Glossary

In water monitoring systems – Compared to Phase 3 of the ISPE C&Q GPG, in general terms this sampling phase allows for the system to be challenged by evaluating its effectiveness in delivering water of acceptable quality despite seasonal variations of the potable water feed to the system, the slow development of the mature system’s natural flora, and any other variations that may occur. Its duration may continue for not less than one year (subtracting Initial and Intermediary phases).(also see: Initial, Intermediary Sampling)

Simple, very flexible text format derived from SGML and standardized (ISO 8879). Originally designed to meet the challenges of large-scale electronic publishing, XML also is playing an increasingly important role in the exchange of a wide variety of data on the Web and elsewhere.

Simple, very flexible text format derived from SGML and standardized (ISO 8879). Originally designed to meet the challenges of large-scale electronic publishing, XML also is playing an increasingly important role in the exchange of a wide variety of data on the Web and elsewhere.

Away from all manufacturing-related activities where normal clothing would be worn (e.g., restaurant).

The irreversible condition of a species or other group of organisms of having no living representatives in the wild, which follows the death of the last surviving individual of that species or group. Extinction may occur on a local or global level; it can result from various human activities, including the destruction of habitats or the overexploitation of species that are hunted or harvested as a resource.

Self-replicative genetic elements separate from main chromosome(s) of a cell. This definition usually excludes viruses, but the division is somewhat arbitrary. In bacteria, plasmids are the principal extrachromosomes; they encode functions which are not essential to the growth and division of the host cell. In eukaryotes, extrachromosomes may be either essential or dispensable. They may inhabit (i) the nucleus, e.g., extrachromosomal rDNA molecules, yeast 2 micrometer plasmid; (ii) the cytosol, e.g., dsRNA molecules in fungi; or (iii) the cytoplasmic organelles, e.g., mitochondrial DNA, chloroplast DNA. Eukaryotic extrachromosomal elements may be recognized genetically by their failure to show segregation at meiosis.

A solution that contains solvent and extractables.

Trace material from piping and/or equipment which have been extracted by the processed fluid.

Undesirable foreign substances that are leached or dissolved by water or process streams from the materials of construction used in filters, storage vessels, distribution piping, and other product contact surfaces.

Small quantities of chemical compounds and elements, not intentional components of the process stream, that are capable of being extracted by product-containing solutions from the surfaces of pharmaceutical production process equipment.

Undesirable foreign substances that are leached or dissolved by water or process streams from the materials of construction used in filters, storage vessels, distribution piping, and other product contact surfaces.

Undesirable foreign substances that are leached or dissolved by water or process streams from the materials of construction used in filters, storage vessels, distribution piping, and other product contact surfaces.(also see: Leachables)

A solvent used to extract a substance.

Liquid-liquid extraction is a process in which a solute is removed from a liquid by transferring the solute into a second liquid phase. The two liquid phases must be immiscible (insoluble) to each other. The separation is based on different solubilities of the solute in the two phases. Extraction is gentle, suitable for unstable molecules.

(EMEA – CHMP) Testing that specifically involves exposing a sample of the component to an appropriate solvent system at extreme conditions in order to maximize the amount of extractables from the packaging in the solvent.

(ICH Q3A (R2)) An impurity arising from any source extraneous to the manufacturing process.

(NBS) Test data that is at the extreme or boundary of the domain of an input variable or which produces results at the boundary of an output domain.

Microorganisms that live at extreme levels of pH, temperature, pressure and salinity.

The process of forming a continuous piece of plastic by forcing it through a shaping orifice with or without the presence of heat.