SUPAC
•SCALE UP AND POST
APPROVAL CHANGES

• What are SUPAC documents
• Key SUPAC documents for quality assessment
(FPPs)
• Basic uses of SUPAC documents
• Introduction to SUPAC IR guidance
► Main document
► Equipment addendum
• Examples

QUALITY ASSESSMENT
Manufacturing sciences
Pharmaceutical engineering/pharmaceutical technology
(production methods and systems, facilities, equipment,
etc.)
Pharmaceutical sciences
Chemistry (organic, inorganic, physical, biochemical,
analytical
(e.g. methodology, validation, spectral analysis))
Pharmaceutical chemistry (study of drug design)
Pharmaceutics (study of drug formulation)
Pharmacognosy (study of drugs of natural origin)
Other fields: Math/statistics, microbiology, GMP

A series of documents issued by US FDA (CDER) to
help applicants with post-approval changes
• Documents are categorized into IR, MR and SS
(FPPs)
• Various types of changes are described:
►Components and composition
► Manufacturing (equipment, process)
► Batch size
► Manufacturing site changes

• SUPAC IR (immediate release)
• SUPAC MR (modified release)
• SUPAC IR/MR equipment addendum
• SUPAC IR Q&A
• SS: Non sterile semi-solids + equipment
addendum

Determining the importance of various changes:
SU: scale-up during original dossier assessment
Consider changes made after the biobatch
► Components and composition
► Manufacturing (equipment, process)
► Batch size
► Manufacturing site changes