Glossary

(ICH Q1A (R2)) Containers that allow the passage of solvent, usually water, while preventing solute loss. The mechanism for solvent transport occurs by absorption into one container surface, diffusion through the bulk of the container material, and desorption from the other surface. Transport is driven by a partial-pressure gradient. Examples of semi-permeable containers include plastic bags and semi-rigid, low-density polyethylene (LDPE) pouches for large volume parenterals (LVPs), and LDPE ampoules, bottles, and vials.

The involved disciplines at an organization where a designated product, process, or method is expected to be transferred from.

The last stage in the post-embryonic development of multicellular organisms, during which loss of functions and degradation of biological components occur. A physiological ageing process in which cells and tissues deteriorate and finally die.

(ICH Q10) Person(s) who direct and control a company or site at the highest levels with the authority and responsibility to mobilize resources within the company or site. (ICH Q10 based in part on ISO 9000:2005)

Heat that causes a change of temperature without causing a change of state.

The ratio of room sensible heat to room total heat as expressed in the formula:Sensible Heat ratio (SHR) = Room Sensible Heat (SH)/Room Total Heat (TH)

A measure of prediction that is equivalent to one minus the false-negative rate.

A chemical that causes a substantial proportion of exposed people or animals to develop an allergic reaction in normal tissue after repeated exposure to the chemical.

A compound that can cause immediate (IgE-mediated) or delayed (cel-mediated) hypersensitivity reactions.

A peripheral input device which senses some variable in the system environment, such as temperature, and converts it to an electrical signal which can be further converted to a digital signal for processing by the computer.

Acquisition of the product from the process stream, leaving contaminants and impurities. A centrifuge is most commonly used for separation.

Numerical abbreviation summarizing the difference in cleanliness classification between two areas as ensured by a separative enclosure under defined test conditions, where: A = ISO class inside; a = particle size at which A is measured; B = Iso class outside; b = particle size at which B is measured. ISO 14644-7.

Equipment utilizing constructional and dynamic means to create assured levels of separation between the inside and outside of a defined volume.NOTE: Some industry-specific examples of separative devices are clean air hoods, containment enclosures, gloveboxes, isolators and mini-environments.

Styrene-Ethylene/Propylene-Styrene (block copolymer)

The presence of various pus forming and other pathogenic organisms or their toxins in the blood or tissues; septicemia.

A detailed description of the system start-up, normal operation and cleaning (as applicable), process monitoring, data acquisition and archive, alarm conditions and response, and shutdown

Short (200 to 500 base pairs) DNA sequence that has a single occurrence in the human genome and whose location and base sequence are known. Detectable by polymerase chain reaction, STSs are useful in chromosome placement, mapping and sequencing data reported from many different laboratories, and serve as landmarks on the developing physical map of the human genome. Expressed sequence tags (ESTs) are STSs derived from cDNAs.

Determination of the order of nucleotides (base sequences) in a DNA or RNA molecule or the order of amino acids in a protein. Sequencing a gene can require analyzing an average of 40,000 nucleotides.

One of the plural forms of serum.

Spongiform Encephalopathy Research Campaign

Pertaining to the sequential processing of the individual parts of a whole, such as the bits of a character or the characters of a word, using the same facilities for successive parts.

Term describing the transmission of data one bit at a time.

A quantitative expression assay that is based on tags that are 10-20 bp in length, which are derived from mRNAs.

A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect, or precaution. A serious adverse event includes any experience that:1.It is life threatening2.It is permanently disabling3.Requires inpatient hospitalization4.Prolongs hospitalization5.(For drugs) results in congenital anomaly, cancer or overdose