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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).
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 ]
Material flow accounts provide information on the material inputs into, the changes in material stock within, and the material outputs in the form of exports to other economies or discharges to the environment of an economy. Material flow accounting can be used in national planning, especially for scarce resources, and also allows for forecasting.
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.
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 ...
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.
With stability testing, pharmaceutical industry inspects the quality of drug substances and drug products as per the guidelines outlined by US Food and Drug Administration and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to make sure that they retained the quality over the period of time.
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.