Module 14 2022

22/03/2022

Indications for use

Important to describe clearly what it will be used for, including • By whom? • How it will be used?

• In what setting? (at home, in a hospital) • Any restrictions on use / contraindications?

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

19

Manufacturing information

• Manufacturer(s) details – who does what • Overview of the manufacturing process and controls • Do include important activities – critical steps/conditions • Do include a Flow Diagram • Do not need to include a batch manufacturing record (too much detail)

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

20

10