Glossary

Point in a controlled environment at which control is applied and a hazard can be prevented, eliminated or reduced to acceptable levels.

An operating system. A registered trademark of Digital Research.

Serum used as a standard for clinical chemistry lab tests. Most often produced from outdated whole blood plasma. Most often turbid and difficult to filter.

(CMC-BWG) Region within the design space that defines the operational limits (for process parameters and input variables) used in routine manufacturing. The control space can be a multidimensional space or a combination of univariate process ranges.

(ICH Q8 (R2)/Q10) A planned set of controls, derived from current product and process understanding that ensures process performance and product quality. The controls can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control.

Faclity space with restricted access and operated to restrict introdudction of potential contamination, consequences of accidental release of airborne contaminants.

An area constructed and operated in such a manner that some attempt is made to control the introduction of potential contamination, and the consequences of accidental release of living organisms. The level of control exercised should reflect the nature of the organism employed in the process. At a minimum, the area should be maintained at a pressure negative to the immediate external environment and allow for the efficient removal of small quantities of airborne contaminants.

Area of restricted access. A term for areas and rooms adjoining a critical area in aseptic production facilities.

Controled cold temperature is defined as temperature maintained thermostatically between 2º and 8ºC (36º and 46ºF), that allows for excursions in temperature between 0º and 15ºC (32º and 59ºF) that may be experienced during storage, shipment, and distribution such that the allowable calculated mean kinetic temperature is not more than 8ºC (46ºF).

Narcotic drugs and psychotropic substances regulated by provisions of national drug laws.

Defined zone in which sources of contamination are controlled by specified means.

The environment in which parameters, such as light, temperature, relative humidity and sometimes the partial gas pressure, are fully controlled.

An area without airborne particle limits, but with filtered ventilation.

A non-classified room environment where closed processes and their immediate support systems may be located. CNC space is cleanable, access controlled and served with filtered ventilation air; procedural controls and personnel garment upgrades may be applied at the Owner’s discretion. In the biopharmaceutical industry CNC is replacing the term “Gray Space”.

Controled room temperature indicates a temperature maintained thermostatically that encompasses the usual and customary working environment of 20º to 25ºC (68º to 77ºF); that results in a mean kinetic temperature calculated to be no more than 25 ºC; and tha allows for excursions between 15º and 30º (59º and 86ºF) that are experienced in pharmacies, hospitals, and warehouses.

Hardware that controls peripheral devices such as a disk or display screen. It performs the physical data transfers between main memory and the peripheral device.

In eukaryotes, transposable elements which control the activity of standard genes. A controlling element may, in the simplest case, inhibit the activity of a gene through becoming integrated in, or close to, that gene. Occasionally, either in germinal or somatic tissue, it may be excised from this site, and due to excision the activity of the gene is more or less restored, while the element may become reintegrated elsewhere in the genome where it may affect the activity of another gene. For example, in maize, a controlling element such as Ac or Ds is capable of influencing the expression of a nearby gene.

Continental United States

New compounds made up by chemical synthesis or fermentation. These are termed by the FDA as NCEs (New Chemical Entities). The FDA rates conventional drugs with important therapeutic gain as 1-A drugs, for priority review. For example, AIDS drugs are conventional drugs approved for AIDS or AIDS-associated conditions.

A room supplied with filtered air with no specified requirement for uniform airflow patterns or velocity. Flow patterns are usually turbulent.

Also known as immediate-release dosage forms. Preparations showing a release of the active substance(s) which is not deliberately modified by a special formulation design and/or manufacturing method. In the case of a solid dosage form, the dissolution profile of the active substance depends essentially on its intrinsic properties.

(IEEE) Pertaining to a interactive system or mode of operation in which the interaction between the user and the system resembles a human dialog.

Any original data that has been entered into a user-developed application (spreadsheet, database, report, etc.) for manipulation, evaluation, or review.

A condition in which the surface of a welded joint is extended relative to the surface of the tube or pipe. Convexity is measured as a maximum distance from the outside or inside diameter surface of a welded joint along a line perpendicular to a line joining the weld toes.

Any temperature between 8º and 15ºC (46º and 59ºF) is cool. An article for which storage in a cool place is directed may, alternatively, be stored and distributed in a refrigerator, unless otherwise specified by the individual monograph.