Glossary

Computerized technology which combines the use of databases and telephones to input, retrieve and manage information.

Computerized technology which combines the use of databases and the Internet to input, retrieve and manage information.

(ICH Q4B) Where such status is indicated, any of the official texts from JP, EP, or USP can be substituted one for the other (appropriately referenced) in the ICH regions for purposes of the pharmaceutical registration/approval process. Using any of the interchangeable methods, an analyst will reach the same accept or reject decisions irrespective of which PDG pharmacopeia is used.

(ISO) A shared boundary between two functional units, defined by functional characteristics, common physical interconnection characteristics, signal characteristics, and other characteristics, as appropriate. The concept involves the specification of the connection of two devices having different functions.

(FDA) A point of communication between two or more processes, persons, or other physical entities.

Peripheral device which permits two or more devices to communicate.

(ANSI/IEEE) A shared boundary. To interact or communicate with another system component.

(IEEE) Evaluation of:1.Software requirements specifications with hardware, user, operator, and software interface requirements documentation.2.Software design description records with hardware, operator, and software interface requirements specifications.3.Source code with hardware, operator, and software interface design documentation, for correctness, consistency, completeness, accuracy, and readability. Entities to evaluate include data items and control items.

(IEEE) A requirement that specifies an external item with which a system or system component must interact, or sets forth constraints on formats, timing, or other factors caused by such an interaction.

(NIST) A specification that documents the interface requirements for a system or system component. Often part of a requirements specification.

(IEEE) Testing conducted to evaluate whether systems or components pass data and control correctly to one another.

Crossing over at one point that alters the chance of another crossing-over nearby; detected by studying the pattern of crossings-over with three or more linked genes. Interference is positive or negative depending on whether the chance of another crossing-over nearby is reduced or increased, respectively.

A glycoprotein made by animal cells that is involved in immunoregulation and fighting viral infections by preventing virus multiplication in cell.

A class of glycoproteins produced by the body in response to a viral infection – inhibits virus reproduction.

Intergranular corrosion is a form of relatively rapid and localized corrosion associated with a defective microstructure known as carbide precipitation. When austenitic steels have been exposed to high temperatures and allowed to cool at a relatively slow rate such as occurs after welding, the chromium and carbon in the steel combine to form chromium carbide particles along the grain boundaries; the formation of these carbide particles depletes the surrounding metal of chromium and reduces its corrosion resistance, allowing preferential corrosion along the grain boundaries. Steel in this condition is referred to as “sensitized”.

A type of lymphokine that regulates the growth and development of white blood cells. Twelve interleukins (1L-1 through 1L-12) have been identified to date.

In water monitoring systems – Compared to Phase 2 of the ISPE C&Q GPG, this sampling phase further demonstrates consistent production and delivery of water of the required quality within the established ranges, when using SOP’s. It also may provide additional worst case data since use points are not as frequently active. Its duration may be between 10 and 20 days.(also see: Initial, Extended Sampling)

(ICH Q5C) For biotechnological/biological products, a material produced during a manufacturing process which is not the drug substance or the drug product but whose manufacture is critical to the successful production of the drug substance or the drug product. Generally, an intermediate will be quantifiable and specifications will be established to determine the successful completion of the manufacturing step prior to continuation of the manufacturing process. This includes material which may undergo further molecular modification or be held for an extended period of time prior to further processing.

(ICH Q3A (R2))A material produced during steps of the synthesis of a new drug substance that undergoes further chemical transformation before it becomes a new drug substance.

(ICH Q7) A material produced during steps of the processing of an API that undergoes further molecular change or purification before it becomes an API. Intermediates may or may not be isolated.(NOTE: ICH Q7 only addresses those intermediates produced after the point that the company has defined as the point at which the production of the API begins.)

Especially in chemical drug manufacturing, a drug compound that has not reached the state of final bulk product.

Contact with a substance that occurs for more than 14 days and less than a year.

(ICH Q2 (R1)) Intermediate precision expresses within-laboratories variations: different days, different analysts, different equipment, etc.

(ICH Q1A (R2)) Studies conducted at 30°C/65% RH and designed to moderately increase the rate of chemical degradation or physical changes for a drug substance or drug product intended to be stored long term at 25°C.

The International Association for Food Protection [formerly known as International Association of Milk, Food, and Environmental Sanitarians (IAMFES)], founded in 1911, is a non-profit association of food safety professionals. The Association is dedicated to providing education in food protection and public health to its members, as well as individuals working in all areas of, industry, government, and academia. Through the Association, Members are able to keep informed of the latest scientific, technical, and practical developments in food safety and sanitation. The Association provides it’s Members with an information network through its two scientific journals, Food Protection Trends and Journal of Food Protection®, its educational Annual Meeting, and interaction with other food safety professionals.