Current Edition

Ensuring a Carefully Designed and Executed Product Packaging Interaction Study for Concise Cost-Effective Evidence in Support of New Drug Product Development

The US Food and Drug Administration (FDA) Guidance

for Industry document ‘Container Closure Systems for

Packaging Human Drugs and Biologics’, addresses the review

and evaluation of packaging requirements. According to this

document, each new drug application (NDA) or abbreviated

new drug application (ANDA) should contain sufficient

information to demonstrate that a proposed container

closure system and its components are suitable for its

intended use. Last, but not least, Mike Ludlow, Technical

Study Manager, CMC Analytical Services at LGC, focuses on

product packaging and new drug development.