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Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).
The material cost of a chemical process is the sum of the costs of all raw materials, intermediates, reagents, solvents, and catalysts procured from external vendors. Material costs may influence the selection of one synthetic route over another or the decision to outsource production of an intermediate.
Pharmaceutical manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry. The process of drug manufacturing can be broken down into a series of unit operations , such as milling , granulation , coating , tablet pressing , and others.
QA includes management of the quality of raw materials, assemblies, products and components, services related to production, and management, production and inspection processes. [8] The two principles also manifest before the background of developing (engineering) a novel technical product: The task of engineering is to make it work once, while ...
A raw material, also known as a feedstock, unprocessed material, or primary commodity, is a basic material that is used to produce goods, finished goods, energy, or intermediate materials that are feedstock for future finished products. As feedstock, the term connotes these materials are bottleneck assets and are required to produce other products.
A raw material going into a chemical process or plant as input to be converted into a product is commonly called a feedstock, or simply feed. In addition to feedstocks for the plant, as a whole, an input stream of material to be processed in a particular unit can similarly be considered feed for that unit.
A certified reference material is a particular form of measurement standard. Reference materials are particularly important for analytical chemistry and clinical analysis. [2] Since most analytical instrumentation is comparative, it requires a sample of known composition (reference material) for accurate calibration.
Life cycle assessment (LCA) is sometimes referred to synonymously as life cycle analysis in the scholarly and agency report literatures. [7] [1] [8] Also, due to the general nature of an LCA study of examining the life cycle impacts from raw material extraction (cradle) through disposal (grave), it is sometimes referred to as "cradle-to-grave analysis".