Glossary

A matrix that records the relationship between two or more products; e.g., a matrix that records the relationship between the requirements and the design of a given software component.

Reticulo Endothelial system

A medicinal product used to manage the subject’s treatment when the efficacy of the IMP is either over expressed or under expressed resulting in a safety concern to the subject.

A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Organic volatile chemicals that are used or produced in the manufacture of drug substances or excipients, or in the preparation of drug products. The solvents are not completely removed by practical manufacturing techniques.Residual solvents assessed in the ICH guidance have been grouped by class as follows:Class 1 solvents: Solvents to be avoided – Known human carcinogens, strongly suspected human carcinogens, and environmental hazards.Class 2 solvents: Solvents to be limited – Nongenotoxic animal carcinogens or possible causative agents of other irreversible toxicity such as neurotoxicity or teratogenicity.Class 3 solvents: Solvents with low toxic potential – Solvents with low toxic potential to man; no health-based exposure limit is needed. Class 3 solvents have PDE’s of 50 milligrams (mg) or more per day.

A single amino acid within a protein.

Ion exchange resins are usually bead-like spherical materials with an affinity for particular ions. Cation exchange resins made of styrene and divinylbenzene containing sulfonic acid groups will exchange hydrogen ions for any cations they encounter. Similarly, anion exchange resins made of styrene and divinylbenzene containing quaternary ammonium groups will exchange a hydroxyl ion for any anions.

Any of several solid or semisolid inflammable substances, of natural or synthetic organic origin; usually translucent polymers that do not conduct, that break like glass, and that are soluble in ether, alcohol, and essential oils but not in water. The word is used generically to describe chromatographic media, particularly polymer beads.

Term commonly used to describe the ability of an organism to withstand a stress, a force or an effect of a disease, or its agent or a toxic substance.

The pressure drop across a filter at a stated flow and under given conditions; generally expressed in millimeters water gauge or PSI, or in SI units as N/m² or Pascals.

A type of welding process in which the work pieces are heated by the passage of an electric current through the contact. Such processes include spot welding, seam or line welding and percussion welding. Flash and butt welding are sometimes considered as resistance welding processes.

The reciprocal of conductivity (R=1/C). A measure of specific resistance to the flow of electricity. In water, provides an easy mean of continuously measuring the purity of very low Total Dissolved Solids (TDS), or ionic concentration. The fewer the dissolved ions in water, the higher its resistivity. Resistivity is normally expressed in Megohm-cm (Mohm-cm) and is equivalent to one million ohms of resistance measured between two electrodes one centimeter apart. The theoretical maximum ionic purity of water is 18.3 Megohm-cm at 25°C.

The measure of the resistance to the flow of electrical current through high purity water. This is measured in millions of ohms-cm or Megohm-cm (Mohm-cm). Resistivity is the reciprocal of Conductivity (R=1/C, 1 Mohm-cm = 1 µS/cm). This provides an easy means of continuously measuring the purity of very low TDS water or ionic concentration.

The measure of the resistance to the flow of electrical current through high purity water. This is measured in millions of ohms-cm or Megohm-cm (Mohm-cm). Resistivity is the reciprocal of Conductivity (R=1/C, 1 Mohm-cm = 1 µS/cm). This provides an easy means of continuously measuring the purity of very low TDS water or ionic concentration.(also see: Conductivity)

In chromatography, the quality of separation measured in terms of the purity of the resulting component fractions (higher resolution means greater purity).

Degree of molecular detail on a physical map of DNA, ranging from low to high.

Management of resources, including machines, tools, labor skills, materials, other equipment, and other entities, such as documents that must be available in order for work to start at the operation. It provides detailed history of resources and insures that equipment is properly set up for processing and provides status real time. The management of these resources includes reservation and dispatching to meet operation scheduling objectives.

Allocation of people or materials required to complete a task as identified within a schedule.

An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and that persons with diminished autonomy be protected.

A device worn to prevent inhalation of hazardous substances.

An advanced aseptic processing system that can be utilized in many applications in a fill-finish area. RABS provides an enclosed environment to reduce the risk of contamination to product, containers, closures, and product contact surfaces compared to the risks associated with conventional cleanroom operations. RABS can operate as “doors closed” for processing with very low risk of contamination similar to isolators, or permit rare “open door interventions” provided appropriate measures are taken.

An aseptic processing system that provides an enclosed, but not closed, environment meeting Grade 5 conditions utilizing a rigid-wall enclosure and and air overspill to separate its interior from the surrounding environment.• RABS, ActiveRABS using an integral HEPA-filtered air supply to the critical area and manual high-level disinfection, usually with Sporicidal agents. Gloves and transfer ports are used for manipulation and commodity addition.• RABS, PassiveRABS wherein the airflow to the critical area is provided by ceiling-mounted HEPA filters extending laterally outside the enclosure, and the bottom of the enclosure is open to provide for air flow through the system. Gloves and transfer ports are used for manipulation and commodity addition.

A class of endonucleases that cleaves DNA after recognizing a specific sequence, e.g., BamH1(5’GGATCC3’), EcoRI (5’GAATTC3’), and HindIII (5’AAGCTT3’). There are three types of restriction endonuclease enzymes:Type I: Cuts non-specifically a distance greater than 1000 bp from its recognition sequence and contains both restriction and methylation activities.Type II: Cuts at or near a short, and often palindromic (q.v.) , recognition sequence. A separate enzyme methylates the same recognition sequence. They may make the cuts in the two DNA strands exactly opposite one another and generate blunt ends, or they may make staggered cuts to generate sticky ends. The type II restriction enzymes are the ones commonly exploited in recombinant DNA technology.Type III: Cuts 24-26 bp downstream from a short, asymmetrical recognition sequence. Requires ATP and contains both restriction and methylation activities.

A specific nucleotide sequence of DNA at which a particular restriction enzyme cuts the DNA. Some sites occur frequently in DNA (e.g., every several hundred base pairs), others much less frequently (rarecutter; e.g., every 10,000 base pairs).