Tamper Evident

Describes a means to reveal any interference with the integrity of the finished packaged excipient and designed to make improper opening of an excipient?s packaging evident to the purchaser.


The occurrence of structural malformations in a developing fetus when a substance is administered during pregnancy. [16]

Therapeutic Equivalence

Two pharmaceutical products are considered to be therapeutically equivalent if they are pharmaceutically equivalent or pharmaceutical alternatives and after administration in the same molar dose, their effects, with respect to both efficacy and safety, are essentially the same when administered to patients by the same route under the conditions specified in the labeling. This can be demonstrated by appropriate bioequivalence studies, such as pharmacokinetic, pharmacodynamic, clinical or in vitro studies. [24]

Top Management

A person or group of people who direct and control an organization at the highest level. The highest level may either be at the site or corporate level and will depend on how the quality management system is organized.


Ability to determine the history, application or location that is under consideration, for example, origin of materials and parts, processing history or distribution of the product after delivery. [1, 3]

Trader / Trading

See Broker/Broking. [3]


The period during which pharmaceutical products are in the process of being carried, conveyed, or transported across, over or through a passage or route to reach the destination. [17]

Transmissible Spongiform Encephalopathy (TSE)

TSE's are rare forms of progressive neurodegenerative disorders that affect both humans and animals and are caused by similar uncharacterized agents that generally produce spongiform changes in the brain. Specific examples of TSE's include: scrapie, which affects sheep and goats; BSE, which affects cattle; transmissible mink encephalopathy; feline spongiform encephalopathy; chronic wasting disease (CWD) of mule deer, white-tailed deer, black-tailed deer, and elk; and in humans, kuru, Creutzfeldt-Jakob disease, Gerstmann-Straussler syndrome, fatal familial insomnia, and variant Creutzfeldt-Jakob disease (vCJD). [6]


The term transparency means:

  • defining policies and procedures in writing and publishing the written documentation; and
  • giving reasons for decisions to the public (see also accountability above). [25]


A statistical term referring to the direction or rate of change of a variable. [10]


Transmissible Spongiform Encephalopathy

Typical Usage Level

The quantity of excipient expected to be found in drug products based upon excipient functionality. [7]