Glossary Terms (Simple List)
-
In-Use
In the hands of the end user who can be the health professional or the patient. In-Use refers to the time period where product is in the custody of the end user or health care professional. (TR53)
-
In-Use Testing (also called In-Situ Testing)
A field study that validates the effectiveness of a disinfecting agent, the trained operators, and the approved operating procedures. (TR70)
-
Invalid Result
Laboratory test result confirmed to be invalid as determined by a laboratory investigation. (TR88)
-
Invalid Test
Laboratory test that, as a result of the laboratory (Phase I) investigation, did not meet the test method requirements and whose results would not be deemed valid. This may also apply to a test which was aborted (e.g. breakdown of isolator during sterility testing). (TR88)
-
Investigational Medicinal Product
A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial. (TR29)
-
Investigator
A clinician scientist taking part in a clinical trial having direct and immediate clinical responsibility for the subject or patient and their treatment with the clinical trial material. (TR63)
-
In-vitro Transcribed RNA
A RNA copy synthesized using a double-stranded DNA as template. The RNA polymerases of bacteriophage T7 or SP6 are usually used to perform the in-vitro transcription. (TR50)
-
Irradiation
The process by which an item is exposed to ionizing radiation (typically gamma) to reduce or eliminate bioburden. (TR41)
-
ISO 5
Environmental operating conditions defined in ISO 14644-1, “Cleanrooms and associated controlled environments”. (Note: For total particulates, ISO 5 approximates the Class 100 description from the now obsolete U.S. Federal Standard 2009 and is roughly comparable to Grade A as defined in European GMP Annex 1 – “Manufacture of Sterile Medicinal Products.”) (TR22) (TR62)
-
ISO 7
Environmental operating conditions defined in ISO 14644-1, “Cleanrooms and associated controlled environments.” Note: For total particulates, ISO 7 approximates Class 10,000 from the now obsolete Federal Standard 209. (TR62)