Glossary

Initially designed to help AIDS patients, parallel tracking makes drugs showing promising results in phase III of the IND process available to patients whose condition prevents them from participating in controlled clinical trials. Parallel tracking is similar to the treatment IND, a program started several years earlier.

(IEEE) A constant, variable or expression that is used to pass values between software modules. Synonymous: Argument.

Control of a parameter implies action to keep the parameter measurement within acceptance limits.

Monitoring a parameter verifies the value of the parameter has been measured, indicated, recorded, and perhaps alarmed.

A system of release that gives the assurance that the product is of the intended quality based on information collected during the manufacturing process and on the compliance with specific GMP requirements related to Parametric Release.

An organism deriving its food from the living body of another organism.

(ICH Q5D) Cell to be manipulated to give rise to a cell substrate or an intermediate cell line. For microbial expression systems, it is typical to also describe the parental cells as the host cell. For hybridomas, it is typical to also describe the parental cells as the cells to be fused.

A parenteral drug is defined as one intended for injection through the skin or other external boundary tissue, rather than through the alimentary canal, so that active substances they contain are administered, using gravity or force, directly into a blood vessel, organ, tissue, or lesion. They are infused when administered intravenously (IV), or injected when administered intramuscularly (IM), or subcutaneously into the human body. A large volume parenteral (LVP) is a unit dose container of greater than 100 ml that is terminally sterilized by heat. Small volume parenteral (SVP) is a “catch-all” for all non-LVP parenterals products except biologicals. A small volume parenteral is a unit dose container of less than 100 ml.

A parenteral drug is defined as one intended for injection through the skin or other external boundary tissue, rather than through the alimentary canal, so that active substances they contain are administered, using gravity or force, directly into a blood vessel, organ, tissue, or lesion. They are infused when administered intravenously (IV), or injected when administered intramuscularly (IM), or subcutaneously into the human body. A large volume parenteral (LVP) is a unit dose container of greater than 100 ml that is terminally sterilized by heat. Small volume parenteral (SVP) is a “catch-all” for all non-LVP parenterals products except biologicals. A small volume parenteral is a unit dose container of less than 100 ml

A Pareto diagram is related to pareto’s Law: 80 percent of the problems come from 20 percent of the issues (this is also known as the “80/20 rule”). A Pareto diagram illustrates problems by assigned cause, from smallest to largest.

Injection of gas below the water surface to remove other dissolved gases and volatile organic compounds.

The hollow melted plastic tube extruded from the die head of a blow molding machine. The parison is expanded within the mold by air pressure to form a container.

An error detection method in data transmissions that consists of selectively adding a 1-bit to bit patterns (word, byte, character, message) to cause the bit patterns to have either an odd number of 1-bits (odd parity) or an even number of 1-bits (even parity).

(ISO) A binary digit appended to a group of binary digits to make the sum of all the digits, including the appended binary digit, either odd or even, as predetermined.

(ISO) A redundancy check by which a recalculated parity bit is compared to the predetermined parity bit.

A common progressive neurological disorder that results from degeneration of nerve cells in a region of the brain that controls movement. The first symptom of the disease is usually tremor of a limb, especially when the body is at rest.

Production of an embryo from an unfertilized egg.

Solid or liquid object that falls within a cumulative distribution that is based upon a threshold (lower limit) size in the range from 0,1 µm to 5 µm.

Minute piece of matter with defined physical boundaries.

Number of individual particles per unit volume of air. ISO 14644-1.

Airborne particle count of both viable (living) organisms and non-viable (inert) particles. [Measured in PCF (particles per cubic foot) (multiply by ~35.3 to obtain particles per cubic meter)].

Technique used to filter macro particles, which are visible to the naked eye and range in size from 50µm to 1,000µm. Examples of particles in this size range include beach sand, granular activated carbon, human hair, mist, pollen, and milled flour.

Diameter of a sphere that produces a response, by a given particle-sizing instrument, that is equivalent to the response produced by the particle being measured. ISO 14644-1, ISO 14644-3.NOTE: For discrete-particle counting, light-scattering instruments, the equivalent optical diameter is used.

The apparent maximum linear dimension of a particle in the plane of observation as seen with a microscope or the equivalent diameter of a particle detected by automatic instrumentation.