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Terminologies used
in Pharmaceutical Industries
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Adenosine Triphosphate: ATP. A nucleotide present in all living cells that is involved in energy metabolism and required for RNA synthesis. ATP acts as an energy source and stores energy in the form of high-energy phosphate bonds. The free energy derived from hydrolysis of ATP is used to drive metabolic reactions including the synthesis of nucleic acids and proteins, to move molecules against concentration gradients, and to produce mechanical motion, such as the contraction of myofibrils and microtubules. Agglomeration: The act or process of collecting separate items into a mass; or, a cluster, heap, or mass of separate items. Amino Acid: Any of the nitrogenous organic acids that form proteins necessary for all life. An organic acid containing both a basic amino group and an acidic carboxyl group. Some amino acids can be polymerized to form peptides. Animal Micronutrient: A micronutrient required by an animal, such as chlorine, copper, or arsenic. Animal Nutrition: A branch of nutrition concerned specifically with animal nourishment. Aseptic Packaging Process: A packaging process which prevents the contamination of packaged items by infection-causing microorganisms. Binder: A substance that provides cohesion among particles along with some other desirable properties. These may include: mechanical strength; uniform consistency or solidification in the material to which it is added; or adhesion of a surface coating to a substrate. Blending: Mixing materials so thoroughly that they appear to be indistinguishable from each other in the product. Bottling: A process in which something, usually a liquid/powder, is put into or sealed in a bottle. Business development: The set of efforts for identifying, researching, analyzing and bringing to market new businesses and new products. Business development focuses on implementation of the strategic business plan through equity financing, acquisition/divestiture of technologies, products, and companies, plus the establishment of strategic partnerships where appropriate. Capsule: A small, soluble container, typically made of gelatin, that contains a dose of medicine; the capsule is usually taken orally. Capsule Packaging Process: The process of packaging pharmaceutical capsules. Chemical Analysis Extraction: Extraction that is a chemical analysis separation process in which a solid or solution is mixed with a liquid solvent in order to draw out one or more of the solid or solution components into the solvent. Chewable tablet: A tablet that may be chewed and swallowed. Compression process: A transformation process that reduces the size or magnitude of something without destroying its essential characteristics, as if by crowding or squeezing it. When the compression process is applied to compress transmitted information, that information may require decompression at the receiving end of the transmission. Consumer Product: A product designed to be used by a consumer, as compared to one designed to be used in the process of making a consumer product. The end product. Contract: An agreement, especially one that is legally enforceable, between two or more parties specifying an obligation to do or not do particular provisions. The many forms of contracts include conditional and open-ended contracts. Contract Manufacturer: A company that engages in product analysis, design and development, order fulfillment and product distribution, for another company, on a contract basis. Contract Manufacturing: The production of products/formulas on behalf of a client, in which the design and brand name belongs to the client. Controlled-Release Drug Delivery: A drug delivery method that dispenses substances into the body gradually. Current Good Manufacturing Practice: Good Manufacturing Practice implemented in 1976 for the manufacture of products that are under FDA jurisdiction, including pharmaceuticals, biological products and medical devices. Current Good Manufacturing Practice ensures that finished products have the correct identity, strength, quality and purity characteristics they are represented to have, and have not been altered during processing, packaging, or handling. It requires extensive use of documentation and strict reconciliation of inventory. Dietary allowance: The quantity of a specific nutrient which should be ingested within a specified time period to promote the normal growth and maintenance of an organism. Dietary Supplement: Physical material that is usually relatively richer in a specific nutrient than the average food or food product. It may contain one or a mixture of vitamins, proteins, minerals, and other growth stimulants. Dissolution: Mixing in which a solid or gas forms a chemical solution in a liquid. Dosage Form: The attribute describing how a medicine is prepared, such as tablet or liquid. Drug: A substance, such as a pharmaceutical product, used in or on the surface of the body to diagnose, cure, mitigate, treat, or prevent disease, or to otherwise affect the structure or function of the body. Drug Delivery Method: A specific procedure used for introducing drugs into the body. Drug Formulation: The act of developing or preparing a drug, or the final product itself. Drug Labeling Requirement: A requirement pertaining to the labeling of a drug product, especially concerned with communicating dosage and safety concerns. Drug Testing: Testing an organism or a substance for drug content. Dry Fine Powder Agglomeration: Agglomeration of dry, fine powders. Especially relating to agglomeration taking place in powder handling where agglomeration has a significant impact on the handling process. Dry Powder Blending: The process of blending powders in a dry state. Dye: Colorant which imparts a semi-permanent or permanent color to another material. Edible film: A film capable of being consumed by humans which is applied to various foods in order to lengthen the shelf-life. Effervescent Tablet: A tablet that uses effervescence to speed dissolution. Encapsulation: The process of surrounding, encasing, or enclosing in a capsule. Excipient: Inert material that is combined with an active drug in order to produce a drug dosage form. Food and Drug Administration Regulation: A regulation published by the FDA under Title 21 to enforce the statutory requirements of the Federal Food, Drug, and Cosmetic Act and its amendments. Food and Drug Administration Validation: The validation of something, such as a manufacturing process, to ensure that it is in compliance with Food and Drug Administration (FDA) regulations or requirements. Generic Drug Manufacturing: The process of manufacturing a drug whose name is not protected by a trademark. Good Laboratory Practice: A collection of detailed standards that mandate specific operating procedures that cover operating procedures for basic research, data acquisition and reporting. Also included are laboratory design and utilization requirements, such as finishes and number of air changes, which are enforced by regulatory agencies. GMP: Refers to the Good Manufacturing Practice Regulations. These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors. Granulation: The process of forming material into granules or grain-sized particles. HPLC: Refers to high-performance liquid chromatography; an advanced liquid chromatographic process that increases the scope of the technique. It enables researchers to separate peptides, amino acids, proteins, and other mixtures impossible to separate before. Labeling Process: The process of preparing or applying an identification marking which may be placed on an object. Labeling may be done for any of a variety of reasons, including product identification, ingredient listing, hazard warning, and nutrition information. Laboratory: A facility in which experimentation, analysis, or study may be conducted. Laboratory Procedure: A procedure used in a laboratory, such as a particular test or analytical procedure. Manufacturing: The making of goods/products, usually involving the use of machinery. Marketing: The system by which goods or services are transfered from a seller (especially a producer) to a buyer. May include advertising, selling, transportation, and storage. Metabolism: A biological process consisting of an integrated network of reactions by which living organized substance is produced and maintained, and also the transformation by which energy is made available for use by the organism. Microencapsulation: Encapsulation in capsules from well below 1 micrometer to over 2000 micrometers in diameter. Nutraceutical: A substance that may be considered a food or part of a food and provides improved nutrition leading to medical or health benefits, including the prevention and treatment of disease. Nutrient composition: The set of nutrient data, or a nutrient profile, for a food product. Nutrition: A branch of biology concerned with the study of the nutrients that each organism must obtain from its environment in order to sustain life and reproduce. Nutrition labeling: Food-product labeling including information on food value, such as vitamin and fat content. Nutrition Labeling and Education Act of 1990: A law enacted by the United States Congress in 1990 that makes nutrition labeling mandatory for all packaged food products and established a time frame in which it should be done. It charged the FDA with developing a program to educate consumers in how to read and utilize the new labels, and also charged them with developing the regulations that would go into the Code of Federal Regulations. Particle Fluidization: The mechanical process in which a solid is roasted at a level below its melting point resulting in decomposition into a suspension of finely divided particles in a rising current of fluid. Used in the calcination of minerals and in the coal industry. Peptide: An organic compound consisting of a chain of two or more amino acids linked together by peptide bonds. Peptide Synthesis: A biological or chemical process in which amino acids are added stepwise to a chain by the formation of a peptide bond between a carboxyl group on one amino acid and a free amino group on another amino acid. The formation of each peptide bond is energetically favorable because the growing carboxyl terminus is activated by the covalent attachment of a tRNA molecule. Pharmaceutical Color Additive: A color additive added or applied to a pharmaceutical to impart color to it. Pharmaceutical Design: The process of designing a pharmaceutically-useful chemical; that is, a chemical which is to be used as a pharmaceutical. Pharmaceutical Industry: Industry related to, or engaged in pharmacology or the manufacture and sale of pharmaceuticals. Pharmaceutical Manufacturing: Manufacturing of pharmaceutical products. Pharmaceutical Manufacturing Facility Auditing: Auditing a pharmaceutical manufacturing facility for compliance to regulations, such as Food and Drug Administration regulations. Pharmaceutical Research: Research that is conducted on a drug or for the purpose of developing a drug. Pharmaceutical technology: The technology associated with the development of new drugs. Pharmacology: The science dealing with the effect of drugs on living organisms. Pilot line: An assembly line that is small-scale and experimental and usually run after a new product design release in order to gain information regarding the production of the new product and its final design review. Pilot Plant Scale-Up: The scale-up process of a pilot plant. Polymer: A substance consisting of giant molecules formed from polymerization. Polymerization: A chaining together of many simple molecules to form a more complex molecule with different properties. Polymer Blending: The thorough chemical blending of (usually two) polymers, so that the mixture is homogeneous. Powder: Particulate material consisting of a loose aggregation of fine solid particles in which the average particle is smaller than 1 millimeter. Powder Coating Manufacturing: The process of manufacturing powder coating material. Included are the processes of premixing, extruding, grinding, clarification, blending, and packaging. Powder Coating Process: Coating where a powder material is coated onto a surface often using electrostatic or compressed air method. The applied powder is usually heated to its melting point, after which it flows to form a smooth film. Powder Segregation: Separation of a powder mixture into its constituent parts or separation according to size. Powder segregation may or may not be a desirable process. Procedure: A representation of a process that generally consists of a system of actions which, if carried out, are a process. Protein: An organic high polymer that is an amphoteric biopolymer consisting of amino acids joined by peptide linkages. Genetic code determines the order of the twenty possible amino acids used in protein synthesis, and thus the protein's structure and function. Protein may act as a structural component of a cell or tissue, as an enzyme, or as a hormone. Protein is involved in electron and oxygen transport, muscle contraction, and other bodily activities. Protein Concentration Process: The process of concentrating the amount of protein present in a sample, as by ultrafiltration. Protein Purification Method: A method, such as high-performance liquid chromatography (HPLC), gel filtration, or electrophoresis, which is used for purifying protein. Protein Synthesis: Synthesis of a protein, directed by the genetic code, which occurs by translation of mRNA into protein via tRNA. The ribosome attaches to the mRNA, using it as template. Quality: An attribute of a physical object, material, or process specifying its nearness to an ideal. Quality control: Control of product or service output quality by establishing quality level goals. Quality control often involves inspection, analysis, and action to make identified changes in order to maintain or achieve the required quality level. Compare with quality improvement, which involves taking actions to exceed the current required quality level, and quality assurance, which is the system of actions taken, such as inspection, to confidently assure that the product is of sufficient quality. Research and development: A process that integrates the processes of product research and development, shortening the cycle of commercial product development. Ribose: An aldopentose (5-carbon) monosaccharide, a building block of nucleic acids. It appears in three forms. Softgel Capsule: A small, soft, smooth container made from soft gelatin; it is most often used for drug delivery. Soy Protein: Protein or a mixture containing protein, in which the protein is isolated from soybeans. Sports nutrition: Nutrition geared toward the needs of people involved in sports. Sterile Packaging Process: A packaging process which ensures that the contents of the packaged product are sterile, that is, that there are no viable microorganisms or their spores. Tablet: A physical object resulting from a tableting process consisting of compacted powdered or granular material. Food products, vitamins, dyes, and fireworks are often produced in this form. Tableting: Compaction of powdered or granular material using a punch-and-die procedure. Tamper-Evident Closure: A package closure which is altered after the first opening so that it is evident, even after resealing, that the package has previously been opened. Testing: The process of measuring, analyzing, or evaluating the characteristics, capacities, attributes, or aptitudes of a substance, group, or individual. Test procedure: A procedure used to analyze, examine, or try a material or object, in order to determine certain characteristics such as the presence or quality of something. Veterinary Medicine: The branch of medical science applied to animals. Vitamin: An organic compound present in small amounts in natural foodstuffs. It often acts as a precursor of a required coenzyme and therefore is necessary for the normal processes of growth and maintenance of an organism. |
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