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Annex I of the Directive incorporates OECD Revised Guides for Compliance Monitoring Procedures for GLP, along with OECD Guidance for the Conduct of Test Facility Inspections and Study Audits. It ensures compliance with these guidelines during laboratory inspections and study audits. This directive replaced Directive 88/320/EEC as of 11 March 2004.
An assay (analysis) is never an isolated process, as it must be accompanied with pre- and post-analytic procedures. Both the communication order (the request to perform an assay plus related information) and the handling of the specimen itself (the collecting, documenting, transporting, and processing done before beginning the assay) are pre-analytic steps.
Validation of analytical procedures is imperative in demonstrating that a drug substance is suitable for a particular purpose. [5] Common validation characteristics include: accuracy, precision (repeatability and intermediate precision), specificity, detection limit, quantitation limit, linearity, range, and robustness.
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 .
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.
Procedures in analytical quality control, a type of verification and validation, designed to ensure that the results of laboratory analysis are consistent, comparable, accurate, and within specified limits of precision; Analytical procedures in magnetostratigraphy, a geophysical technique used for rock dating
Clinical laboratory in a hospital setting showing several automated analysers.. A medical laboratory or clinical laboratory is a laboratory where tests are conducted out on clinical specimens to obtain information about the health of a patient to aid in diagnosis, treatment, and prevention of disease. [1]
A laboratory (UK: / l ə ˈ b ɒr ə t ər i /; US: / ˈ l æ b r ə t ɔːr i /; colloquially lab) is a facility that provides controlled conditions in which scientific or technological research, experiments, and measurement may be performed. Laboratories are found in a variety of settings such as schools, universities, privately owned ...