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A scientist at a research laboratory in Australia got infected with Dengue through a mosquito bite in the laboratory. [50] 2012 Anthrax United Kingdom The UK's Animal and Plant Health Agency sent out live samples of anthrax by mistake. Its Surrey lab was subject to a Crown Prohibition Notice (CPN), closing it until improvements were made. [51 ...
Manufacturing processes must be clearly defined and controlled. All critical processes are validated [8] to ensure consistency and compliance with specifications. Manufacturing processes must be controlled, and any changes to the process must be evaluated. Changes that affect the quality of the drug are validated [9] as necessary.
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
The recalls came in response to reports of renal failure in pets consuming mostly wet pet foods made with wheat gluten from a single Chinese company, beginning in February 2007. The recall began voluntarily with the Canadian company Menu Foods on March 16, 2007, when a company test showed sickness and death in some of the test animals. Overall ...
There are different definitions within laboratory quality control, wherein "analytical sensitivity" is defined as the smallest amount of substance in a sample that can accurately be measured by an assay (synonymously to detection limit), and "analytical specificity" is defined as the ability of an assay to measure one particular organism or ...
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FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
B89.7.3.1 - 2001 Guidelines for Decision Rules: Considering Measurement Uncertainty Determining Conformance to Specifications; B89.7.3.2 - 2007 Guidelines for the Evaluation of Dimensional Measurement Uncertainty (Technical Report) B89.7.3.3 - 2002 Guidelines for Assessing the Reliability of Dimensional Measurement Uncertainty Statements