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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).
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.
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.
This is a list of analysis methods used in materials science. Analysis methods are listed by their acronym, if one exists. Analysis methods are listed by their acronym, if one exists. Contents:
The ASME BPE is a voluntary consensus standard written by a team of over three hundred balanced subject matter experts. These individuals provide their knowledge and experience to drive technology and innovation forward safely and responsibly for the manufacturing of modern biopharmaceuticals.
The first instrumental analysis was flame emissive spectrometry developed by Robert Bunsen and Gustav Kirchhoff who discovered rubidium (Rb) and caesium (Cs) in 1860. [4] Most of the major developments in analytical chemistry took place after 1900. During this period, instrumental analysis became progressively dominant in the field.
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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.