26 Industrial Pharmacy II

iii. The drug categorization research conducted at the University of Michigan and

the University of Uppsala on the permeability of drug substances; and

iv. The Scale-up and Post Approval Changes (SUPAC) Task Force established by

the Centre for Drug Evaluation and Research (CDER) Chemistry, Manufacturing

and Controls Coordinating Committee to develop guidance on scale-up and other

post-approval changes.

3.3 TERMINOLOGIES USED IN GUIDANCE DOCUMENT

A. Batch

A specific quantity of a drug or other material produced according to a single

manufacturing order during the same cycle of manufacture and intended to have

uniform character and quality, within specified limits [21 CFR 210.3(b)(2)].

B. Contiguous campus

Continuous or unbroken site or a set of buildings in adjacent city blocks.

C. Dissolution testing

Case A Dissolution of Q = 85% in 15 minutes in 900 millilitres (mL) of 0.1 N

hydrochloride (HCl), using the United States Pharmacopeia (USP) <711> Apparatus 1

at 100 revolutions per minute (rpm) or Apparatus 2 at 50 rpm.

Case B Multi-point dissolution profile in the application/compendial medium at

15, 30, 45, 60, and 120 minutes or until an asymptote is reached for the proposed and

currently accepted formulation.

Case C Multi-point dissolution profiles performed in water, 0.1 N HCl, and USP

buffer media at pH 4.5, 6.5, and 7.5 (five separate profiles) for the proposed and

currently accepted formulations. Adequate sampling should be performed at 15, 30,

45, 60, and 120 minutes until either 90% of the drug from the drug product is dissolved

or an asymptote is reached. A surfactant may be used with appropriate justification.

D. Drug product

A drug product is a finished dosage form (e.g. tablet, capsule, or solution) that contains

a drug substance, generally, but not necessarily, in association with one or more other

ingredients [21 CFR 314.3(b)]. A solid oral dosage form includes tablets, chewable

tablets, capsules, and soft gelatine capsules.

E. Drug substance

An active ingredient that is intended to furnish pharmacological activity or other direct

effect in the diagnosis, cure, mitigation, treatment, or prevention of a disease, or to

affect the structure of any function of the human body, but does not include

intermediates used in the synthesis of such ingredient [21 CFR 314.3(b)].