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Many laboratories contain significant risks, and the prevention of laboratory accidents requires great care and constant vigilance. [1] [2] Examples of risk factors include high voltages, high and low pressures and temperatures, corrosive and toxic chemicals and chemical vapours, radiation, fire, explosions, and biohazards including infective organisms and their toxins.
These principles exclude studies involving human subjects. Depending on the location or governing rules in an OECD-member country, the OECD Principles of GLP might also extend to non-clinical safety testing of other regulated items, like medical devices. [3] Examples studies conducted under GLP in OECD-member countries include:
Secondly, the laboratory supervisor, who reports to the laboratory director, is responsible for organizing regular training sessions on laboratory safety. [9] The third point, the personnel must be informed about any special hazards and be required to review the safety or operations manual and adhere to established practices and procedures. The ...
A laboratory-specific biosafety manual must be drafted which details how the laboratory will operate in compliance with all safety requirements. [ 21 ] All laboratory personnel are provided medical surveillance and offered relevant immunizations (where available) to reduce the risk of an accidental or unnoticed infection.
The Westgard rules are a set of statistical patterns, each being unlikely to occur by random variability, thereby raising a suspicion of faulty accuracy or precision of the measurement system. They are used for laboratory quality control , in "runs" consisting of measurements of multiple samples.
All analytical procedures should be validated. Identification tests are conducted to ensure the identity of an analyte in a sample through comparison of the sample to a reference standard through methods such as spectrum, chromatographic behavior, and chemical reactivity. [5] Impurity testing can either be a quantitative test or a limit test.
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Westgard rules are commonly used to analyse data in Shewhart control charts. Westgard rules are used to define specific performance limits for a particular assay (test) and can be used to detect both random and systematic errors. Westgard rules are programmed into automated analyzers to determine when an analytical run should be rejected. These ...