T
Tank
Static thermally insulated container designed for the storage of liquefied or cryogenic gas. They are also called “Fixed cryogenic vessels”. [EU GMP Guide, Annex 6]
Tanker
In the context of the Annex, thermally insulated container fixed on a vehicle for the transport of liquefied or cryogenic gas. [EU GMP Guide, Annex 6]
Target Material
A chemical substance which is bombarded with nuclear particles to produce a desired radionuclide. [Canadian GMP Guidelines, Annex 5]
Technology Transfer Report
A documented summary of a specific technology transfer project listing procedures, acceptance criteria, results achieved and conclusions. Any deviation should be discussed and justified. [TRS 961 Annex 7, WHO]
Temperatur-controlled
Includes any environment in which the temperature is actively or passively controlled at a level different from that of the surrounding environment within precise predefined limits. [TRS 961 Annex 9, WHO]
Temperature-modified
Includes any environment in which the temperature is predictably maintained at a level different from that of the surrounding environment, but is not actively or passively controlled within precise predefined limits. [TRS 961 Annex 9, WHO]
Teratogenicity
The occurrence of structural malformations in a developing fetus when a substance is administered during pregnancy. [ICH Q3C]
Terminal Sterilization
The application of a lethal agent to sealed, finished drug products for the purpose of achieving a predetermined sterility assurance level (SAL) of usually less than 10-6 (i.e., a probability of a nonsterile unit of greater than one in a million). [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Sterilizing a drug in its final closed container. [Canadian GMP Guidelines 2009]
Therapeutic Activity
Therapeutic activity refers to the successful prevention, diagnosis and treatment of physical and mental illnesses, improvement of symptoms of illnesses, as well as beneficial alteration or regulation of the physical and mental status of the body and development of a sense of general well-being. [Specific Pharmaceutical Products, WHO]
Time- and Temperature-sensitive Pharmaceutical Product (TTSPP)
Any pharmaceutical good or product which, when not stored or transported within predefined environmental conditions and/or within predefined time limits, is degraded to the extent that it no longer performs as originally intended. [TRS 961 Annex 9, WHO]
Tissue Engineered Product (TEP)
A product that
Total Containment Glove Box
An aseptic suite of totally enclosed environment at negative pressure, whose primary purpose is to maintain a sterile environment with the additional purpose of radioactivity workspace localization. [Canadian GMP Guidelines, Annex 3]
Total Organic Carbon (TOC)
A nonspecific analytical procedure that involves oxidizing the residue to carbon dioxide, and then measuring the generated carbon dioxide.
Total Radioactivity
Amount of radioactivity present in the total volume of a reconstituted preparation or total volume of an eluate or solution used for reconstitution/labelling purposes, expressed as mCi/total volume (ml) or MBq/total volume (ml). [Canadian GMP Guidelines, Annex 3]
Traceback
The process of investigating a report of a suspected transfusion-associated infection in order to identify a potential implicated donor. The purpose of the investigation is to determine whether any donor who contributed to the transfusion is infected with, or positive for, serologic markers of the same infectious agent, and to retrieve available blood components from that donor, and to notify consignees and recipients of components collected from the same donor. [Canadian GMP Guidelines, Annex 14]
Traditional Approach
A product development approach where set points and operating ranges for process parameters are defined to ensure reproducibility. [EU GMP Guide, Annex 15, Guideline on Process Validation for Finished Products, EMA]
Transfer Device
A fixed or removable device, which allows material to be transferred into and out of a container or a pharmaceutical isolator, without exposing it to the external environment. [PIC/S PE 010-4]
Transgenic
An organism that contains a foreign gene in its normal genetic component for the expression of biological pharmaceutical materials. [EU GMP Guide, Annex 2]
Transit
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. [Good Distribution Practices for Pharmaceutical Products, WHO]
Transport
Moving medicinal products between two locations without storing them for unjustified periods of time. [EU GDP Guidelines]
Trend
A statistical term referring to the direction or rate of change of a variable(s). [ICH Q9]
TTSPP
see Time- and Temperature- sensitive Pharmaceutical Product
Turbulent Flow
Turbulent flow, or non-unidirectional airflow, is air distribution that is introduced into the controlled space and then mixes with room air by means of induction. [Main Principles for Pharmaceutical Products, WHO]
Static thermally insulated container designed for the storage of liquefied or cryogenic gas. They are also called “Fixed cryogenic vessels”. [EU GMP Guide, Annex 6]
Tanker
In the context of the Annex, thermally insulated container fixed on a vehicle for the transport of liquefied or cryogenic gas. [EU GMP Guide, Annex 6]
Target Material
A chemical substance which is bombarded with nuclear particles to produce a desired radionuclide. [Canadian GMP Guidelines, Annex 5]
Technology Transfer Report
A documented summary of a specific technology transfer project listing procedures, acceptance criteria, results achieved and conclusions. Any deviation should be discussed and justified. [TRS 961 Annex 7, WHO]
Temperatur-controlled
Includes any environment in which the temperature is actively or passively controlled at a level different from that of the surrounding environment within precise predefined limits. [TRS 961 Annex 9, WHO]
Temperature-modified
Includes any environment in which the temperature is predictably maintained at a level different from that of the surrounding environment, but is not actively or passively controlled within precise predefined limits. [TRS 961 Annex 9, WHO]
Teratogenicity
The occurrence of structural malformations in a developing fetus when a substance is administered during pregnancy. [ICH Q3C]
Terminal Sterilization
The application of a lethal agent to sealed, finished drug products for the purpose of achieving a predetermined sterility assurance level (SAL) of usually less than 10-6 (i.e., a probability of a nonsterile unit of greater than one in a million). [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Sterilizing a drug in its final closed container. [Canadian GMP Guidelines 2009]
Therapeutic Activity
Therapeutic activity refers to the successful prevention, diagnosis and treatment of physical and mental illnesses, improvement of symptoms of illnesses, as well as beneficial alteration or regulation of the physical and mental status of the body and development of a sense of general well-being. [Specific Pharmaceutical Products, WHO]
Time- and Temperature-sensitive Pharmaceutical Product (TTSPP)
Any pharmaceutical good or product which, when not stored or transported within predefined environmental conditions and/or within predefined time limits, is degraded to the extent that it no longer performs as originally intended. [TRS 961 Annex 9, WHO]
Tissue Engineered Product (TEP)
A product that
- Contains or consists of engineered cells or tissues, and
- Is presented a having properties for, or ist used in or administered to human beings with a view to regenerating, repairing or replacing a human tissue
Total Containment Glove Box
An aseptic suite of totally enclosed environment at negative pressure, whose primary purpose is to maintain a sterile environment with the additional purpose of radioactivity workspace localization. [Canadian GMP Guidelines, Annex 3]
Total Organic Carbon (TOC)
A nonspecific analytical procedure that involves oxidizing the residue to carbon dioxide, and then measuring the generated carbon dioxide.
Total Radioactivity
Amount of radioactivity present in the total volume of a reconstituted preparation or total volume of an eluate or solution used for reconstitution/labelling purposes, expressed as mCi/total volume (ml) or MBq/total volume (ml). [Canadian GMP Guidelines, Annex 3]
Traceback
The process of investigating a report of a suspected transfusion-associated infection in order to identify a potential implicated donor. The purpose of the investigation is to determine whether any donor who contributed to the transfusion is infected with, or positive for, serologic markers of the same infectious agent, and to retrieve available blood components from that donor, and to notify consignees and recipients of components collected from the same donor. [Canadian GMP Guidelines, Annex 14]
Traditional Approach
A product development approach where set points and operating ranges for process parameters are defined to ensure reproducibility. [EU GMP Guide, Annex 15, Guideline on Process Validation for Finished Products, EMA]
Transfer Device
A fixed or removable device, which allows material to be transferred into and out of a container or a pharmaceutical isolator, without exposing it to the external environment. [PIC/S PE 010-4]
Transgenic
An organism that contains a foreign gene in its normal genetic component for the expression of biological pharmaceutical materials. [EU GMP Guide, Annex 2]
Transit
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. [Good Distribution Practices for Pharmaceutical Products, WHO]
Transport
Moving medicinal products between two locations without storing them for unjustified periods of time. [EU GDP Guidelines]
Trend
A statistical term referring to the direction or rate of change of a variable(s). [ICH Q9]
TTSPP
see Time- and Temperature- sensitive Pharmaceutical Product
Turbulent Flow
Turbulent flow, or non-unidirectional airflow, is air distribution that is introduced into the controlled space and then mixes with room air by means of induction. [Main Principles for Pharmaceutical Products, WHO]