of results: Refers to the fact that GLP is an
internationally accepted set of regulations for the conduct of studies.
The fundamentals of GLP
• The GLP regulations set out the rules for good practice and help researchers
perform their work in compliance with their own pre-established plans and
standardized procedures.

• GLP stipulates the conditions for the organization of studies

• The regulations are not concerned with the scientific or technical content of
the research programmes.

• As such, GLP is a quality system for the management of non-clinical studies.


Scope of GLP
GLP defines the working environment under which studies are:
•PLANNED: Great emphasis is placed on the study plan (protocol) and to planned changes
throughout the study.
•PERFORMED: This refers to the standard operating procedures (SOPs) which are a GLP
requirement.
•RECORDED: i.e. the collection of raw data and the recording of deviations, if any, during the
study.
•REPORTED: one of the problems pre-GLP was that study reports did not always reflect the
study data accurately. Assuring accuracy in the report has now become an essential part of
GLP.
•ARCHIVED: As studies may be audited many years after their completion, it is important that
the study data, specimens, samples and reports are properly archived.
•MONITORED: Monitoring by study staff, quality assurance personnel and national inspectors
helps to assure GLP compliance.
Scope of GLP(cont’d)
GLP covers the following areas:
•Resources: Personnel, facilities and equipment

•Study plans (protocols) and written standard operating procedures

•Results: raw data, final report and archives

•Quality Assurance.
1. Resources: Personnel
• GLP regulations require that the qualifications and the training of staff must be defined
and documented.

• GLP also stresses that there should be sufficient staff to perform the tasks required.

• Each individual engaged in the conduct of or responsible for the supervision of a


nonclinical laboratory study shall have education, training, and experience, or
combination thereof, to enable that individual to perform the assigned functions.

• GLP requires that 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.
Personnel: Study director
• For each nonclinical laboratory study, a scientist or other professional of
appropriate education, training, and experience, or combination thereof, shall
be identified as the study director.

• The study director has overall responsibility for the technical conduct of the
study, as well as for the interpretation, analysis, documentation, and reporting
of results, and represents the single point of study control.
Resources: Facilities and equipment
• The regulations emphasize the need for sufficient facilities and
equipment to perform the studies.

• All equipment must be in working order.

• To ensure this, a strict programme of calibration and maintenance


must be adopted.
Resources: Facilities and equipment
• Each testing facility shall be of appropriate design and capacity to facilitate the
proper conduct of nonclinical laboratory studies.

• It shall be designed so that there is a degree of separation that will prevent


any function or activity from having an adverse effect on the study.

• The design should include:


• Animal care facilities
• Facilities for handling test and control articles
• Laboratory operation areas
• Specimen and data storage facilities
Equipment: Maintenance & Calibration
• Equipment shall be adequately inspected, cleaned & maintained

• Equipment used for assessment of data shall be tested, calibrated


and/or standardized

• Scales & balances should be calibrated at regular intervals (usually


ranging from 1-12 months)
2. Protocols and written procedures
• The main steps of research studies are prescribed in the study plan or protocol.

• However, the protocol, which provides the experimental design and timeframe
for the study, does not contain all the technical detail necessary to conduct the
study.

• These details are found in written standard operating procedures (SOPs).

• With the protocol and the SOPs it should be possible to repeat the study
exactly, if necessary.
SOPs:Animal Care
• SOPs are required for all aspects of animal care

• Newly received animals shall be isolated & health status


evaluated

• Animals shall be free of any disease or condition that might


interfere at beginning of study
SOPs: Animal Care (cont’d)
• Animals of different species shall be housed in separate
rooms

• Feed & water should be analyzed periodically for


contaminants
Standard Operating Procedures
(SOPs)
• Testing facility shall have SOPs adequate to insure the quality &
integrity of the data generated in the course of a study

• All deviations from SOPs shall be authorized by the study director &
documented in the raw data
3. Results: Raw data
• All studies generate raw data.

• These are the outcome of research and form the basis for establishing
scientific interpretations and arriving at conclusions.

• The raw data must also reflect the procedures and conditions of the
study.
Results: The study report

•This contains an account of the way in which the study was performed,

•It incorporates the study results and includes the scientific interpretation of
the data.

•The report is provided to regulatory authorities as part of the submission for


registration and marketing approval.
Results: Archives

• Storage of records must ensure safekeeping for many years and allow
for prompt retrieval.
4. Quality Assurance
• Quality assurance (QA), as defined by GLP, is a team of persons (often called
the Quality assurance unit – QAU) charged with assuring management that the
facilities, equipment, personnel, methods, practices, records, and controls are
in conformance with the GLP regulations.

• QA must be independent from scientists involved in the direction and conduct


of that study.

• QA functions as a witness to the whole non-clinical research process.


Quality Assurance Unit (QAU)
• QAU:
• Maintains a copy of master schedule sheet of all nonclinical laboratory studies

• Inspects each study at intervals adequate to assure the integrity of the study

• Determines that no deviations from approved protocols or SOPs were made


without proper authorization & documentation

• Review the final study report to assure methods & SOPs reflect raw data

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