F. Equipment

Automated or non-automated, mechanical or non-mechanical equipment used to

produce the drug product, including equipment used to package the drug product.

G. Formulation

A listing of ingredients and composition of the dosage form.

H. Justification

Reports containing scientific data and expert professional judgment to substantiate

decisions.

SUPAC Guidelines and Platform Technology 27

I. New drug substance

Any substance that, when used in the manufacture, processing, or packing of a drug,

causes that drug to be a new drug, but does not include intermediates used in the

synthesis of such substance [21 CFR 310.3(g)].

J. Operating principle

Rules or concepts governing the operation of the system.

K. Pilot-scale

The manufacture of either drug substance or drug product by a procedure fully

representative of and simulating that used for full manufacturing scale.

L. Process

A series of operations and/or actions used to produce a desired result.

M. Ranges

The extent to which or the limits between which acceptable variation exists.

N. Same

Agreeing in kind, amount; unchanged in character or condition.

O. Scale-up

The process of increasing the batch size.

P. Scale-down

The process of decreasing the batch size.

Q. Similar

Having a general likeness.

R. A significant body of information

A significant body of information on the stability of the drug product is likely to exist

after five years of commercial experience for new molecular entities, or three years of

commercial experience for new dosage forms.

S. Validation

Establishing through documented evidence a high degree of assurance that a