Glossary

Engineering and Physical Sciences Research Council (United Kingdom)

Of, pertaining to, or characteristic of a horse, such as equine hormones.

Equipment encompasses the physical entities necessary to complete a major step of a recipe step, e.g., a reactor, a crystallizer, a dryer, a separation column, a packager, or a centrifuge.

Apparatus used to conduct the required process or test.For the purpose of this Guide (ISPE GPG Assessing the Particulate Containment Performance of Pharmaceutical Equipment) the term “equipment” is used, e.g., in “emissions from the equipment”, to refer either to a piece of process equipment (e.g., a mill or a centrifuge) or to a containment system (e.g., a glovebox, a downflow booth, laminar air flow booth, containment by air entrainment device, or local exhaust device).

A functional group of equipment that can carry out a finite number of specific minor processing activities.

The established capacity of process equipment and ancillary systems to operate consistently within established limits and tolerances.

Fair or just; used in the context of selection of subjects to indicate that the benefits and burdens of research are fairly distributed. 45CFR46.111 (a)(3)

(Myers) Partitioning the input domain of a program into a finite number of classes (sets), to identify a minimal set of well selected test cases to represent these classes. There are two types of input equivalence classes, valid and invalid.

Electronic Records

Electronic Records/Electronic Signatures

Electronic Records and Signatures

Chips which may be programmed by using a PROM programming device. Before programming each bit is set to the same logical state, either 1 or 0. Each bit location may be thought of as a small capacitor capable of storing an electrical charge. The logical state is established by charging, via an electrical current, all bits whose states are to be changed from the default state. EPROMs may be erased and reprogrammed because the electrical charge at the bit locations can be bled off (i.e. reset to the default state) by exposure to ultraviolet light through the small quartz window on top of the IC. After programming, the IC's window must be covered to prevent exposure to UV light until it is desired to reprogram the chip. An EPROM eraser is a device for exposing the IC's circuits to UV light of a specific wavelength for a certain amount of time.

A conical flat-bottomed laboratory flask with a narrow neck, designed by E. Erlenmeyer. Widely used for culturing micro-organisms.

Electronic Records Management System

Enterprise Resource Planning

(ISO) A discrepancy between a computed, observed, or measured value or condition and the true, specified, or theoretically correct value or condition.

Techniques used to identify errors in data transfers.

(NBS) Test data selection technique. The selection criterion is to pick values that seem likely to cause errors.

(IEEE) The process of intentionally adding known faults to those already in a computer program for the purpose of monitoring the rate of detection and removal, and estimating the number of faults remaining in the program.

Quantified doubt about the result of a measurement.

Electronic Routing System (CBER)

Endotoxin Reduced Water