What is GLP in pharma Slideshare?

What is GLP in pharma Slideshare?

GLP is a formal regulation that was created by the FDA (United states food and drug administration) in 1978. 3. Definition of GLP • GLP embodies a set of principles that provides a frame work within which laboratory studies are planned performed, monitored, and archived and reported.

What is GLP explain?

“Good Laboratory Practice”, or GLP for short, refers to a quality assurance system that is applied during the pre-clinical stage of research and development. Its aim is to test active ingredients under specific environmental conditions and over a defined period of time.

What is GLP PDF?

The definition of the term “Good. Laboratory Practice” itself, which identifies GLP as “a quality system related with the. organisational process and the conditions under which non-clinical health and. environmental safety studies are planned, performed, monitored, recorded, archived and. reported.”

What are the objectives of GLP?

Purpose of GLP to avoid duplication of research; to improve the protection of human health and environment; to facilitate international acceptance of test data; to prevent the creation of technical trade barriers.

What are the components of GLP?

Test facility organization and personnel.

  • Quality Assurance (QA) programme.
  • Facilities.
  • Test systems.
  • Performance of the study.
  • Reporting of study results.
  • Which tests are carried out under GLP?

    What types of tests are carried out at such facilities under GLP?

    • v) studies on behaviour in water, soil and air; bioaccumulation.
    • vi) studies to determine pesticide residues in food or animal feedstuffs.
    • vii) studies on effects on mesocosms and natural ecosystems; and.
    • viii) analytical and clinical chemistry testing.

    When was GLP introduced?

    GLP is an official regulation that was established in the United States in 1978, following an in-depth review of practices at toxicology laboratories.

    What are the elements of GLP?

    The components of Good Laboratory Practice are presented under the headings: type of laboratory work, discipline, management, personnel, premises, safety, equipment, reagents, standard operating procedures, internal quality control, external quality assessment, method, dedicated operating procedure, syllabi, and …

    What is GLP in pharma?

    In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products in development for human or animal health ( …

    What are elements of GLP?