Automated or non-automated, mechanical or non-mechanical equipment used to
produce the drug product, including equipment used to package the drug product.
A listing of ingredients and composition of the dosage form.
Reports containing scientific data and expert professional judgment to substantiate
SUPAC Guidelines and Platform Technology 27
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)].
Rules or concepts governing the operation of the system.
The manufacture of either drug substance or drug product by a procedure fully
representative of and simulating that used for full manufacturing scale.
A series of operations and/or actions used to produce a desired result.
The extent to which or the limits between which acceptable variation exists.
Agreeing in kind, amount; unchanged in character or condition.
The process of increasing the batch size.
The process of decreasing the batch size.
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.
Establishing through documented evidence a high degree of assurance that a
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