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.
The documented verification that the facilities, systems and equipment, as installed or modified, comply with the approved design and the manufacturer’s recommendations.
The international body responsible for harmonising worldwide regulatory requirements for pharmaceuticals.
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.
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.
International Standards Organization.