container closure system
- Guideline or reference source
- ICHQ1A Stability testing of new drug substances and drug products
- ICHQ3D Guideline for elemental impurities
- Definition
- The sum of packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the drug product. A packaging system is equivalent to a container closure system.
- Used For
- container closure
- marketing pack
- Narrower Term
- immediate container
- intermediate packaging
- outer packaging
- Related Term
- container
- drug product
- fill volume
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