Quality Risk Management: A systematic process for the assessment, control, communication and review of risks to the quality of the drug products across the product lifecycle (ICH Q9). Quality Target Product Profile (QTPP); A prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, safety and efficacy of the drug product. Reference Listed Drug (RLD), RLD is an approved drug product to which new generic versions are compared to show that they are bioequivalent. Rheology: is the study of the flow of matter, primarily in a liquid state. It describes the interrelation between force, deformation and time. Robustness: refer to the ability of an analytical method to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage. State of Control: A condition in which the set of controls consistently provides assurance of continued process p...
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