Glossary

Wash in Place (Integrated automated cleaning method)

Work In Progress Laboratory

World Intellectual Property Organization

In a trial, to end a patient’s participation before he or she reaches the designated end point.

A recall of a lot of product that is done voluntarily by a firm, when there is concern about product quality that is not proven. A recall may be mandated by FDA or regulatory bodies.

Contamination-sensitive material of defined surface area used in lieu of direct evaluation of a specific surface that is either inaccessible or too sensitive to be handled.

Warehouse Management System

Work Order

An explanation of how one tRNA may recognize more than one codon. The first two bases of the mRNA codon has some wobble that permits it to pair with more than one base.

A rare autosomal recessive disorder that leads to many different abnormalities, including diabetes mellitus, deafness, and blindness. Patients usually also suffer from severe abnormalities of the nervous system that can be accompanied by behavior problems, psychiatric hospitalizations, and, in 25 percent of cases, suicide attempts.

A simplification of a project to list of tasks with start and end dates and milestones.

The name given to materials that are in the process of being converted into finished product.

A sequence of actions the user should take to avoid a problem or system limitation until the computer program is changed. They may include manual procedures used in conjunction with the computer system.

A culture of cells derived from the master cell bank (master cell seed) and intended for use in the preparation of production cell cultures. The working cell bank (working cell seed) is distributed into containers, processed and stored as described for the master cell bank (master cell seed).

(ICH Q5A (R1)/Q5B/Q5D) The WCB is prepared from aliquots of a homogeneous suspension of cells obtained from culturing the MCB under defined culture conditions.

A culture of a microorganism derived from the master seed lot and intended for use in production. Working seed lots in liquid form are distributed into containers and usually stored at or below -70°C.

The nominal design volume of a vessel. In a vertical vessel, this level will always be located below the top head weld seam.

Any terminal or personal computer.

An open or enclosed work surface, usually with direct air supply.

Write Once Read Many

An independent program which can travel from computer to computer across network connections replicating itself in each computer. They do not change other programs, but compromise a computer system through their impact on system performance.

The highest or lowest value of a given control parameter actually evaluated in a validation exercise.

Testing which encompasses upper and lower limits, and circumstances which pose the greatest chance finding of errors.Synonymous: Most Appropriate Challenge Conditions. (also see: Testing, Integration)