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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.
Process manufacturing is a branch of manufacturing that is associated with formulas and manufacturing recipes, [1] and can be contrasted with discrete manufacturing, which is concerned with discrete units, bills of materials and the assembly of components. Process manufacturing is also referred to as a 'process industry' which is defined as an ...
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.
DGDA regulates all activities related to import and export of raw materials, packaging materials, production, sale, pricing, licensing, registration of all kinds of medicine including those of Ayurvedic, Unani, herbal and homeopathic systems. [2] The Pharmacy Council of Bangladesh(PCB) was established under the Pharmacy Ordinance Act in 1976.
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 ...
Crude drugs are unrefined natural medications in their raw forms. Prior to the 1950s, every pharmacy student learned about crude drugs in pharmacognosy class. Pharmacognosy is the study of the proper horticulture , harvesting and uses of the raw medications found in nature.
Pharmaceuticals and foodstuff ingredients are the main industries in which micronization is utilized. Particles with reduced diameters have higher dissolution rates, which increases efficacy. [ 9 ] Progesterone , for example, can be micronized by making very tiny crystals of the progesterone. [ 14 ]