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Pharmacoeconomics refers to the scientific discipline that compares the value of one pharmaceutical drug or drug therapy to another. [ 1 ] [ 2 ] It is a sub-discipline of health economics . A pharmacoeconomic study evaluates the cost (expressed in monetary terms) and effects (expressed in terms of monetary value, efficacy or enhanced quality of ...
It is the company's responsibility to determine the most effective and efficient quality process that both meets business and regulatory needs. [1]: "Decision Makers' Summary", [2] Regulatory agencies have recently begun to look at more fundamental quality metrics of manufacturers than just compliance with basic GMP regulations.
The quality service level (QSL) is a measure of the reproducibility of the quality of the isolated intermediate or final API. While the details of computing this value are slightly nuanced and unimportant for the purposes of this article, in essence, the calculation involves the ratio of satisfactory quality batches to the total number of batches.
Quality Control is the ongoing effort to maintain the integrity of a process to maintain the reliability of achieving an outcome. Quality Assurance is the planned or systematic actions necessary to provide enough confidence that a product or service will satisfy the given requirements.
Statistical process control (SPC) or statistical quality control (SQC) is the application of statistical methods to monitor and control the quality of a production process. This helps to ensure that the process operates efficiently, producing more specification-conforming products with less waste scrap.
Control charts are graphical plots used in production control to determine whether quality and manufacturing processes are being controlled under stable conditions. (ISO 7870-1) [1] The hourly status is arranged on the graph, and the occurrence of abnormalities is judged based on the presence of data that differs from the conventional trend or deviates from the control limit line.
Cost-effectiveness analysis (CEA) is a form of economic analysis that compares the relative costs and outcomes (effects) of different courses of action. Cost-effectiveness analysis is distinct from cost–benefit analysis, which assigns a monetary value to the measure of effect. [1]
A Master of Science in Quality Management and Analytics (abbreviated QMA or MSQMA) is a postgraduate academic master's degree in Quality Management and Analytics, also known as M.S. in QM and Analytics. Candidates of M.S. in Quality Management and Analytics are required to have at least a bachelor's degree from an accredited university.