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The Principles of Good Laboratory Practice (GLP) establish rules and criteria for a quality system that oversees the organizational processes and conditions in which non-clinical health and environmental safety studies are planned, conducted, monitored, recorded, reported, and archived.
CLSI provides direct assistance in Sub-Saharan Africa to combat HIV/AIDS and other infectious diseases. With grants from the US-based PEPFAR (President's Emergency Plan for AIDS Relief) program administered by a cooperative agreement from the Centers for Disease Control and Prevention (CDC) and the National Institute of Allergy and Infectious Diseases (NIAID), CLSI has been actively involved ...
WHO Good Clinical Laboratory Practice (GCLP) ISBN 978-92-4-159785-2; Stevens W. (2003) Good Clinical Laboratory Practice (GCLP): The need for a hybrid of Good Laboratory Practice and Good Clinical Practice guidelines/standards for medical testing laboratories conducting clinical trials in developing countries. Quality Assurance, 10: 83–89.
A LIMS covers standards such as 21 CFR Part 11 from the Food and Drug Administration (United States), ISO/IEC 17025, ISO 15189, ISO 20387, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), FDA Food Safety Modernization Act (FSMA), HACCP, and ISBER Best Practices.
Laboratory quality control is designed to detect, reduce, and correct deficiencies in a laboratory's internal analytical process prior to the release of patient results, in order to improve the quality of the results reported by the laboratory.
Clinical pathology is a medical specialty that is concerned with the diagnosis of disease based on the laboratory analysis of bodily fluids, such as blood, urine, and tissue homogenates or extracts using the tools of chemistry, microbiology, hematology, molecular pathology, and Immunohaematology. This specialty requires a medical residency.
Once a bacterium has been identified following microbiological culture, antibiotics are selected for susceptibility testing. [5] Susceptibility testing methods are based on exposing bacteria to antibiotics and observing the effect on the growth of the bacteria (phenotypic testing), or identifying specific genetic markers (genetic testing). [6]
The laboratory procedure involves making serial dilutions of the sample (1:10, 1:100, 1:1000, etc.) in sterile water and cultivating these on nutrient agar in a dish that is sealed and incubated. Typical media include plate count agar for a general count or MacConkey agar to count Gram-negative bacteria such as E. coli .