Glossary

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(ICH Q7) An inorganic or organic liquid used as a vehicle for the preparation of solutions or suspensions in the manufacture of an intermediate or API.

A liquid capable of dissolving a solute. A substance, usually a liquid, into which another substance is dissolved.

(ICH Q3A (R2)) An inorganic or an organic liquid used as a vehicle for the preparation of solutions or suspensions in the synthesis of a new drug substance.

(ICH Q6A) An inorganic or an organic liquid used as a vehicle for the preparation of solutions or suspensions in the synthesis of a new drug substance or the manufacture of a new drug product.

In higher organisms, a cell that (unlike germ cells) carries the full genetic make-up of an organism. Any cell in the body except gametes and their precursors.

Somatic cell gene therapy involves the insertion of genes into cells for therapeutic purposes; for example, to induce the treated cells to produce a protein that the body is missing. It does not affect genetic makeup of a patient’s offspring and generally does not change all, or even most, cells in the recipient. Somatic cell gene therapy is only one way of applying the science of genomics to improve health care.

Growth-hormone-releasing hormone.

Growth-hormone-inhibiting hormone.

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Epigenetic or genetic changes, sometimes expressed as a new trait, resulting from in vitro culture of higher plants.

Steam-Out-of-Place

Standard Operating Procedure

Standard Operating Procedures. Instructions that specify how an activity is to be accomplished.

(EMEA – CHMP) Bonding of a solute to a plastic packaging component as a physicochemical phenomenon related to the properties of the packaging material and the chemical properties of the active substance or other soluble substances in the preparation.

The uptake of product components by the plastic materials.(contrast with: Leaching)

An original computer program, either in human-readable or machine-readable form.

(FDA) Computer instructions and data definitions expressed in a form suitable for input to an assembler, compiler or other translator.

(IEEE) The human readable version of the list of instructions (program) that cause a computer to perform a task.

All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).

The DNA from an organism that contains a target gene; this DNA is used as starting material in a cloning experiment.

Original documents, data, and records (e.g. hospital records, clinical and office charts, laboratory notes, memoranda, subject’s diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at the medico-technical departments involved in a clinical trial).

Plasma collected by plasmapheresis (21 CFR640.60), and subject to the licensure provisions of Section 351 of the PHS Act.

(IEEE) A computer program that must be compiled, assembled, or otherwise translated in order to be executed by a computer.