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"| There are 121 entries in the glossary. |
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| Antibiotic | An organic substance of microbial origin (usually mold or actinomycete bacteria) that is either toxic or growth inhibiting for other organisms. Also with the advent of synthetic methods of production, a substance produced by a microorganism or a similar substance (produced wholly or partly by chemical synthesis) which, in low concentrations, inhibits the growth of other microorganisms. Penicillin, tetracycline, and erythromycin are examples of antibiotics |
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| Antibody | A modified protein molecule present in the blood serum or plasma (and other body fluids), whose activity is associated chiefly with gamma globulin. Produced by the immune system in response to exposure to a foreign substance, it is the body's protective mechanism against infection and disease. An antibody is characterized by a structure complementary to the foreign substance, the antigen that provokes its formation, and is thus capable of binding specifically to the foreign substance to neutralize it. |
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| Antigen | Any of various foreign substances such as bacteria, viruses, endotoxins, exotoxins, foreign proteins, pollen, and vaccines, whose entry into an organism induces an immune response (antibody production, lymphokine production, or both) directed specifically against that molecule. Response may be demonstrated as an increased reaction, such as hypersensitivity (usually protein or a complex of protein and polysaccharide, or occasionally a polysaccharide of high molecular weight), a circulating antibody that reacts with the antigen, or some degree of immunity to infectious disease if the antigen was a microorganism or its products. |
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| Antiseptic | Acting against sepsis. An antiseptic agent is one that has been formulated for use on living tissue such as mucous membranes or skin to prevent or inhibit growth or action of organisms. Antiseptics should not be used to decontaminate inanimate objects. |
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| Antiserum | The blood serum obtained from an animal after has been immunized with a particular antigen. It contains antibodies specific for that antigen as well as antibodies specific for any other antigens with which the animal has previously been immunized. |
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| Antistatic | Reducing static electric charges by retaining enough moisture to provide electrical conduction |
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| Antistatic Cleaners | Liquid cleaners that enhance surface conductivity of cleanroom tabletops, workstations, and other surfaces. |
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| Antitoxin | An antibody that is capable of neutralizing the specific toxin that stimulated its production in the body. Antitoxins are produced in animals for medical purposes by injection of a toxin or toxoid, with the resulting serum being used to counteract the toxin in other individuals. |
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| API (Active Pharmaceutical Ingredient) | Also called Drug Substance. Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that when used in the production of a drug becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body. |
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| API Starting Material | A material used in the production of an API which is itself or is incorporated as a significant structural fragment into the structure of the API. A starting material may be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or it may be produced in-house. Starting materials are normally of defined chemical properties and structure. |
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| Apoenzyme | The protein moiety of an enzyme - determines the specifity of the enzyme reaction.
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| Application Software | Any executable program developed or modified specially for customer applications |
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| Appropriated login or Impersonation | Someone using the authorization code, usually user ID and password of another person to secure access to network resources for which he or she does not have privileges or authorization. Can be intentional or not. CFR 21 Part 11 mandates technical controls that prevent this. |
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| Aquifer | An underground layer of permeable rock, sand, or gravel that contains water for wells or springs. |
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| Arithmetic Average Roughness (Ra) | The arithmetic average height of roughness component irregularities from the mean line measured within the sample length (L). This measurement conforms to ANSI/ASME B46.1 "Surface Texture - Surface Roughness, Waviness and Lay". Ra (formerly known as AA or Arithmetic Average in the U.S., and CLA Centerline Average in the U.K.) is usually expressed in microinches (µin), and performed by moving a stylus or profilometer in a straight line along the surface. A consistent and measurable surface finish can be specified for a desired roughness i.e., 9-11 microinch. |
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| Ascomycetes | A family of fungi marked by long spore-containing cells. Form sexual spores called ascospores, which are contained within a sac (a capsule structure). Ergot, truffles, some molds of the genera Neurospora and Aspergillus, and yeasts belong to this category. |
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| Asepsis | A condition in which living pathogenic (causing or capable of causing disease) organisms are absent. |
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| Aseptic | Marked by or relating to asepsis. |
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| Aseptic Processing | Processing conditions designed to achieve a sterile product. |
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| Aseptic Processing Area | Area in which sterile product is formulated, filled into containers, and sealed. |
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Glossary V2.0 |
