Glossary: i
In Process Control
Checks performed during production in order to monitor and if necessary to adjust the process to ensure that the product conforms its specification. The control of the environment or equipment may also be regarded as a part of in-process control.
Installation Qualification (IQ)
The documented verification that the facilities, systems and equipment, as installed or modified, comply with the approved design and the manufacturer’s recommendations.
International Committee on Harmonisation
The international body responsible for harmonising worldwide regulatory requirements for pharmaceuticals.
Investigational Medicinal Product
A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form.
Investigational Medicinal Product Dossier
The Investigational Medicinal Product Dossier is the basis for approval of clinical trials by the competent authorities in the EU. The IMPD includes summaries of information related to the quality, manufacture and control of the Investigational Medicinal Product, data from non-clinical studies and from its clinical use.
ISO
International Standards Organization.
