Regulatory Class - Parts of CMC

Question 1

Parts of CMC Section

Answer 1

Drug Substance

Drug Product

Question 2

Parts of CMC Section: Drug Substance

Answer 2

General Information
Manufacture
Characterization (Structure Elucidation)
Control of drug substance (Specifications)
Reference standards or materials
Container Closure System
Stability

Question 3

Parts of CMC Section: Drug Substance: General Information

Answer 3

Nomenclature
Structure
General properties

Question 4

Parts of CMC Section: Drug Substance: Manufacture

Answer 4

Manufacturer

Method of manufacture

Question 5

Parts of CMC Section: Drug Product

Answer 5

Description and Composition of the drug product
Pharmaceutical Development
Manufacture
Control of Excipients (Specifications)
Control of Drug Product (Specifications)
Justification of Specifications
Reference Standards or Materials
Container Closure System
Stability
Additional Information of Biotechnology Products

Question 6

Parts of CMC Section: Drug Product: Pharmaceutical development

Answer 6

Components of the drug product (-drug substance -excipients)
Drug product (-formulation development -overages)
Manufacturing process development
Container closure system
Microbiological attributes
Compatibility

Question 7

Parts of CMC Section: Drug Product: Manufacture

Answer 7

Manufacturer

Method of Manufacture

Question 8

Parts of CMC Section: Drug Product: Control of Excipients

Answer 8

Compendial - nonnovel excipients
Noncompendial - nonnovel excipients
Novel excipients
Excipients of human or animal origin

Question 9

Parts of CMC Section: Drug Product: Control of Drug Product

Answer 9

Degradation Products
Residual Solvents
Miscellaneous drug product impurities

Question 10

Parts of CMC Section: Drug Product: Additional Information of Biotechnology products

Answer 10

Viral adventitious agents and transmissible spongiform encephalopathy agent
For protein products