Supac

Guidance for Industry
SUPAC-IR/MR: Immediate Release and
Modified Release Solid Oral Dosage Forms
Manufacturing Equipment Addendum

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
January 1999
CMC 9
Revision 1

Guidance for Industry
SUPAC-IR/MR: Immediate Release and
Modified Release Solid Oral Dosage FormsManufacturing Equipment Addendum
Additional copies are available from:
Office of Training and Communications
Division of Communications Management
Drug Information Branch, HFD-210
5600 Fishers Lane
Rockville, MD 20857
(Tel) 301-827-4573
(Internet) http://www.fda.gov/cder/guidance/index.htm

U.S. Department of Health and Human Services
Food and Drug Administration
Center for DrugEvaluation and Research (CDER)
January 1999
CMC 9
Revision 1

TABLE OF CONTENTS

I.

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

II.

PARTICLE SIZE REDUCTION/SEPARATION . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

III.

BLENDING AND MIXING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . 9

IV.

GRANULATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

V.

DRYING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

VI.

UNIT DOSING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . 26

VII.

SOFT GELATIN CAPSULES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

VIII. COATING/PRINTING/DRILLING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

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GUIDANCE FOR INDUSTRY 1
SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage
Forms Manufacturing Equipment AddendumI.

INTRODUCTION

The purpose of this guidance is to provide recommendations to pharmaceutical manufacturers
using the Center for Drug Evaluation and Research's Guidance for Industry: Immediate Release
Solid Oral Dosage Forms — Scale-Up and Post-Approval Changes: Chemistry, Manufacturing
and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation
(SUPAC-IR), whichpublished in November 1995, and Guidance for Industry: SUPAC-MR:
Modified Release Solid Oral Dosage Forms Scale-Up and Post-Approval Changes: Chemistry,
Manufacturing and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence
Documentation, which published in October 1997. This document was developed by the U.S.
Food and Drug Administration (FDA) with the assistance of theInternational Society of
Pharmaceutical Engineering (ISPE). This document extends and supersedes the Manufacturing
Equipment Addendum published in October 1997 that covered only immediate release solid oral
dosage forms. The scope of this document is limited to only changes of equipment. If changes in
components and composition, site, scale, or process occur in addition to the equipment change,
thenthis should be considered a multiple change under SUPAC-IR and SUPAC-MR. For
modified release solid oral dosage forms, consideration should be given as to whether or not the
change in manufacturing equipment is critical to drug release (critical equipment variable).
The document should be used in conjunction with the SUPAC-IR and SUPAC-MR guidance
documents in determining what documentationshould be submitted to FDA regarding equipment
changes made in accordance with the recommendations in these guidance documents. The
SUPAC guidance documents define (1) levels of change; (2) recommended chemistry,
manufacturing, and controls tests for each level of change; (3) in vitro dissolution tests and/or in
vivo bioequivalence tests for each level of change; and (4) documentation that...