Glossary

Blood Establishment Registration and Product Listing (CBER)

A system produced for a customer, specifically to order, to meet a defined set of user requirements. Also called Custom Built System.

Biomonitoring of Environmental Status and Trends Program (United States Geological Survey)

Bacterial Endotoxins Test

Acceptance testing performed by the customer in a live application of the software, at one or more end user sites, in an environment not controlled by the developer.

For medical device software such use may require an Investigational Device Exemption (IDE) or Institutional Review Board (IRB) approval.

Penicillins, cephalosporins, monobactams, and carbapenems. Other APIs containing beta-lactam rings; beta-lactamase inhibitors,clavulanic acid, and sulbactam and tazobactam; typically with sensitization potential.

Bovine Enterovirus

Vaculovirus Expression Vector System

Biologics Field Advisory Committee (CBER)

Bureau of Food & Drug Administration (Philippines)

Bundesinstitut fur Arzneimittel und Medizinprodukte (German Ministry of Health)

Blow/Fill/Seal processing

Institute für Arzneimittel des Bundergesungdheitsamtes (German Health Authority)

Budesgesundheitsamt (German Federal Health Office)

Bovine Growth Hormone

Buffalo Green Monkey

British Generic Manufacturer’s Association

Baby Hamster Kidney cells

Bureau of Health Professionals (HRSA)

Trafic pattern such that materials and personnel may enter and leave through an area.

Bureau of Indian Affairs (United States Department of the Interior)

Brick Institute of America

A measure of how closely the mean value in a series of replicate measurements approaches the true value.