Glossary

This is a standard for how to specify a document mark-up language or tag set. SGML is not in itself a language, but a description of how to specify one. It is a meta language. HTML and XML are examples of SGML-based languages.

Leak penetration that would be detected by a discrete-particle counter or aerosol photometer with a standard sample flow-rate when the sampling probe is stationary over the leak. ISO 14644-3.NOTE: Penetration is the ratio of the particle number concentration downstream of the filter to the concentration upstream.

also see: Background medication, Concomitant Medication

Written procedures (prescribing and describing the steps to be taken in normal and defined conditions) which are necessary to assure control of production and processes.

Written and approved procedures to ensure that activities are performed the same way each time. A comprehensive SOP program must be in place in any regulated organization.

Detailed, written instructions to achieve uniformity of the performance of a specific function.

Instructions which specify how an activity is to be accomplished.

The description of necessary activities to respond to normal and abnormal situations in an operating system. The SOP may include a troubleshooting checklist, list of personnel to contact, etc. SOPs should also describe normal operation, maintenance, and cleaning of the system, and normal operating parameters. An SOP may be created for any system but an SOP must be created for each system requiring qualification.

The description of necessary activities to respond to normal and abnormal situations in an operating system. The SOP may include a troubleshooting checklist, list of personnel to contact, etc. SOPs should also describe normal operation, maintenance, and cleaning of the system, and normal operating parameters. An SOP may be created for any system but an SOP must be created for each system requiring qualification.

A wet or dry system of piping, valves, outlets, and related equipment designed to provide water at specified pressures and installed exclusively for the fighting of fires.

A type of indication created during the reaction of electrochemical etching process on the foreign or refractory material (dross) on the welds or base metal.

A complex insoluble carbohydrate, consisting of various proportions of two glucose polymers, amylose and amylopectin; the chief food storage substance of plants, which is composed of several hundred hexose sugar units and which easily breaks down on hydrolysis into these separate units.

The set of three nucleotides in an mRNA molecule with which the ribosome starts the process of translation. The start codon sets the reading frame for translation. The most commonly used start codon is AUG, which is decoded as methionine in eukaryotes and as N-formylmethionine in prokaryotes. AUG appears to be the only start codon used by eukaryotes, while in bacteria, GUG (valine) may sometimes be employed.

Act of preparing and bringing an installation into active service, including all systems.NOTE: Systems may include procedures, training procedures, training requirements, infrastructure, support services, statutory undertakings requirements. ISO 14644-4

The initial operation of equipment to prove that it is installed properly and operates as intended. Start-Up is considered complete when the selected equipment will adequately process product as specified.

(ICH Q3A (R2)) A material used in the synthesis of a new drug substance that is incorporated as an element into the structure of an intermediate and/or of the new drug substance. Starting materials are normally commercially available and of defined chemical and physical properties and structure.

(IEEE) A condition or mode of existence that a system, component, or simulation may be in; e.g., the pre-flight state of an aircraft navigation program or the input state of a given channel.

(IEEE) A diagram that depicts the states that a system or component can assume, and shows the events or circumstances that cause or result from a change from one state to another. Synonymous: State Graph.

(ICH Q10) A condition in which the set of controls consistently provides assurance of continued process performance and product quality.

A condition in which all operating variables that affect performance remain within such ranges that the system or process performs consistently and as intended.

A condition in which a pre-defined parameter is observed to remain within a pre-defined range of operation.

A representation of a state graph that specifies the states, the inputs, the transitions, and the outputs.