Pharm Definitions

Active ingredient (API)

Any component 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.

Batch

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

Batchwise control

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

Certification

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

Inactive ingredient

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

Lot

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

Lot number

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

Master record

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

Quality assurance

Provision of evidence needed to establish confidence that activities relating to quality are being performed adequately.

Quality audit

A documented activity performed periodically to verify compliance with established procedures to ensure quality.

Quality control

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

Quality control unit

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

Quarantine

An area marked or designated for holding incoming components prior to acceptance testing and qualification for use.

Representative sample

A sample that accurately portrays the whole.

Reprocessing

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

Strength

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

Verified

Signed by a second individual or recorded by automated equipment.

Validation

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

Process validation

Documented evidence that a process (e.g., sterilization) does what it purports to do.

Usual adult dose

Starting dose for a patient.

Usual dosage range

Safety dose range for administering drug product.

Dosage regimen

Schedule of dosage.

Maintenance doses

Maintain clinically relevant drug levels in blood.

Prophylactic dose

Administered to prevent patients from contracting the disease.

Therapeutic dose

Administered once disease has been contracted.

Minimum effective concentration (MEC)

The minimum dose required to get a desired effect.

Minimum toxic concentration (MTC)

Administering drugs above this level will produce dose related toxicities.

Median effective dose (MED)

Dose will produce a desired intensity of a drug effect in 50% of the individuals tested.

Compliance

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

Component

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

Drug product

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

Validation protocol

A prospective experimental plan to produce documented evidence that the system has been validated.