Glossary

Steam-In-Place

small interfering Ribonucleic Acid

Styrene-Isoprene-Styrene (block copolymer)

Strength, Identity, Safety, Purity, and Quality

Synonyms: clinical site/center/clinic/unit/hospital participating in a clinical trial.

A managerial entity, which may be topological in regard to production sites, generally dealing with a number of isolated intermediates or finished products.

(IEEE) An acceptance Test at the Customer’s site, usually involving the Customer.

Inspection and /or dynamic testing of the systems or major system components to support the qualification of an equipment system conducted and documented at the manufacturing site.

A visit by agency officials, representatives, or consultants to the location of a research activity to assess the adequacy of IRB protection of human subjects or the capability of personnel to conduct the research.

A term used to describe any process or enzyme which acts at a defined sequence within a DNA or RNA molecule. Type II restriction enzymes are site-specific endonucleases and the recombination systems encoded by some transposons are site-specific, such as is the integration of phage into the E. coli chromosome.

Simian Immunodeficiency Virus

A type II restriction endonuclease that binds (and subsequently cleaves) DNA at sites that contain a sequence of six nucleotide pairs that is uniquely recognized by that enzyme. Because any sequence of six bases occurs less frequently by chance than any sequence of four bases, six-base cutters cleave less frequently than do four-base cutters. Thus, six-base cutters create larger fragments than four-base cutters.

The size of surface deficits is classified in two groups: macro, referring to indications that can be seen in adequate lighting without magnification, and micro, referring to indications that can be seen only with the aid of magnification.

(IEEE) The process of estimating the amount of computer storage or the number of source lines required for a software system or component.

(IEEE) A software V&V task to obtain program sizing and execution timing information to determine if the program will satisfy processor size and performance requirements allocated to software.

Skid mounted equipment is a processing unit operation, which is generally an independent piece of equipment designed for a specific processing step in the production of a pharmaceutical product. Examples include equipment such as a tablet press, depyrogenation tunnel, or a lyophilizer.

Stock Keeping Unit

Spectral Karyotype

Service Level Agreement

A concentration of nonmetallic impurities (often oxides or nitrides) that forms in the weld pool and solidifies on the underbead or weld top surface.

System Level Impact Assessment

An incline or deviation from the horizontal. A tube or pipe installed in the horizontal plane is said to slope if one end is positioned higher than the other.

Styrene Maleic Anhydride

Sheet Metal and Air Conditioning Contractors National Association