B
Backup

A local or remote copy of computer files for the purpose of restoring the data in the event of a mishap.

Barrier Packaging Materials

Either primary or secondary packaging materials which also have the function of preventing the permeation of gases, moisture or volatile concomitant components into or from the excipient.

NOTE: Shipping pallets are not considered secondary packaging.

Batch (Lot)

A specific quantity of material produced in a process or series of processes so that it can be expected to be homogeneous. In the case of continuous processes, a batch may correspond to a defined fraction of the production. The batch size can be defined either by a fixed quantity or by the amount produced in a fixed time interval. [6]

Batch Number (Lot Number)

A unique combination of numbers, letters and/or symbols that identifies a batch and from which the production and distribution history can be determined. [1, 2, 3]

Batch Process

A manufacturing process or processing step that produces the excipient from a discrete supply of raw material that is present before the completion of the reaction. [1, 3]

Batch Processing

A manufacturing process or processing step that produces the excipient from a discrete supply of raw material that is present before the completion of the reaction. [1, 3]

Batch Record

Documentation that provides a history of the manufacture of a batch of excipient. [1]

Batch/Lot

A specific quantity of material produced in a process or series of processes so that it can be expected to be homogeneous. In the case of continuous processes, a batch may correspond to a defined fraction of the production. The batch size can be defined either by a fixed quantity or by the amount produced in a fixed time interval. [6]

Bill of Lading

A document used when shipping goods that describes the content of the shipment and accompanies it. [4]

Bioavailability

The rate and extent at which the active pharmaceutical ingredient or active moiety is absorbed from a pharmaceutical dosage form and becomes available at the site(s) of action. [25]

Bioburden

The level and type (e.g. objectionable or not) of micro-organisms that can be present in raw materials, starting materials, excipients, intermediates or APIs. Bioburden should not be considered contamination unless the levels have beenexceeded or defined objectionable organisms have been detected. [2]

Bioequivalence

Two pharmaceutical products are bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives, and their bioavailabilities, in terms of peak (Cmax and Tmax) and total exposure (area under the curve (AUC)) after administration of the same molar dose under the same conditions, are similar to such a degree that their effects can be expected to be essentially the same. [24, 25]

Biological Origin

Any substance produced from animal or vegetable materials including starting materials and processing materials where the latter can come into contact with the excipient.

Biotechnology Derived Excipients

Applies to excipients derived from characterized cells through the use of a variety of expression systems including but not limited to bacteria, yeast, insect, plant, and mammalian cells. [7]

Bioterrorism Act

The United States Public Health Security and Bioterrorism Preparedness and Response Act of 2002. [6]

Bovine Spongiform Encephalopathy (BSE)

A slowly progressive, degenerative, fatal disease affecting the central nervous system of adult cattle. The exact cause of BSE is not known but it is generally accepted by the scientific community that the likely cause is infectious forms of a type of protein, prions, normally found in animals cause BSE. In cattle with BSE, these abnormal prions initially occur in the small intestines and tonsils, and are found in central nervous tissues, such as the brain and spinal cord, and other tissues of infected animals experiencing later stages of the disease. There is a disease similar to BSE called Creutzfeldt-Jacob Disease (CJD) that is found in people. A variant form of CJD (vCJD) is believed to be caused by eating contaminated beef products from BSE-affected cattle. [6]

BP

British Pharmacopoeia

Bracketing

The design of a stability schedule such that only samples on the extremes of certain design factors, e.g., strength, package size, are tested at all time points as in a full design. The design assumes that the stability of any intermediate levels is represented by the stability of the extremes tested. Where a range of strengths is to be tested, bracketing is applicable if the strengths are identical or very closely related in composition (e.g., for a tablet range made with different compression weights of a similar basic granulation, or a capsule range made by filling different plug fill weights of the same basic composition into different size capsule shells). Bracketing can be applied to different container sizes or different fills in the same container closure system. [13]

BRC

British Retail Consortium

Broker / Broking

Brokers resell excipients without conducting physical handling of the product such as warehousing, transport, repackaging etc. [3]

Bulk excipient

Excipient in any transportation or storage equipment (tanks, silos, ISO-Containers, tank/silo trucks etc.) to be filled/repackaged into others (tanks, silos, drums, bags, containers etc.). [3]

Bulk Pharmaceutical Excipient (BPE)

Excipient in any transportation or storage equipment (tanks, silos, ISO-Containers, tank/silo trucks etc.) to be filled/repackaged into others (tanks, silos, drums, bags, containers etc.). [3]

Bulk product

Any product that has completed all processing stages up to, but not including, final packaging. [20]