Issue Date: August 14, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): Pharmaceutical Quality, Chemistry, Manufacturing, and Controls (CMC)
Status: Draft
Container Closure Systems for Human Drugs and Biological Products
This draft guidance provides a risk-based framework for evaluating the quality of container closure systems (CCSs) used with human drugs and biological products, including quality assessments and quality control of packaging materials and components. It applies to new applications, amendments, supplements, and legally marketed drugs under section 505G, and FDA intends to issue supplementary topic-specific guidances on evaluating novel CCSs and on extractables and leachables testing.
Download the Guidance Document
