Control of materials is critical to ensure manufacturing consistency, resulting safety, quality and effectiveness of a product, and ultimately its continuous supply. FDA performs inspections to evaluate compliance with regulations applicable to material management systems. Material controls evaluated on inspections and applicable regulations will be discussed, followed by examples of recent inspectional observations from Forms FDA 483 issued to manufacturers of CBER-regulated products.

Subject area:
Biologics

Objectives (If applicable):
N/A

Target Audience (If applicable):
Analytical chemists
QA/QC analysts
R&D scientists, managers
Team members in CMC development projects
Manufacturing scientists, managers
Regulatory affairs specialists
Contract research organizations
Contract manufacturing organizations