Article
FDA Issues Draft Guidance On Container Closure Systems For Human Drugs And Biological Products
The FDA has released new draft guidance establishing a comprehensive risk-based framework for evaluating container closure systems used in pharmaceutical packaging, marking a significant update from its 1999 guidance. This framework addresses five critical factors including material safety, environmental protection, performance standards, manufacturing impacts, and storage considerations, with particular emphasis on leachables assessment and quality control programs across different drug delivery routes.
Steptoe LLP