Glossary
Container Closure System
The container and its closure treated as one protective system, which must protect the product from foreseeable external factors during storage and use.
Details
The essential point is that the container and the closure are assessed as one system rather than separately. The most frequently cited sentence is that the container closure system does not provide adequate protection against foreseeable external factors in storage and use (211.94(b)), and for injectables the absence of a depyrogenation treatment and its validation is cited alongside it (211.94(c)). Whether stability testing was performed in the same container closure combination as the marketed product (211.166(a)(4)) is also checked.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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As it relates to your media fills, your response stated that a matrix, to include “all products, product sizes, container closure systems, etc.,” shall be developed and where significant gaps are identified, a media fill will be executed in June 2025.
FDA · FDA Warning Letter · 2025-11-25 -
Specifically, the stock solution was stored in an unclassified area for further use after the container closure system had been punctured multiple times, and therefore compromised, throughout the assigned expiry period.
FDA · FDA Warning Letter · 2021-11-16 -
Your firm failed to ensure container closure systems provide protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product (21 CFR 211.94(b)).
FDA · FDA Warning Letter · 2022-12-20
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
21 CFR 211.94 Drug product containers and closures, (b); FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs and Biologics (1999-07)GRM Regulatory Glossary
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