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| There are 121 entries in the glossary. |
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| "As-Built" Cleanroom | ISO 14644-1 defines the "as built" occupancy state as "condition where the installation is complete with all services connected and functioning but with no production equipment, materials, or personnel present". |
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| "At-Rest" Cleanroom | ISO 14644-1 defines "at rest" occupancy state as "condition where the installation is complete with equipment installed and operating in a manner agreed upon by the customer and supplier, but with no personnel present".
European Community (EC) defines "at rest" state as "the condition where the installation is complete with production equipment installed and operating but with no operating personnel present". The Medicines Inspectorate, however, further clarifies, "It should normally be taken to mean that ventilation systems are operating and other equipment is present in an operational condition but not in use". |
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| Acclimatization | The biological process whereby an organism adapts to a new environment. One example is the process of developing microorganisms that degrade toxic wastes in the environment |
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| Accommodation Schedule | Defines all areas that can influence unit operations required for manufacturing, and relationships and flows between them. |
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| Account Policy | Specifies how passwords must be defined and employed for all user accounts on a system. It specifically addresses the issues of password aging, password uniqueness, and locking a user account because of invalid logon attempts. CFR 21 Part 11 mandates technical controls in these areas specifically. |
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| Acid | A compound of an electronegative element or radical with hydrogen; it form salts by replacing all or part of the hydrogen with an electropositive element or radical. Or, a hydrogen-containing substance that when dissolved in water dissociates to produce one or more hydrogen ions (H+). |
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| Acid Feed | Injection of an acid into a liquid stream to make it less alkaline (pH adjustment). |
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| Action Point | A value set to identify when a parameter has drifted outside the operating range (Acceptance Criteria). A documented response is usually required. |
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| Activated Carbon | Material used to adsorb organic impurities from water. Derived from wood, lignite, pulp-mill char, blood, etc. The source material is initially charred at high temperature to convert it to carbon. The carbon is then "activated" by oxidation from exposure to high temperature steam. It comes in granular or powdered form. |
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| Active Immunity | The formation of an antibody that can be stimulated by infection or vaccination. |
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| Active Ingredient | Any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and are present in the drug product in a modified form intended to furnish the specified activity or effect. |
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| Active Site | The region of a protein molecule that binds the specific substrate and chemically modifies it into the new product (in an enzyme) or interacts with it (in a receptor). |
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| Active Transport | Energy-requiring transport of a solution across a membrane in the direction of increasing concentration. |
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| Actual Yield | The quantity that is actually produced at any appropriate phase of manufacture, processing, or packaging of a particular drug product. |
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| Adenine (A) | A purine base, 6-aminopurine, occurring in RNA (ribonucleic acid) and DNA (deoxyribonucleic acid) and as a component of adenosine triphosphate. |
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| ADR | see: Adverse Drug Reaction |
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| Adsorption | Adhesion of the molecules of a gas, liquid or dissolved substance to a surface because of chemical or electrical attraction - typically accomplished with granular activated carbon to remove dissolved organics and chlorine. The attachment of charged particles to the chemically active groups on the surface and in the pores of an ion exchanger. |
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| Adventitious Agents | Acquired, sporadic, accidental contaminants |
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| Adverse Agents | Undesired effects or toxicity due to exposure (often but not limited to a drug or medical device). |
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| Adverse Drug Reaction (ADR) | An undesirable effect that may be caused by a study drug |
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Glossary V2.0 |
