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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).
More specifically, the ISPE's guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested ...
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.
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.
The pharmaceutical industry is currently facing increased pricing pressures globally and rising manufacturing costs. Cost of Goods (COGS) for Brand-Name pharmaceutical drugs can be higher than 30% of the total sales revenues of these companies. In comparison, the percentage of sales revenues spent on R&D by these pharmaceutical companies is ...
This material, exhibited at the 1862 London International Exhibition, anticipated many of the modern aesthetic and utility uses of plastics. The industrial production of soap from vegetable oils was started by William Lever and his brother James in 1885 in Lancashire based on a modern chemical process invented by William Hough Watson that used ...
Inside an iPhone . Material criticality is the determination of which materials that flow through an industry or economy are most important to the production process. It is a sub-category within the field of material flow analysis (MFA), which is a method to quantitatively analyze the flows of materials used for industrial production in an industry or economy.