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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.
In the pharmaceutical industry, a wide range of excipients may be blended together with the active pharmaceutical ingredient to create the final blend used to manufacture the solid dosage form. The range of materials that may be blended (excipients, API), presents a number of variables which must be addressed to achieve target product quality ...
In a laboratory setting, mixture of dissolved materials are typically fed using a solvent into a column packed with an appropriate adsorbent, and due to different affinities for solvent (moving phase) versus adsorbent (stationary phase) the components in the original mixture pass through the column in the moving phase at different rates, which ...
Material flow analysis (MFA), also referred to as substance flow analysis (SFA), is an analytical method to quantify flows and stocks of materials or substances in a well-defined system. MFA is an important tool to study the bio-physical aspects of human activity on different spatial and temporal scales.
Materials management is a core supply chain function and includes supply chain planning and supply chain execution capabilities. Specifically, materials management is the capability firms use to plan total material requirements. The material requirements are communicated to procurement and other functions for sourcing.
An assay (analysis) is never an isolated process, as it must be accompanied with pre- and post-analytic procedures. Both the communication order (the request to perform an assay plus related information) and the handling of the specimen itself (the collecting, documenting, transporting, and processing done before beginning the assay) are pre-analytic steps.
Chiral technology is an active subject matter related to asymmetric synthesis [18] and enantioselective analysis, particularly in the area of chiral chromatography. As a consequence of the advances in chiral technology, a number of pharmaceuticals currently marketed as racemic drugs are undergoing re-assessment as chiral specific products or ...