Glossary

Total Dissolved Solids

Temperature (sensing) Element

A partnership between FDA’s Office of Regulatory Affairs (ORA) and CBER to focus on inspectional and compliance issues in biologics. Its goal is to ensure the quality and safety of biologic products and resolve inconsistencies.

Thermoplastic Elastomer, Chlorinated Ethylene Alloy

Typical agreement with contract vendors that contain roles and responsibilities, service level agreements, processing times, delegation of authority and are co-signed by operations and quality from sponsor and the contract vendor.

A Quality Contract/Quality Agreement/ Technical Agreement is a legal document that establishes a clear definition of cGMP compliance responsibilities between the contract giver and contract acceptor.

The owner of the IS/IT infrastructure and platform for the archive.

Defined approach outlining the use of technology within a project.

The systematic procedure that is followed in order to pass the documented knowledge and experience gained during development and/or commercialization to an appropriate, responsible, and authorized party. Technology transfer embodies both the transfer of documentation and the demonstrated ability of a Receiving Unit to effectively perform the critical elements of transferred technology, to the satisfaction of all parties and any, or all, applicable regulatory bodies.

The process of providing the private sector access to technological advances developed by scientists in basic research institutions, such as universities and government laboratories.

The assembly of data and information as identified by predefined acceptance criteria and provided as a documentation package, which is prepared and passed from the involved departments of the Sending Unit responsible for product, process, or method development to a specified Receiving Unit. The ultimate sign-off of the technology transfer documentation by Development Units, Sending Units, and Receiving Units signifies mutual agreement among all involved parties that the process and test methodology have been developed and demonstrated as satisfying predefined acceptance criteria.

Thermoplastic Elastomer, Ether-Ester

The devices and functions relating to transmission of data between the central processing system and remotely located users.

An enzyme that adds telomeric sequences to the ends of eukaryotic chromosomes.

The end of a chromosome. This specialized structure is involved in the replication and stability of linear DNA molecules.

Tubular Exchanger Manufacturers Association

A specific degree of heat intensity. There are three temperature designations associated with psychrometrics:1.Dry Bulb (DB) – The air temperature as measured by a standard thermometer.2.Wet Bulb (WB) – The air temperature measured by a thermometer with its reservoir bulb wrapped in a moistened cloth wick and exposed to an air stream moving at a velocity of 1,000 feet per minute.3.Dewpoint temperature (DP) – Also called Saturation Temperature is the temperature at which condensation of moisture begins (air is holding 100% of the moisture it can) when the air is cooled, measured in °F.

Freezer-10°C to -20°CCold<8°CRefrigerator2°C to 8°CCool8°C to 15°CControlled Room Temperature20°C to 25°CWarm30°C to 40°CExcessive>40°C

An RNA or single-stranded DNA molecule upon which a complementary nucleotide strand is synthesized. A pattern or mold. DNA stores coded information and acts as a model or template from which information is copied into complementary strands of DNA or transcribed into mRNA.

Separation of products or process ingredients such that two materials do not exist in the same space at the same time.

Separation of products or process ingredients such that two materials do not exist in the same space at the same time.

Response from a supplier to provide the services or goods defined in the proposal.

Thermoplastic Elastomer, Olefinic

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