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The batch size of the product under development process at laboratory-scale is very

small. It increases gradually as development process develops. This is known as scaleup. During the scale-up of the product, the product gets market approval from

regulatory authorities. But there may be some changes in the product after the approval.

These are known as SUPAC, i.e. scale-up post-approval changes. These changes are

related to composition, manufacturing process, manufacturing equipment and

manufacturing sites. These changes have to be approved before implementation. So,

to guide the industries regarding SUPAC, USFDA issues various guidance documents

“such as”

i. SUPAC-IR (for immediate release solid oral dosage form)

ii. SUPAC-MR (for modifies release solid oral dosage form)

iii. SUPAC-SS (for non-sterile semi-solid dosage forms)

3.1 PURPOSE OF GUIDANCE

The guidance provides recommendations to sponsors of:

i. New drug applications (NDAs)

ii. Abbreviated new drug applications (ANDAs)

iii. Abbreviated antibiotic applications (AADAs)

During the period after approval to change composition, manufacturing process,

manufacturing equipment, and manufacturing sites.

3.2 EVOLUTION OF SUPAC GUIDANCE

The SUPAC guidance documents are the result of:

i. A workshop on the scale-up of immediate-release drug products conducted by

the American Association of Pharmaceutical Scientists in conjunction with the

United States Pharmacopoeial Convention and the Food and Drug Administration

(FDA);

ii. Research conducted by the University of Maryland at Baltimore on the chemistry,

manufacturing and controls of immediate-release drug products under the FDA/

University of Maryland Manufacturing Research Contract;

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SUPAC Guidelines and Platform

Technology

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