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# Guidance on Risk-Based Approach to Drug Packaging Systems
- URL: https://www.fdaweb.com/guidance-on-risk-based-approach-to-drug-packaging-systems/
- Published: 2026-08-13T12:00:00.000Z
- Updated: 2026-09-14T13:45:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161623

FDA has issued a draft guidance proposing a risk-based framework for evaluating the container-closure systems used to package human drugs and biologics. The draft, [“Container Closure Systems for Human Drugs and Biological Products,”](https://www.fda.gov/media/194220/download?ref=fdaweb.com) covers packaging systems for drugs, biologics and combination products and addresses the quality assessment and control of packaging materials and components.

FDA says the framework would consider factors including the safety of packaging materials, protection of the product, packaging performance, manufacturing processes, and storage and handling conditions. The guidance also provides considerations for specific dosage forms, including inhaled, injectable, ophthalmic, oral, topical and transdermal products.

The agency recommends that manufacturers evaluate container closure systems using a risk-management process because packaging components can interact with drug products and potentially affect quality, including through extractables and leachables.

The draft also addresses quality assessments, suitability evaluations, quality control, stability testing and additional testing related to shipping, handling and storage. Recommendations cover information to be submitted in marketing applications, investigational applications and master files, as well as reporting postapproval packaging changes.