stability testing container closure system
- Guideline or reference source
- ICHQ1A Stability testing of new drug substances and drug products
- Definition
- Stability testing conducted on the dosage form packaged in the container closure system proposed for marketing (including, as appropriate, any secondary packaging and container label). Any available studies carried out on the drug product outside its immediate container or in other packaging materials can form a useful part of the stress testing of the dosage form or can be considered as supporting information, respectively.
- Broader Term
- stability test
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