Samenvatting
Summary lectures GLP
- Instelling
- Universiteit Antwerpen (UA)
Summary of the two lectures of GLP. Written in English.
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Voorbeeld 2 van de 15 pagina's
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Voorbeeld van de inhoud
GLP1. Explain the need for the GLP, why they were implemented and
how they are currently established and controlled in “non-clinical”
research laboratories.
2. Explain the organization and follow up of the GLPs at national
(Belgium) and international level.
3. What is GLP compliance and how this is evaluated.
Definition GLP
A QUALITY CONTROL SYSTEM covering the organisational process and
technical conditions under which NON-CLINICAL health and environmental studies
are planned, performed, monitored, recorded, reported and archived.
• They are mandatory to evaluate safety or toxicity of products that undergo
clinical trials
• Intended to ensure the quality and integrity of the results and data
generated
• They are seek to harmonise protocols, information and documentation of
standard operating procedures.
• They are established and promulgated by various organizations
o Organization for Economic Cooperation and Development (OECD)
o The Food and Drug Administration (FDA)
o The World Health Organization (WHO)
o Others.
GLP regulations do not apply to studies utilising:
• Human subjects or clinical studies.
• Basic exploratory studies to determine the potential utility of a test article
• FDA studies to study the physical or chemical characteristics of a test
article.
GLPs are mainly intended for:
• Non-clinical studies (animals or in vitro)
• To obtain data on the properties and/or safety of a test substance with
respect to human health and/or environment
• To guaranty the generation of quality data and assay reproducibility.
GLP promotes reliability and reproducibility of test data
GLP is intended to be submitted to a national registration authority
, Origin of GLP
GLP, or Good Laboratory Practice, originated in response to concerns about
unreliable and fraudulent safety testing in the 1960s and 1970s.
A major incident in the early 1970s, where labs falsified drug safety data, led the U.S.
FDA to set new research standards (GLP regulations) in 1978.
These regulations cover everything from the care and feeding of laboratory animals
to the storage and retrieval of raw statistics.
The OECD later established international GLP guidelines in 1981, which are
now widely adopted globally to standardize and improve laboratory practices.
The OECD assists countries in developing and implementing policies that make
their systems for managing chemicals as efficient and robust as possible while
protecting human health and the environment.
Products covered by OECD principles
-> They are applied to the non-clinical safety testing of test items in
pharmaceutical products, pesticide products, cosmetic products, veterinary drugs
as well as food additives, feed additives, and industrial chemicals.
Purpose of the GLP
principles
1. Ensure Data Quality:
Promote the generation of high-quality, accurate, reliable, and reproducible
data.
Ensures scientific validity and enhances the credibility of research studies.
2. Protect Human Health and the Environment:
Laboratories can identify potential risks and prevent harm to human
health and the environment.
3. International Harmonization:
Facilitate global harmonization of safety requirements, prevent test
duplication
4. Regulatory Compliance:
Increasing the likelihood of successful regulatory approvals.
5. Public Confidence
Examples of studies carried out under GLP
Physical-chemical testing
Toxicity studies
Mutagenicity studies
Environmental studies
Studies on the effects on ecosystems
Analytical and clinical chemistry testing
Studies to determine pesticide residues
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