Glossary

(in relation to trials). Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements.

The practice of obeying rules or requests made by people in authority, e.g., adherence to certain specified standards such as regulations, good practices, SOPs, SLAs, or specified (user) requirements.

Any ingredient intended for use in the manufacture or packaging of a drug product.

An element within a system, such as a pump or a valve, on a piece of process equipment. Components can be critical or non-critical depending upon their potential impact on drug quality.

A structural material consisting of a combination of materials. Typically, one of the materials is a strengthening agent, the other being a thermoset or thermoplastic resin.

A casual name referring to a specific molecule.

These are chemical combinations of materials which include all the materials necessary for the finished product. They include BMC (Bulk Molding Compounds), SMC (Sheet Molding Compounds), and TMC (Thick Molding Compounds).

A chromosome formed by the union of two separate chromosomes, as in attached-X chromosomes or attached-X-Y chromosomes.

The process required to mix the polymer with all of the materials that are necessary to provide the end user with s finished product.

The bringing together into a homogenous mix of active ingredients, excipient and solvent components.

A material, or mixture of materials that are either liquefied, nonliquefied, or in solution having a boiling point of 68°F (20°C) or less at 14.7 psia (101.3 kPa) of pressure. The exceptions to this rule are those gases that have no health or physical hazard properties. These gases are not considered compressed until the pressure in their packaging exceeds 41 psia (282.5 kPa) at 68°F (20°C).

A fluid flow is compressible if its density "p" changes appreciably (typically by a few percent) within the domain of interest. Typically, this will occur when the fluid velocity exceed Mach 0.3 (326.24 ft/sec). Hence, low velocity flows (both gas and liquids) behave incompressibly.

Permanent deformation of rubber after subscription in compression for a period of time, as typically determined by ASTM D 395 (Standard Test Methods for Rubber Property – Compression Set).

A subdiscipline within Bioinformatics concerned with computation-based research devoted to understanding basic biological processes.

The use of applied mathematics, physics and computational software to visualize how a gas or liquid flows -- as well as how the gas or liquid affects objects as it flows past. Computational fluid dynamics is based on the Navier-Stokes equations.

(IEEE) A functional unit that can perform substantial computations, including numerous arithmetic operations, or logic operations, without human intervention during a run.

A functional programmable unit that consists of one or more associated processing units and peripheral equipment, that is controlled by internally stored programs, and that can perform substantial computations, including numerous arithmetic operations, or logic operations, without human intervention.

The use of computers to design products. CAD systems are high-speed workstations or personal computers using CAD software and input devices such as graphic tablets and scanners to model and simulate the use of proposed products. CAD output is a printed design or electronic output to CAM systems. CAD software is available for generic design or specialized uses such as architectural, electrical, and mechanical design. CAD software may also be highly specialized for creating products such as printed circuits and integrated circuits.

The automation of manufacturing systems and techniques, including the use of computers to communicate work instructions to automate machinery for the handling of the processing [numerical control, process control, robotics, material requirements planning] needed to produce a workpiece.

An automated system for the support of software development including an integrated tool set, i.e., programs, which facilitate the accomplishment of software engineering methods and tasks such as project planning and estimation, system and software requirements analysis, design of data structure, program architecture and algorithm procedure, coding, testing and maintenance.

Computer system plus its controlled function.

(ANSI) A complete set of the operators of the instructions of a computer together with a description of the types of meanings that can be attributed to their operands. Synonym: Machine Instruction Set.