SCALE-UP AND POST-APPROVAL CHANGES (SUPAC)

SCALE-UP AND POST-APPROVAL CHANGES (SUPAC)

The term "SUPAC" refers to the scale-up procedure as well as changes made to the composition, manufacturing procedure, manufacturing equipment, and change of location after approval.

During the post-approval period, pharmaceutical sponsors of new drug applications (NDAs), abbreviated new drug applications (ANDAs), and abbreviated antibiotic drug applications (AADAs) who intend to change a semisolid formulation's components or composition, manufacturing (process and equipment), scale-up/scale-down of manufacturing, and/or the site of manufacture may use the recommendations provided in this guidance.

This advice covers topical modes of administration for non-sterile semisolid preparations (such as creams, gels, lotions, and ointments).

The recommendations outline the levels of change, the recommended in vitro release tests and/or in vivo bioequivalence testing to support each level of change, (3) recommended CMC tests to support each level of change, and (4) documentation to support the change.

In order to maintain product quality and performance characteristics of the semisolid topical formulation for specified alterations, the Center for Drug Evaluation and Research (CDER) must be given with the application information indicated in the advice.

Neither the Office of Compliance in CDER nor the Office of Regulatory Affairs at FDA make any comments about or otherwise have an impact on compliance/inspection documentation.

Semisolid dose forms typically have complex formulations with complex structural components.

which are made up of two phases—oil and water—of which the internal phase is scattered and the external phase is continuous.

Although the medicine is not completely soluble in the system and is dispersed in one or both phases, generating a three-phase system, the active ingredient is frequently dissolved in one phase.

The size of the dispersed particles, the interfacial tension between the phases, the partition coefficient of the active ingredient between the phases, and the product rheology are all variables that affect the physical properties of the dosage form.

These elements work together to influence the drug's release properties as well as other properties including viscosity.

SUPAC changes designated as:

SUPAC-IR: for immediate release solid oral dosage form

SUPAC-MR: for modified release solid oral dosage form

SUPAC-SS: for non-sterile semisolid dosage form including creams, ointments, gels and lotions.

SUPAC-SS components and composition

Level

Classification

Test documentation

Filing documentation

1

-Dilation or partial dilation of an ingredient.

-Change in supplier or technical grade of any other excipient.

-Up to 5% change in approved amount of ingredient.

-Stability

 

 

Application/compendial requirements

Annual report

 

 

 

 

 

 

 

 

2

-Change in particle size distribution of the drug substance

-Change in supplier or technical grade of any other excipient.

Invitro release test

Annual report

3

Change in approved amount of ingredient

Stability

Prior approval supplement

SUPAC-SS PRESERVATIVE

Level

Classification

Test documentation

Filing documentation

1

Quantitatively 10% or less change in the approved amount of preservative

Application/ compendial requirements

Annual report

2

10%-20% change in the approved amount of preservative

Application/compendial requirements

Annual report

3

20% change in the approved amount of preservative

Application/compendial requirements executed batch records

Annual report


Limitation of SUPAC

SUPAC has not been updated

Does not discuss multiple changes

Does not cover modified equipment


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