Mukund Chorghade

A

Drug Substance:

• Physical and chemical characteristics
• Elucidation of structure
• Description of synthesis
• In-process controls
• Reference standard
• Stereoisomers
• Container/closure systems
• Labeling

B

Drug Product:

• Qualitative and quantitative composition
• Use of USP vs. International Compendia Requirements
• Description of facility
• Description of the method of manufacture and batch records
• In-process controls – tests and Methods

Mukund Chorghade

C

Analytical Methods, Impurities, Stability:

• Preparing the analytical methods section
• Regulatory specifications
• Regulatory methods
• Purity profile – FDA vs. ICH
• Stability data presentation
• Stability protocol

Stability and Methods of Validation:

• Stability testing – FDA vs. ICH Guideline
• Stability protocol
• Methods validation – Extent of data required
• Getting ready for the pre-approval inspections
• Process Analytical Technologies-New FDA Initiatives

Mukund Chorghade

G

Container and Closure Systems / Analytical Methods:

• Current guidelines for container closure system
• Analytical methods: regulatory methods and regulatory specifications
• Compendial testing

Labeling:

Drug Master File (DMF):

• What is the DMF?
• When necessary?
• DMF – various types

Mukund Chorghade

H

SUPAC and BACPAC: Post Approval Changes

• Supplements and data requirements
• Types of supplements and data requirements
• When is prior approval necessary?
• Post-approval changes – SUPAC
• Immediate release Oral Dosage Form - SUPAC
• Modified Release Oral Dosage Form – SUPAC
• Semi-solids – SUPAC
• Current craft SUPAC guidances
• Post-approval changes – BACPAC
• ANDA

Mukund Chorghade

I