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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).
Process engineering activities can be divided into the following disciplines: [7] Process design: synthesis of energy recovery networks, synthesis of distillation systems (), synthesis of reactor networks, hierarchical decomposition flowsheets, superstructure optimization, design multiproduct batch plants, design of the production reactors for the production of plutonium, design of nuclear ...
TGA – Thermogravimetric analysis; TIKA – Transmitting ion kinetic analysis; TIMS – Thermal ionization mass spectrometry; TIRFM – Total internal reflection fluorescence microscopy; TLS – Photothermal lens spectroscopy, a type of photothermal spectroscopy; TMA – Thermomechanical analysis; TOF-MS – Time-of-flight mass spectrometry
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.
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.
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies.Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, [1] cosmetics, [2] pharmaceutical products, [3] dietary supplements, [4] and medical devices. [5]
This could include packaging components such as folding cartons, shipping cases, labels or even phase change material. All of these components must have some type of random inspection to ensure that the third party manufacturer's process is consistently producing components that are used in the world of GMP at drug or biologic manufacturer.
Chemical engineers design, construct, and operate process plants, such as these fractionating columns.. Chemical engineering is an engineering field which deals with the study of the operation and design of chemical plants as well as methods of improving production.