Pharm Vocab

Any component that is intended to furnish pharmacologic activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure or function of the body of man or other animals.

A specific quantity of a drug of uniform specified quality produced according to a single manufacturing order during the same cycle of manufacture.

The use of validated in-process sampling and testing methods in such a way that results prove the process has done what it purports to do for the specific batch concerned.

Documented testimony by qualified authorities that a system qualification, calibration, validation, or relavidation has been performed appropriately and that the results are acceptable.

Determination through inspection of the extent to which a manufacturer is acting in accordance with prescribed regulations, standards, and practices.

Any ingredient used in the manufacture of a drug product, including those that may not be present in the finished product.

A finished form that contains an active drug and inactivee ingredients. This term may also include a form that does not contain an active ingredient, such as a placebo.

Any component other than the active ingredients in a drug product.

A batch or any portion of a batch having uniform specified quality and a distinctive identifying lot number.

Any distinctive combination of letters, numbers, or symbols, from which the compplete history of the manufacture, processing, packaging, holding, and distribution of a batch or lot of a drug product may be determined.

Record containting the formulation, specifications, manufacturing procedures, quality assurance requirements, and labeling of a finished product.

Provision to all concerned the evidence needed to establish confidence that the activities relating to quality are being performed adequately.

A documented activity performed in accordance with established procedures on a planned and periodic basis to verify compliance with the procedures to ensure quality.

The regulatory process through which industry measures actual quality performance, compares it with standards, and acts on the difference.

An organizational element designed by a firm to be responsible for the duties relating to quality control.

An area that is marked, designated, or set aside for the holding of incoming components prior to acceptance testing and qualification for use.

A sample that accurately portrays the whole.

The aactivity whereby the finished product or any of its components is recycled through all or part of the manufacutring process.

The concentration of the drug substance per unit dose or volume.

Signed by a second individual or recorded by automated equipment.

Documented evidence that a system (equipment, software, controls) does what it purports to do.